A Randomized Controlled Trial of Bupivacaine for Local Pain Control Following Perineal Laceration Repair in Patients With Pre-existing Epidural Analgesia

The prevalence of perineal lacerations is more than 75% of all vaginal deliveries. The repair of such lacerations in the institution is usually done using lidocaine for non-epiduralized patients versus no local injection in patients with a pre-existing epidural analgesia. The prevalence of epidural analgesia use among women who underwent vaginal delivery in cross-sectional study of over 2 million deliveries in the United States was 71.1%. Once the analgesic effect of the epidural analgesia fades, the laceration may cause uncontrolled postpartum pain which can affect both the physical and mental recovery period, extend hospital stays, and increase the potential for serious adverse reactions with pain medications.
The research hypothesis of this study is that adding a locally injected analgesic, which will take effect once the epidural analgesia fades, may alleviate perineal pain and improve women's overall well-being and satisfaction.
This is a superiority two-arm, quadruple-blinded, prospective randomized controlled trial with the objective to determine if prolonged analgesia and higher rate of maternal satisfaction are found when bupivacaine with epinephrine infiltration is used for perineal repair as compared to sham injection in patients with pre-existing effective epidural analgesia at time of perineal laceration repair. Women with a working epidural analgesia, and status post a vaginal delivery involving a second-degree laceration will be invited to participate. Women in the local anesthesia (LA) arm will get a LA injected to the laceration and women in the sham arm will get an injection with saline. The differences in perineal pain between the groups will be evaluated at time of the first analgesic (TFA) demand, maternal satisfaction at 24 hours, and visual analog scale (VAS) pain score.

Start Date01 Feb 2025

Sponsor / Collaborator

Montefiore Medical Center

NCT06685107

/ RecruitingNot ApplicableIIT

Combination of Virtual Reality and Standard of Care Versus Standard of Care Alone for Acute Musculoskeletal Pain Management in Geriatric Emergency Department Patients: A Randomized Clinical Trial

The proposed Virtual Reality as an Adjunct to Pain Management for Geriatric Patients in the ED (VRAP-ED) project will take place in the Emergency Medicine Department at Maimonides Medical Center. It seeks to enhance the analgesic practices for geriatric patients with acute painful conditions in the emergency setting. Although virtual reality (VR) has demonstrated effectiveness in reducing pain and anxiety in various clinical settings for juveniles and adults, the analgesic efficacy of VR for geriatric ED patients lacks established data. The project will use a geriatric-focused VR platform.
The project intends to improve pain management for almost 200 geriatric patients by evaluating the effectiveness of virtual reality (VR) in reducing pain and its impact on anxiety & stress reduction. The research project will conduct a randomized clinical trial to investigate the analgesic efficacy and impact on anxiety & stress by using VR as an adjunct to the standard of care (SOC) for pain management in elderly patients presenting to the ED with acute musculoskeletal pain. This will be investigated through a prospective, randomized, non-blinded clinical trial conducted over two years. Eligible patients will be randomly assigned to either the control (SOC) or intervention (SOC+VR) groups. The expected outcomes of this research study will provide insight into the feasibility of using VR in a busy emergency setting for one of the most commonly encountered painful syndromes and to assess the analgesic efficacy as well as the satisfaction of VR application by both patients and ED clinicians.

Start Date18 Nov 2024

Sponsor / Collaborator

Maimonides Medical Center

NCT06040840

/ CompletedNot Applicable

WALANT Versus Axillary Brachial Plexus Block in Carpal Tunnel Release: a Non-inferiority Randomized Controlled Trial

Carpal tunnel syndrome (CTS) is a common medical condition that remains one of the most frequently reported forms of median nerve compression. Surgical procedure is a treatment option for CTS. For this surgery of the upper extremity, regional anesthesia (RA) is the strategy that should be systematically preferred because it is associated with shorter postanesthetic care and less pain compared to general anesthesia. Multiple approaches to block the brachial plexus are available for the surgery of the upper extremity below the elbow, but the axillary block (BAX) remains the most common approach as it is associated with low side effects.
One of the most significant recent advances in the surgery of the upper extremity has been the emergence of Wide-Awake Local Anesthesia No Tourniquet (WALANT) technique. WALANT is an infiltration technique of a local anesthetic (LA) (lidocaine) and a hemostatic agent (epinephrine) directly into the operative site to induce anesthesia and hemostasis in the area of the surgical procedure to provide conditions suitable for hand surgery without sedation and tourniquet. Given its effectiveness and low side effects, WALANT could be a technique of choice in ambulatory surgery.
The main objective of this non-inferiority, prospective, randomized, open-label, parallel-group controlled trial is to assess the efficacy of WALANT technique compared to BAX in carpal tunnel release (CTR).

Start Date13 May 2024

Sponsor / Collaborator

Clinique Ambroise Paré SA

100 Clinical Results associated with Epinephrine Bitartrate

100 Translational Medicine associated with Epinephrine Bitartrate

100 Patents (Medical) associated with Epinephrine Bitartrate

64,788

Literatures (Medical) associated with Epinephrine Bitartrate

31 Dec 2025·PLATELETS

Transcriptomic and functional characterization of megakaryocytic-derived platelet-like particles: impaired aggregation and prominent anti-tumor effects

Article

Author: Whalen, Michael ; Rashid, Kameron ; Horvath, Anelia ; Lee, Norman H. ; Sidahmed, Alfateh ; Perera, Minoli A. ; Maggirwar, Sanjay B. ; Garofano, Kaitlin ; Suwunnakorn, Sumanun ; O’Brien, Travis J. ; Mariani, Vera

Platelet-like particles (PLPs), derived from megakaryocytic cell lines MEG-01 and K-562, are widely used as a surrogate to study platelet formation and function. We demonstrate by RNA-Seq that PLPs are transcriptionally distinct from platelets. Expression of key genes in signaling pathways promoting platelet activation/aggregation, such as the PI3K/AKT, protein kinase A, phospholipase C, and α-adrenergic and GP6 receptor pathways, was missing or under-expressed in PLPs. Functionally, PLPs do not aggregate following epinephrine, collagen, or ADP stimulation. While PLPs aggregated in response to thrombin, they did not display enhanced expression of surface markers P-selectin and activated α_2bβ₃, in contrast to platelets. We have previously demonstrated that platelets physically couple to MDA-PCa-2b and RC77T/E prostate cancer (PCa) cells via specific ligand-receptor interactions, leading to platelet-stimulated cell invasiveness and apoptotic resistance, and reciprocal cell-induced platelet aggregation. In contrast, PLP interactions with PCa cells inhibited both cell invasion and apoptotic resistance while failing to promote PLP aggregation. Moreover, PLPs reduced platelet-PCa cell interactions and antagonized platelet-stimulated oncogenic effects in PCa cells. RNA-Seq analysis identified candidate ligand-transmembrane protein combinations involved in anti-tumorigenic signaling of PLPs to PCa cells. Antibody neutralization of the TIMP3-MMP15 and VEGFB-FGFR1 signaling axes reversed PLP-mediated anti-invasion and apoptotic sensitization, respectively. In summary, PLPs lack many transcriptomic, molecular and functional features of platelets and possess novel anti-tumorigenic properties. These findings indicate that PLPs may have a potential therapeutic role in targeting and disrupting the oncogenic signaling between platelets and cancer cells, offering a new avenue for anti-cancer strategies.

01 May 2025·TALANTA

Fe–Co–Fe prussian blue analogues loaded nitrogen doped carbon quantum dots for effective epinephrine detection

Article

Author: Wang, Ying ; Xin, Jianjiao ; Liu, Yikun ; Wang, Xinming ; Song, Daozheng ; Pang, Haijun ; Ma, Huiyuan ; O'Halloran, Kevin P ; Yang, Guixin ; Chu, Mingyue

Epinephrine (Ep) is an important neurotransmitter, which plays an important role in the nervous system and glycogen metabolism of living organisms. Hence, a novel NCQDs/FeCoFe-PBA composite with FeCoFe-Prussian blue analogues (PBA) as the core and nitrogen-doped carbon quantum dots (NCQDs) as the shell was constructed by a one-pot hydrothermal method, and it was used for the efficient detection of Ep. As a good electroactive material, NCQDs in the composite not only improved the weak conductivity of FeCoFe-PBA, but also limited the self-aggregation of FeCoFe-PBA, and formed a uniform shell on FeCoFe-PBA. The heterogeneous structure formed between the core and shell layer resulting in NCQDs/FeCoFe-PBA nanocomposites with more active sites, electron transport channels and a larger effective surface area. Further, under optimal conditions, the electrochemical method was used to evaluate the NCQDs/FeCoFe-PBA sensor, and the results revealed that the sensor had exceptional sensing performance for Ep, with an excellent linear range from 0.01 to 306.7 μM and a low detection limit of 0.002 μM. Simultaneously, the practicality, repeatability, and stability tests yielded positive results, confirming the feasibility of practical development and application of NCQDs/FeCoFe-PBA.

01 May 2025·JOURNAL OF PHOTOCHEMISTRY AND PHOTOBIOLOGY A-CHEMISTRY

Surface passivation aided turn-on fluorescence sensor based on pepsin tailored gold nanoclusters for the selective determination of 5-hydroxyindoleacetic acid

Author: Chandran, Amoolya ; Kumar, K. Girish

Monoamine neurotransmitters, its precursors and metabolites are considered as promising biomarkers for the prognosis of many disease conditions.This article describes the synthesis, features and performance of pepsin capped gold nanoclusters (PEP-AuNC) based fluorescence sensor for the sensitive determination of 5-Hydroxyindoleacetic Acid (5-HIAA).PEP-AuNCs, with low toxicity and excellent photo stability were prepared by a simple, one pot strategy in which pepsin served a dual role, as a protecting agent as well as a reducing agent which turned the synthesis pathway into a greener one.PEP-AuNCs were successfully characterized and its efficacy in sensing 5-HIAA has been investigated.The sensor achieved a limit of detection and limit of quantification of 5.01 x 10^-8 M and 1.67 x 10^-7 M, resp. for 5-HIAA.Mechanism behind the sensing of 5-HIAA by PEP-AuNCs has been investigated with the aid of different anal. techniques.The sensing has been ascertained to be due to the passivation of the surface of the PEP-AuNC by electron rich indolyl and carboxylic acid group present in the analyte.The results obtained from selectivity study and spike recovery anal. of synthetic physiol. fluids justify the practical utility of the proposed sensor as well.

News (Medical) associated with Epinephrine Bitartrate

21 Feb 2025

·www.globenewswire.com

ARS Pharmaceuticals Announces OptumRx, Cigna Healthcare and Navitus Health Systems Add neffy® (Epinephrine Nasal Spray) to National Formularies, Further Expanding Coverage for Patients

Approximately five months after launch, the inclusion of neffy on these three additional formularies has expanded access to half of all patients and caregivers managing Type 1 allergic reactions, bringing the total number of formulary platforms covering neffy to 30 SAN DIEGO, Feb. 20, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced today that Cigna Healthcare, Navitus Health Systems and OptumRx, through their Group Purchasing Organization (GPO) Emisar, have added neffy® (epinephrine nasal spray) to their National Formularies. “Millions of patients nationwide now have improved access to neffy through their commercial insurance, thanks to coverage from leading pharmaceutical benefit managers and health plans. neffy will also be available at the lowest branded copay for patients insured by OptumRx, Cigna Healthcare, and Navitus Health Systems - without the need for prior authorizations or restrictive step therapies,” said Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “As a result, more patients will qualify for the low copay price of $25 for neffy, when they apply the ARS Pharma copay assistance, and healthcare providers can prescribe it without the need for additional paperwork.” “This announcement also underscores the critical demand for a nasal spray epinephrine option within the severe allergy community and we remain committed to ensuring continued access for as many patients and caregivers as possible. While Emisar represents both OptumRx and UnitedHealthcare as their GPO at this time only OptumRx has agreed to the Emisar terms. ARS Pharma is working closely with UnitedHealthcare, as one of the country’s largest healthcare providers, to add neffy to their formulary as soon as possible,” said Lowenthal. The addition of neffy to these formularies improves coverage for the approximately 20 million people who have been diagnosed and treated for the more severe Type I allergic reactions that may lead to anaphylaxis and need epinephrine therapy to protect themselves in their daily lives. To assist patients in navigating coverage and affordability challenges, ARS Pharma offers a number of programs for patients and caregivers. For more information, visit www.neffy.com/savings. neffy 2 mg is for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.). It is the first and only FDA-approved epinephrine nasal spray that provides a needle-free alternative to traditional injectable epinephrine. It’s simple and intuitive design enables rapid administration, helping patients and caregivers act quickly and confidently, and the small size is easy to carry. Additionally, neffy has a shelf-life of 30 months and temperature exclusions up to 122 degrees Fahrenheit. The supplemental NDA for neffy 1 mg, for children over four years of age who weigh 15 to 30 kg, has a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025. Based on review timelines and subject to approval, product availability of neffy 1 mg is expected by the end of May 2025. ARS Pharma anticipates that by the epinephrine prescription renewal period, which occurs over the summer for many children in the United States, that school age children who meet the weight and age criteria will have access to neffy. About neffy® neffy is an intranasal epinephrine product for patients with Type I allergic reactions including food, medications, and insect bites that could lead to life-threatening anaphylaxis. INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray) INDICATION neffy 2 mg is indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater. IMPORTANT SAFETY INFORMATION It is recommended that patients are prescribed and have immediate access to two neffy nasal sprays at all times. In the absence of clinical improvement or if symptoms worsen after initial treatment, administer a second dose of neffy in the same nostril with a new nasal spray starting 5 minutes after the first dose. neffy is for use in the nose only. Advise patients when to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required. Absorption of neffy may be affected by underlying structural or anatomical nasal conditions. Administer with caution to patients who have heart disease; epinephrine may aggravate angina pectoris or produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or taking cardiac glycosides, diuretics, or anti-arrhythmics. The presence of a sulfite in neffy should not deter use. neffy may alter nasal mucosa for up to 2 weeks after administration and increase systemic absorption of nasal products, including neffy. Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions. Epinephrine can temporarily exacerbate the underlying condition or increase symptoms in patients with the following: hyperthyroidism, Parkinson’s disease, diabetes, renal impairment. Epinephrine should be administered with caution in patients with these conditions, including elderly patients and pregnant women. Adverse reactions to neffy may include throat irritation, intranasal paresthesia, headache, nasal discomfort, feeling jittery, paresthesia, fatigue, tremor, rhinorrhea, nasal pruritus, sneezing, abdominal pain, gingival pain, hypoesthesia oral, nasal congestion, dizziness, nausea, and vomiting. These are not all of the possible side effects of neffy. To report suspected adverse reactions, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For additional information on neffy, please see Full Prescribing Information at www.neffy.com. About Type I Allergic Reactions Including Anaphylaxis Type I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine auto-injectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. Even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency. About ARS Pharmaceuticals, Inc. ARS Pharmaceuticals is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy® 2 mg (trade name EURneffy® in the EU) (previously referred to as ARS-1), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visit www.ars-pharma.com. Forward-Looking Statements Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the expected impact from the inclusion of neffy on OptumRx, Cigna Healthcare and Navitus Health Systems’ National Formularies; ARS Pharmaceuticals’ expectation that other payors, such as UnitedHealthcare, will agree to terms to provide access to neffy and the timing by which they will provide such access, the critical demand for a nasal spray epinephrine option, the expectation that neffy will save lives; the effectiveness of neffy; the expected timing for product availability of neffy 1 mg; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “expects,” “if,” “may,” “potential,” “on track to,” “plans,” “will,” “would,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharmaceuticals’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: potential safety and other complications from neffy; ARS Pharmaceuticals’ reliance on its licensing partners; the ability to maintain regulatory approval for neffy in its currently approved indication and to obtain and maintain regulatory approval for neffy for additional indications; the labelling for neffy in any future indication or patient population, if approved; the scope, progress and expansion of developing and commercializing neffy; the potential for governments and payors to delay, limit or deny coverage for neffy; the size and growth of the market therefor and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharmaceuticals’ ability to protect its intellectual property position; and the impact of government laws and regulations. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in ARS Pharmaceuticals’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the Securities and Exchange Commission (“SEC”) on November 13, 2024. These documents can also be accessed on ARS Pharmaceuticals’ website at www.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab. The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharmaceuticals assumes no obligation and does not intend to update these forward-looking statements, except as required by law. For more information, visit www.ars-pharma.com, and follow us on LinkedIn and X. ARS Investor Contact:Justin ChakmaARS Pharmaceuticalsjustinc@ars-pharma.com ARS Media Contact:Christy CurranSam Brown Inc.615.414.8668christycurran@sambrown.com

Drug Approval

12 Feb 2025

·investors.aquestive.com

Aquestive Therapeutics to Present New Findings on Anaphylm™ (Epinephrine Sublingual Film) at the 2025 AAAAI Annual Meeting

Data show Anaphylm maintains consistent stability and potency under extreme temperature and real-world conditions, including heat, freezing, and water submersion New findings demonstrate dosing of Anaphylm results in consistent epinephrine absorption without impacting safety or pharmacodynamic (PD) parameters Anaphylm pharmacokinetic (PK) and PD are not impacted by oral swelling Median symptom resolution time was 12 minutes compared to 74 minutes without treatment; mean angioedema symptom resolution time was within 5 minutes. WARREN, N.J., Feb. 12, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that multiple presentations highlighting results from the investigational use of Anaphylm epinephrine sublingual film in the treatment of severe allergic reactions, including anaphylaxis, will be featured at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting. The meeting will take place February 28 - March 3, 2025, in San Diego, CA. “These latest results reinforce the strength of our clinical data and the potential of our product candidate Anaphylm as a reliable, portable, and effective treatment for anaphylaxis,” said Daniel Barber, Chief Executive Officer of Aquestive. “Anaphylm was designed to offer patients a more accessible option for emergency epinephrine administration, without the need for an injection or device, if approved by the FDA. These data further demonstrate Anaphylm’s performance under real-world conditions in resolving angioedema symptoms.” In the Phase 2 open-label Oral Anaphylm Symptom Intervention Study (“OASIS”) study, adults with Oral Allergy Syndrome (n=36) received Anaphylm under different conditions, including single and repeat dosing with and without oral allergen challenge (OAC), alongside intramuscular (IM) epinephrine injection as a comparator. The study found that: Anaphylm matched or exceeded IM epinephrine in all key PK parameters. No significant differences in drug performance compared to IM epinephrine were observed, regardless of whether patients had an oral allergen challenge or not. Median symptom resolution time was 12 minutes compared to 74 minutes without treatment; mean angioedema symptom resolution time was within 5 minutes. Additionally, new findings indicate that Anaphylm maintains prior reported top line data in support of stability and potency despite exposure to extreme temperatures and environmental conditions, underscoring its performance in real-world settings where patients may need it most. Poster presentation details are as follows: Poster Title: Durability of Anaphylm (Epinephrine Sublingual Film) under Real-World Use Poster Number: 304 Lead Author: Steve Wargacki, PhD Presentation Time: Saturday, Mar. 1, 9:45 am – 10:45 am PT Poster Title: Stability Results of Anaphylm (Epinephrine Sublingual Film) Under Extreme Temperature Conditions Poster Number: 305 Lead Author: Steve Wargacki, PhD Presentation Time: Saturday, Mar. 1, 9:45 am – 10:45 am PT Poster Title: Epinephrine Delivered via Sublingual Film (Anaphylm): Pharmacokinetic and Pharmacodynamic Responses Poster Number: 312 Lead Author: Carl N. Kraus, MD Presentation Time: Saturday, Mar. 1, 9:45 am – 10:45 am PT Poster Title: Oral Anaphylm Symptom Intervention Study (OASIS): Pharmacokinetics, Pharmacodynamics, and Symptom Resolution in Allergy Patients Poster Number: L18 Lead Author: Carl N. Kraus, MD Presentation Time: Saturday, Mar. 1, 9:45 am – 10:45 am PT The abstracts are available online at annualmeeting.aaaai.org, as well as on the Company’s website on the Scientific events page of the of the Investor section. About Anaphylm™ (epinephrine) Sublingual Film Anaphylm™ (epinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate. Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. The Anaphylm trade name for AQST-109 has been conditionally approved by the U.S. Food and Drug Administration (FDA). Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate. About Aquestive Therapeutics Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by the Company and its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product candidate for the treatment of severe allergic reactions, including anaphylaxis, and an earlier stage epinephrine prodrug topical gel product candidate for possible various dermatology conditions. For more information, visit Aquestive.com and follow us on LinkedIn. Forward-Looking Statement Certain statements in this press release include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm™ (epinephrine) Sublingual Film through clinical development and approval by the FDA, including filing the NDA for Anaphylm with the FDA and the following launch of Anaphylm, if approved by the FDA; that the results of the Company’s clinical studies for Anaphylm are sufficient to support submission of the NDA for approval of Anaphylm by the FDA; the advancement of the Company’s product candidate AQST-108 through clinical development and approval by the FDA for possible various dermatology conditions; the potential benefits our products and product candidates could bring to patients; and business strategies, market opportunities, and other statements that are not historical facts. These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with our development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans, including those relating to Anaphylm (including for pediatric patients) and AQST-108; risk of delays in advancement of the regulatory approval process through the FDA of our product candidates, including the filing of the respective NDAs, including for Anaphylm and AQST-108, or the failure to receive FDA approval at all of any of these product candidates; risk of the Company’s ability to generate sufficient clinical data for approval of our product candidates, including with respect to our pharmacokinetic and pharmacodynamic comparability submission for FDA approval of Anaphylm; risk of the Company’s ability to address the FDA’s comments on the Company’s clinical trials and other concerns identified in the FDA Type C meeting minutes for Anaphylm, including the risk that the FDA may require additional clinical studies for approval of Anaphylm; risk of the success of any competing products; risks and uncertainties inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of sufficient capital and cash resources, including sufficient access to available debt and equity financing, including under our ATM facility and the Lincoln Park Purchase Agreement, and revenues from operations, to satisfy all of our short-term and longer-term liquidity and cash requirements and other cash needs, at the times and in the amounts needed, including to fund commercialization activities relating to fund future clinical development and commercial activities for our product candidates, including Anaphylm, should these product candidates be approved by the FDA; risk of eroding market share for Suboxone® and risk as a sunsetting product, which accounts for the substantial part of our current operating revenue; risk of default of our debt instruments; risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties; risk of the rate and degree of market acceptance in the U.S. of Anaphylm and our other product candidates, should these product candidates be approved by the FDA, and for our licensed products in the U.S. and abroad; risk of the success of any competing products including generics; risk of the size and growth of our product markets; risk of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to our products; risk that our patent applications for our product candidates, including for Anaphylm, will not be timely issued, or issued at all, by the PTO; risk of unexpected patent developments; risk of legislation and regulatory actions and changes in laws or regulations affecting our business including relating to our products and products candidates and product pricing, reimbursement or access therefor; risk of loss of significant customers; risks related to claims and legal proceedings against Aquestive including patent infringement, securities, business torts, investigative, product safety or efficacy and antitrust litigation matters; risk of product recalls and withdrawals; risks related to any disruptions in our information technology networks and systems, including the impact of cybersecurity attacks; risk of increased cybersecurity attacks and data accessibility disruptions due to remote working arrangements; risk of adverse developments affecting the financial services industry; risks related to inflation and rising interest rates; risks related to the impact of the COVID-19 global pandemic and other pandemic diseases on our business, including with respect to our clinical trials and the site initiation, patient enrollment and timing and adequacy of those clinical trials, regulatory submissions and regulatory reviews and approvals of our product candidates, availability of pharmaceutical ingredients and other raw materials used in our products and product candidates, supply chain, manufacture and distribution of our products and product candidates; risks and uncertainties related to general economic, political (including the Ukraine and Israel wars and other acts of war and terrorism), business, industry, regulatory, financial and market conditions and other unusual items; and other uncertainties affecting us including those described in the "Risk Factors" section and in other sections included in the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by applicable law. PharmFilm® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners. Investor Contact: Brian Korb astr partners brian.korb@astrpartners.com

Clinical ResultPhase 2

21 Jan 2025

·www.globenewswire.com

ARS Pharmaceuticals Launches neffyinSchools Program Providing Free Life-Saving Needle-Free Epinephrine For Emergency Use to Eligible K-12 Schools

School administrators and nurses are encouraged to review applicable state laws and regulations to ensure neffy® (epinephrine nasal spray) 2 mg for undesignated use meets applicable state law requirements Interested schools can visit neffy.com/community-programs to apply SAN DIEGO, Jan. 21, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced today the launch of the neffyinSchools program. neffyinSchools provides eligible public and private K-12 schools in the U.S. with the opportunity to receive two cartons (four single use doses) of neffy® (epinephrine nasal spray) 2 mg for use in emergency situations at no cost to the school via the School Health Corp. SHConnect platform. neffy 2 mg is approved for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.). Participating schools will be eligible to receive replacement doses when the product is used or expires. “School nurses play a pivotal role in the health and wellbeing of students. Unexpected allergic reactions can happen at any time – including during the school day – so it is crucial to have epinephrine readily available to administer by nurses and other trained school officials. The neffyinSchools program will help schools to obtain epinephrine free of cost. This positions schools to be ready to provide emergency treatment for severe allergic reactions,” said Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America. Life-threatening, Type 1 allergic reactions can happen quickly and be caused by foods, insects, medication, exercise, or other unknown causes. It is estimated that one-quarter of anaphylactic reactions in schools are among students with previously undiagnosed allergies.1 Studies also show that food allergy affects approximately 1 in 20 school-aged children.2 "We are deeply committed to ensuring neffy is freely available to all eligible K-12 schools, providing life-saving epinephrine for emergency situations without fear or hesitation,” said Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “neffy is a groundbreaking device with a simple, needle-free design that we believe will make schools safer and better prepared to address anaphylaxis. While anaphylaxis can progress rapidly and occur at any time, many states must update their legislation to include nasal delivery in local epinephrine stocking and indemnification laws, for undesignated use, before it can be provided to schools." ARS Pharma will host a webinar for school nurses and administrators about neffy and the neffyinSchools program on January 22, 2025. Participants are encouraged to register here. For more information, including details about patient advocacy groups and resources for schools, visit www.neffy.com/community-programs. For specific inquiries, please email CommunityPrograms@ars-pharma.com. Ongoing updates will be provided on ARS LinkedIn and X pages. About neffyinSchoolsARS Pharma is committed to working with our communities to provide essential epinephrine in schools. Eligible public and private K-12 schools in the U.S. (excluding territories) will be able to receive two cartons (four single use doses) of neffy 2 mg for adults and children who weigh ≥30 kg (66 lbs.), in emergency situations. The neffyinSchools program is only for undesignated use, and children with prescriptions for epinephrine from their healthcare provider must continue to supply medication to their school in accordance with school guidelines. Schools must review applicable state legislation to ensure neffy meets the requirements of local epinephrine stocking and administration laws for undesignated use. The supplemental NDA for neffy 1 mg dose was granted priority review by the FDA and has a PDUFA date set for March 6, 2025. If approved, neffy 1 mg will be available to schools for students who weigh between 33 and 66 lbs. About neffy®neffy is an intranasal epinephrine product for patients with Type I allergic reactions including food, medications, and insect bites that could lead to life-threatening anaphylaxis. INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray) INDICATIONneffy 2 mg is indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater. IMPORTANT SAFETY INFORMATIONIt is recommended that patients are prescribed and have immediate access to two neffy nasal sprays at all times. In the absence of clinical improvement or if symptoms worsen after initial treatment, administer a second dose of neffy in the same nostril with a new nasal spray starting 5 minutes after the first dose. neffy is for use in the nose only. Advise patients when to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required. Absorption of neffy may be affected by underlying structural or anatomical nasal conditions. Administer with caution to patients who have heart disease; epinephrine may aggravate angina pectoris or produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or taking cardiac glycosides, diuretics, or anti-arrhythmics. The presence of a sulfite in neffy should not deter use. neffy may alter nasal mucosa for up to 2 weeks after administration and increase systemic absorption of nasal products, including neffy. Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions. Epinephrine can temporarily exacerbate the underlying condition or increase symptoms in patients with the following: hyperthyroidism, Parkinson’s disease, diabetes, renal impairment. Epinephrine should be administered with caution in patients with these conditions, including elderly patients and pregnant women. Adverse reactions to neffy may include throat irritation, intranasal paresthesia, headache, nasal discomfort, feeling jittery, paresthesia, fatigue, tremor, rhinorrhea, nasal pruritus, sneezing, abdominal pain, gingival pain, hypoesthesia oral, nasal congestion, dizziness, nausea, and vomiting. These are not all of the possible side effects of neffy. To report suspected adverse reactions, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For additional information on neffy, please see Full Prescribing Information at www.neffy.com. About Type I Allergic Reactions Including Anaphylaxis Type I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency. About ARS Pharmaceuticals, Inc.ARS Pharmaceuticals is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy® 2 mg (trade name EURneffy® in the EU) (previously referred to as ARS-1), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visit www.ars-pharma.com. Forward-Looking Statements Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the expected timing and launch of neffyinSchools; the needle-free profile of neffy and making neffy available at no cost to eligible public and private K-12 schools increasing the likelihood that such schools will both carry and administer epinephrine to students experiencing an allergic reaction; the expectation that neffy will save lives; the potential for neffy to qualify under local and state stocking and indemnification laws for undesignated use; the expected timing for obtaining regulatory approval for neffy 1 mg and the availability thereof; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “expects,” “if,” “may,” “potential,” “on track to,” “plans,” “will,” “would,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharmaceuticals’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: potential safety and other complications from neffy; ARS Pharmaceuticals may not receive the anticipated benefits from the neffyinSchools program; public and private schools may not participate in the neffyinSchools program to the degree or on the timelines expected by ARS Pharmaceuticals; the scope, progress and expansion of developing and commercializing neffy; the potential for payors to delay, limit or deny coverage for neffy; the size and growth of the market therefor and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; and ARS Pharmaceuticals’ ability to protect its intellectual property position; the impact of government laws and regulations. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in ARS Pharmaceuticals’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the Securities and Exchange Commission (“SEC”) on November 13, 2024. These documents can also be accessed on ARS Pharmaceuticals’ website at www.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab. The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharmaceuticals assumes no obligation and does not intend to update these forward-looking statements, except as required by law. ARS Investor Contact:Justin ChakmaARS Pharmaceuticalsjustinc@ars-pharma.com ARS Media Contact:Christy CurranSam Brown Inc. 615.414.8668christycurran@sambrown.com References: Hogue SL, Muniz R, Herrem C, Silvia S, White MV. Barriers to the Administration of Epinephrine in Schools. J Sch Health. 2018 May;88(5):396-404. doi: 10.1111/josh.12620. PMID: 29609214.Kao, L. M., Wang, J., Kagan, O., Russell, A., Mustafa, S. S., Houdek, D., Smith, B., & Gupta, R. (2018). School nurse perspectives on school policies for food allergy and anaphylaxis. Annals of Allergy, Asthma and Immunology, 120(3), 304-309. https://doi.org/10.1016/j.anai.2017.12.019

Drug ApprovalPriority ReviewNDA

100 Deals associated with Epinephrine Bitartrate

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KEGG	Wiki	ATC	Drug Bank
D02149	Epinephrine Bitartrate	C01CA24 B02BC09 S01EA01	DB00668

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Indication	Country/Location	Organization	Date
Shock, Septic	US	International Medication Systems Ltd.	15 Aug 2022
Hypotension	US	Hospira, Inc.	05 Nov 2019
Asthma	US	Bausch & Lomb (Australia) Pty Ltd.	09 Mar 1956

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Bronchial Spasm	Phase 2	US	Amphastar Pharmaceuticals, Inc.	01 Aug 2010
Dyspnea	Phase 2	US	Amphastar Pharmaceuticals, Inc.	01 Aug 2010

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EPIPHAST (ACAAI2022)	Phase 1	-	-	Formulation 5: 10 mg	wgkxpqwoyc(uxeesbemnt) = xkywgdiiyr pwofgygxam (yurerqohxm ) View more	Positive	10 Nov 2022
				Formulation 5: 12 mg	wgkxpqwoyc(uxeesbemnt) = iljtgssvfx pwofgygxam (yurerqohxm ) View more
NCT03860974 (CTgov)	Phase 4	-	100	epinephrine+ropivacaine (Serratus Plane (Single Injection))	xbaorqvydg(bsahlvwgsm) = zovgvdsaku dffbwoisuj (btghehrhnn, cygqeejvdf - vxbgfwmevj) View more	-	21 Sep 2022
				Paravertebral block (single injection) (Paravertebral (Single Injection))	xbaorqvydg(bsahlvwgsm) = murnldwhfl dffbwoisuj (btghehrhnn, vvgepjmiwz - ratqpqdsjd) View more
NCT04688346 (CTgov)	Phase 2/3	Drug-Related Side Effects and Adverse Reactions	13	HemeRX epinephrine pellets (Control)	itldhcwpdc(hfrshkwscs) = okjgjwliua jqkempbtjj (ycpaoklaqt, xltirtfomx - wyvcsbrqgk) View more	-	13 May 2021
				HemeRX epinephrine pellets (Intervention)	itldhcwpdc(hfrshkwscs) = alnudkurol jqkempbtjj (ycpaoklaqt, amqkzzhcgu - rdttjgclat) View more
NCT01602692 (CTgov)	Phase 4	Postoperative Nausea and Vomiting \| Pain, Postoperative	40	Tumescent Solution with dilute epinephrine (Tumescent Solution With Dilute Epinephrine)	ohtppyrdhi(usgodmjzyt) = fjytvwomxj gmqawaxfck (uzdlvcnbnx, ruqzapuypy - kceimaoubl) View more	-	05 Oct 2020
				Tumescent solution with dilute lidocaine and epinephrine (Tumescent Solution With Dilute Lidocaine and Epinephrine)	ohtppyrdhi(usgodmjzyt) = vazwrbwxjx gmqawaxfck (uzdlvcnbnx, yxkkzmgwwc - xgxxcralub) View more
NCT02280291 (CTgov)	Phase 4	Pain \| Fractures, Bone	100	epinephrine+lidocaine+bupivacaine (Ankle Single Shot Block (SSB))	liofqvcltd(agrjtdcysr) = birkhgfevm limhsewoex (rmiganxkts, qrzjffmfqh - ditteuaqdk) View more	-	30 Mar 2020
				epinephrine+lidocaine+bupivacaine (Ankle OnQ (Continuos Sedation OnQ Pump))	liofqvcltd(agrjtdcysr) = iubvyfqyyw limhsewoex (rmiganxkts, hsaetcdgay - lxscekyrqm) View more
NCT00624650 (HEAL, CTgov)	Phase 2	Acute Lung Injury	33	Epinephrine+Fluid Bolus (crystalloid or albumin)+Norepinephrine+Phenylephrine+Diuresis (furosemide) part I+Dobutamine+Vasopressin (Modified FACTT (Control))	sgyfsdcfkc(jdbmrtxfee) = tzqfhlfieo wqxfecvotu (gjxaqklkki, ztvoxvcsqc - jkovqhtwpc) View more	-	10 Sep 2019
				Epinephrine+Fluid Bolus (crystalloid or albumin)+Norepinephrine+Phenylephrine+Diuresis (furosemide) part I+Dobutamine+Vasopressin (EVLW)	sgyfsdcfkc(jdbmrtxfee) = ypcurfecod wqxfecvotu (gjxaqklkki, jbgutsncyb - cvqwevhebp) View more
NCT02104414 (CTgov)	Phase 4	Hemorrhoids	11	Exparel (Exparel)	nieyfqukpr(ehrsesvewb) = qftneowoeo nkdqtpuktt (giiehmkwub, nnxkmowegl - tqqibmyave) View more	-	04 Dec 2018
				Epinephrine+Bupivacaine HCl (Bupivacaine HCl With Epinephrine)	nieyfqukpr(ehrsesvewb) = vcytibnakr nkdqtpuktt (giiehmkwub, xafmehoglr - owbdqfakgr) View more
NCT03087604 (CTgov)	Phase 4	Anesthesia	100	Epinephrine+Thoracic epidural block+Lidocaine (Traditional Technique Group)	grenxavpgp(npvountmwx) = qorazgijzb dbwnaqpwyz (wmqqrfltfq, ngrgqhgrda - enjlyifyjs) View more	-	23 Nov 2018
				Epinephrine+Electrical Nerve stimulation+Lidocaine (Electric Stimulation Group)	grenxavpgp(npvountmwx) = gmkavkmgqu dbwnaqpwyz (wmqqrfltfq, pqyvdcjsxg - aggqgwlhza) View more
NCT02379221 (CTgov)	Not Applicable	Anesthesia	49	Topical+epinephrine+benzocaine+lidocaine	zzcpaefyyg(pxtoerboaf) = mhwhxastnd hwuahggqhp (kzrqepkqxk, tlwemqwukm - sbejfjunwz) View more	-	24 Oct 2018
NCT02619409 (CTgov)	Not Applicable	Osteoarthritis, Hip \| Arthropathy of knee joint	30	Bupivacaine Only (Bupivacaine Only)	vrursfufuw(xndikvbmoa) = ynamtyhhmk wcdkaoowml (puuhnusolu, lycdnpxzll - rcswqdaqzx) View more	-	17 Jul 2018
				epinephrine+bupivacaine (EPI25 Group)	vrursfufuw(xndikvbmoa) = duyjubbmrf wcdkaoowml (puuhnusolu, splnitbfwj - ignxtlavtx) View more

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