A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Neurological Effects of EryDex in Subjects With Ataxia Telangiectasia (NEAT)

This is an international, multi-center, randomized, prospective, double-blind, placebo-controlled, Phase 3 study, designed to assess the effect of EryDex (dexamethasone sodium phosphate [DSP] in autologous erythrocytes), administered by intravenous (IV) infusion once every 28 days, on neurological symptoms of patients with Ataxia Telangectasia (A-T).

Start Date01 Jun 2024

Sponsor / Collaborator

Biotrial Research SAS

NCT06330519 / CompletedPhase 4IIT

"Impact of Different Techniques on the Efficacy of Anaesthesia in Mandibular Molars With Acute Irreversible Pulpitis: A Randomized Controlled Trial"

The goal of this clinical trial is to assess the effect of
Preoperative intraligamentary corticosteroids injection
Cryotherapy which is cold application on :
Hard tooth structure ( crown of the tooth )
Soft tissue overlying roots on the efficacy of the inferior alveolar nerve block anaesthesia in patients with mandibular molars with symptomatic irreversible pulpitis. The main question it aims to answer are: • Does intraligamentary dexamethazone injection increase the success rate of inferior alveolar nerve block without the need for oral premedication.
Participants will describe their preoperative pain level to the investigator and describe their pain level during the treatment.
Researchers will compare cryotherapy to see if it increases the success rate of inferior alveolar nerve block.

Start Date25 Sep 2023

Sponsor / Collaborator

Ain Shams University

NCT05736549 / RecruitingPhase 2IIT

Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2

The objective of this study is to investigate the efficacy of Dexamethasone sodium phosphate plus Methylprednisolone acetate in combination with plain bupivacaine ((B-DEX-MPA) compared with Liposomal Bupivacaine in combination with plain bupivacaine (B-LB) on post-surgical pain control among patients undergoing bilateral total knee arthroplasty (TKA) to asses if perineural B-DEX-MPA will result in superior analgesia efficacy as compared to B-LB.
This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.

Start Date07 Feb 2023

Sponsor / Collaborator

Yale University

100 Clinical Results associated with Dexamethasone Sodium Phosphate

100 Translational Medicine associated with Dexamethasone Sodium Phosphate

100 Patents (Medical) associated with Dexamethasone Sodium Phosphate

1,066

Literatures (Medical) associated with Dexamethasone Sodium Phosphate

02 Feb 2024·Medicine

A case report: Nonsecretory multiple myeloma presenting with bone pain

Article

Author: Geng, Qianshuang ; Li, Xi ; Liang, Li ; Zhang, Guoxiang ; Ge, Li ; Zhang, Wenjie ; Li, Jie

Rationale::

Nonsecretory multiple myeloma (NSMM) is a rare subtype of multiple myelom, occurring in 1% to 2% of multiple myelom and characterized by the inability of clonal plasma cells to synthesize or secrete immunoglobulins. We describe a 71-year-old male patient who began with bone pain and was referred to hospital several times, but was not properly diagnosed and effectively treated.

Patient concerns::

A 71-year-old male patient visited our hematology department, complaining of lumbago for 1 year and back pain for half a year.

Diagnoses::

Low-dose whole-body bone computed tomography: multiple bone destruction of the sternum, ribs, multiple vertebrae and accessories of the spine, pelvis, bilateral humerus, and proximal femur. Monoclonal plasma cells accounted for 17.5% of nuclear cells in bone marrow puncture smear. Fluorescence in situ hybridization detected amplification of CKS1B (1q21) gene. Immunofixation electrophoresis negative. About 10.72% of monoclonal plasma cells were detected by flow cytometry. Finally, he was diagnosed with NSMM.

Interventions::

The patients received VCD chemotherapy (bortezomib 1.3 mg/m2, d1, d4, d8, d11; cyclophosphamide 300 mg/m2, d1–2, d8–9; dexamethasone sodium phosphate 20 mg, d1–2, d4–5, d8–9, d11–12, once every 21 days).

Outcomes::

After 2 cycles of VCD treatment, the symptoms of bone pain were significantly relieved, and the efficacy was evaluated as partial response. Follow-up chemotherapy will continue to be completed on schedule. We will continue to follow up to further evaluate the overall survival and progression-free survival.

Lessons::

This case shows that NSMM is easily missed or misdiagnosed.

01 Feb 2024·Indian journal of ophthalmology

Subconjunctival dexamethasone-assisted conjunctival autograft harvesting versus normal saline during pterygium surgery – A randomized clinical trial

Article

Author: Meena, Ashok ; Gurnani, Bharat ; Agrawal, Ashish ; Parmar, Gautam

Purpose::

To evaluate the effect of subconjunctival dexamethasone compared to normal saline on conjunctival autograft harvesting in patients undergoing pterygium surgery.

Methods::

Fifty-two eyes of 52 patients who underwent pterygium excision combined with autologous conjunctival graft (CAG) using releasable suture were included in this prospective interventional study. The patients were randomized into two groups of 26 patients each. Group A consisted of patients in whom CAG was harvested using subconjunctival 0.5 ml of 0.4% dexamethasone sodium phosphate and in group B patients, normal saline was used. The patients were assessed for postoperative pain, foreign body sensation, and watering as the subjective signs of inflammation and conjunctival inflammation and lid edema as the objective signs of inflammation at 12 and 24 h postsurgery.

Results::

The mean age of group A and B patients was 47.69 + 13.09 and 46.00 + 10.76 years, respectively. The male:female ratio was 1.6:1 in group A and 1.1:1 in group B. The mean surgical time in group A was 243.96 ± 52.13 s and in group B was 258.08 ± 43.99 s. Postoperative pain, foreign body sensation, and watering were significantly lower in group A patients than in group B patients at both 12 and 24 h postoperatively (group A: 4.65 ± 1.33, 4.88 ± 1.73, and 3.85 ± 1.43, respectively, at 12 h; 1.89 ± 1.03, 1.69 ± 1.09, and 1.69 ± 0.97, respectively, at 24 h and group B: 6.42 ± 0.95, 6.65 ± 0.98, and 6.27 ± 1.40, respectively, at 12 h; 3.27 ± 1.43, 3.12 ± 1.25, 2.58 ± 1.14, respectively, at 24 h) (P < 0.001). Conjunctival inflammation was significantly lower in group A at 12 h (P < 0.05) and 24 h (P < 0.05) after surgery compared to group B. Lid edema failed to show any significant (P = 0.17) difference with respect to severity in both the groups at 12 and 24 h (P = 0.699).

Conclusion::

Subconjunctival dexamethasone decreased patient discomfort following pterygium surgery. The dexamethasone group had reduced conjunctival inflammatory signs without any notable complications.

01 Jan 2024·BMJ open

Randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3): study protocol

Article

Author: Stock, Sarah Jane ; Bick, Debra ; Norrie, John ; Townsend, Rosie C ; Norman, Jane E ; Fenwick, Natasha ; Reynolds, Rebecca ; Keerie, Catriona ; Khalil, Asma ; Boardman, James P ; Reed, Keith ; Luyt, Karen ; Thompson, Jessica ; Denton, Jane ; Boyd, Kathleen Anne ; Murray, Sarah ; Deidda, Manuela

Introduction:

The aim of the STOPPIT-3 study is to determine the clinical and cost effectiveness of antenatal corticosteroids (ACS) prior to planned birth of twins in a multicentre placebo-controlled trial with internal pilot.

Methods and analysis:

This study will comprise a multicentre, double-blinded, randomised, placebo-controlled trial in at least 50 UK obstetric units. The target population is 1552 women with a twin pregnancy and a planned birth between 35 and 38+6 weeks’ gestation recruited from antenatal clinics. Women will be randomised to Dexamethasone Phosphate (24 mg) or saline administered via two intramuscular injections 24 hours apart, 24–120 hours prior to scheduled birth.

Outcomes:

The primary outcome is need for respiratory support within 72 hours of birth. Secondary and safety outcomes will be included. Cognitive and language development at age 2 years will be assessed in a subset of participants using the Parent report of Children’s Abilities-Revised questionnaire. We will also determine the cost effectiveness of the treatment with ACS compared with placebo.

Ethics and dissemination:

STOPPIT-3 has been funded and approved by the National Institute of Healthcare Research. It has been approved by the West Midlands Research Ethics Committee (22/WM/0018). The results will be disseminated via publication in peer-reviewed journals and conference presentation and will also be communicated to the public via links with charity partners and social media.

Trial sponsor:

The University of Edinburgh and Lothian Health Board ACCORD, The Queen’s Medical Research Institute, 47 Little France Crescent, Edinburgh, EH16 4TJ.

Trial registration number:

ISRCTN59959611.

165

News (Medical) associated with Dexamethasone Sodium Phosphate

25 Jun 2024

·www.biospace.com

Quince Therapeutics Announces First Patient Dosed in Phase 3 Clinical Trial of EryDex for the Treatment of Ataxia-Telangiectasia

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug delivery technology designed to leverage a patient’s own biology to deliver rare disease therapeutics, today announced that the first patient has been dosed in the company’s Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T) clinical trial to evaluate the neurological effects of EryDex in patients with Ataxia-Telangiectasia (A-T). This pivotal Phase 3 study will be conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food & Drug Administration (FDA). “The initiation of our pivotal Phase 3 NEAT study is a major milestone for Quince, and an opportunity for patients living with the devastating effects of Ataxia-Telangiectasia to participate in research seeking to identify a beneficial therapeutic solution,” said Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer. “There are currently no approved therapeutic treatments in any global market for this rare pediatric disease, and our primary corporate objective is to change that for patients with A-T and their families.” The Phase 3 NEAT clinical trial (#IEDAT-04-2022/NCT06193200) is an international, multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of EryDex in patients with A-T. The study plans to enroll approximately 86 patients with A-T ages six to nine years old (primary analysis population) and approximately 20 patients with A-T ages 10 years or older. Participants will be randomized (1:1) between EryDex or placebo and treatment will consist of six infusions scheduled every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last visit completion in rescored modified International Cooperative Ataxia Rating Scale (RmICARS). Participants who complete the full treatment period, complete the study assessments, and provide informed consent will be eligible to transition to an open label extension (OLE) study. Quince expects to report Phase 3 NEAT topline results in the second half of 2025 with a potential New Drug Application (NDA) submission in 2026, assuming positive study results. With the achievement of the first patient enrolled in this study, Quince will make a cash milestone payment of $5 million to the former EryDel shareholders. The company owes no further development related milestones to EryDel shareholders. About Ataxia-Telangiectasia A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder caused by mutations in the ATM gene, which is responsible for cell homeostatic and cell division functions including but not limited to double-stranded DNA repair. Typically, A-T is first diagnosed before the age of five as children begin to develop an altered gait and fall with greater frequency. Neurological symptoms worsen and patients with A-T frequently become wheelchair-bound by adolescence. Teenage years for patients with A-T are typically marked by repeated infections, pulmonary impairment, and malignancies. The median lifespan is approximately 25 to 30 years old with mortality due to infections and malignancy. Based on IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics information, there are approximately 4,600 diagnosed patients with A-T in the U.S. Quince estimates that there are approximately 5,000 patients with A-T in the U.K. and EU4 countries. There are currently no approved therapeutic treatments in any global market for A-T. About EryDex for A-T EryDex is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient’s own red blood cells. DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. EryDex is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment. EryDex leverages Quince’s proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient’s own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince’s AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response. About Quince Therapeutics Quince Therapeutics (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the potential of a patient’s own biology to deliver innovative and life-changing therapeutics to those living with rare diseases. For more information on the company and its latest news, visit and follow Quince Therapeutics on social media platforms LinkedIn, Facebook, and Twitter/X. Forward-looking Statements Statements in this news release contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as “believe,” “may,” “should,” “expect,” “anticipate,” “plan,” “believe,” “estimated,” “potential,” “intend,” “will,” “can,” “seek,” or other similar words. Examples of forward-looking statements include, among others, statements relating to current and future clinical development of EryDex, including a pivotal trial for Ataxia-Telangiectasia, potential commercial-stage inflection point for EryDex, and expansion of the company’s proprietary Autologous Intracellular Drug Encapsulation (AIDE) technology for treatment of other rare diseases; the strategic development path for EryDex; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; the timing and success of the clinical trials and related data, including plans and the ability to initiate, conduct, and/or complete current and additional studies; the company’s future development plans and related timing; the company’s focus, objectives, plans, and strategies; and the company’s market opportunity. Forward-looking statements are based on Quince’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled “Risk Factors” in the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on April 1, 2024, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law.

Phase 3

24 Jun 2024

·www.globenewswire.com

Helsinn Group announces AKYNZEO® (fosnetupitant/palonosetron) injection is now available in a ready-to-use vial in the US

Helsinn Group announces AKYNZEO® (fosnetupitant/palonosetron) injection is now available in a ready-to-use vial in the US Lugano, Switzerland – June 24, 2024 – Helsinn Group (“Helsinn”), a global pharmaceutical company with a track record of over forty-five years of commercial execution and a strong focus in supportive care, oncology and dermato-oncology, is pleased to announce that AKYNZEO® (fosnetupitant/palonosetron) injection is now available in the US in a ready-to-use vial. AKYNZEO injection (Ready-to-Use) is a new method of administration and contains the same formulation as the prior AKYNZEO Injection (To-be-Diluted). The features of the new ready-to-use presentation of AKYNZEO injection include: No reconstitution or dilution required; infuse directly from the vial using a built-in hanging strapNo refrigeration required at any point during distribution, storage, or preparationAccessible via automated dispensing machine, allowing the product to be stored and available near the location of patient care AKYNZEO injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. It has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO injection does not contain polysorbate 80 or allergenic excipients such as soy or egg lecithin. It can be administered simultaneously with intravenous dexamethasone sodium phosphate. Dr. Melanie Rolli, Helsinn Group CEO, commented: “As a pioneer in cancer supportive care, Helsinn continues to be unwavering in our pursuit to help patients and clinicians in cancer care. We are very pleased to launch the new AKYNZEO Ready-to-Use vial, building on our legacy of innovation.” Ordering information Clinicians wishing to order the new vial should contact their GPO or distributor. The National Drug Code (NDC) number for AKYNZEO injection vial with hanger (Ready-to-Use) is 69639-106-01 and the J Code is J1454 (Injection, fosnetupitant 235 mg and palonosetron 0.25 mg); billing unit (single dose vial [SDV]). About AKYNZEO® AKYNZEO is the first and only 5-HT3 and NK1 receptor antagonists fixed combination approved for the prevention of chemotherapy-induced acute and delayed nausea and vomiting. A single dose of AKYNZEO given with dexamethasone has been shown to prevent chemotherapy-induced nausea and vomiting for up to 5 days. INDICATION AKYNZEO (fosnetupitant/palonosetron) injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Limitations of Use AKYNZEO injection has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO is a combination of palonosetron, a serotonin-3 (5-HT3) receptor antagonist, and fosnetupitant, a substance P/neurokinin-1 (NK-1) receptor antagonist: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. IMPORTANT SAFETY INFORMATION Warnings and Precautions Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron, one of the components of AKYNZEO, with or without known hypersensitivity to other 5-HT3 receptor antagonists.Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue AKYNZEO and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if AKYNZEO is used concomitantly with other serotonergic drugs. Adverse Reactions Most common adverse reactions (≥3%) for AKYNZEO capsules are headache, asthenia, dyspepsia, fatigue, constipation and erythema. The safety profile of AKYNZEO injection was generally similar to AKYNZEO capsules. Drug Interactions Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with AKYNZEO. The inhibitory effect on CYP3A4 can last for multiple days Dexamethasone doses should be reduced when given with AKYNZEO. A more than two- fold increase in the systemic exposure of dexamethasone was observed 4 days after a single infusion of fosnetupitant.Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO. When administered with netupitant, the systemic exposure to midazolam was significantly increased. Avoid concomitant use of AKYNZEO in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of AKYNZEO. Use in Specific Populations Avoid use of AKYNZEO in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease.Advise women of potential risk to fetus; limited data are available; may cause fetal harm. For more information about AKYNZEO® please see the full US Prescribing Information. About Helsinn Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic disease, with a focus on supportive care, oncology and dermato-oncology. Helsinn, headquartered in Lugano, Switzerland, has direct commercial operations in the U.S. and an extensive network of long-standing trusted partners enabling a commercial presence in more than 90 countries. Established in 1976, Helsinn is a third-generation family-owned company with broad pharmaceutical and technical expertise. Helsinn is proud of its history of operating with great integrity, passion and quality. The company is committed to continuously striving for innovation for its patients and embracing sustainable growth as a core element of its strategic vision. To learn more about Helsinn, please visit www.helsinn.com or follow us on LinkedIn and X. For more information: Helsinn Group Media Contact:Sabrina PerucchiGroup Communication ManagerLugano, Switzerland Tel: +41 (0) 91 985 21 21 Email: Info-hhc@helsinn.com

Drug ApprovalClinical Result

20 Jun 2024

·www.globenewswire.com

Scilex Holding Company Partners with New National Distributor, Endeavor Distribution LLC.

PALO ALTO, Calif., June 20, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that in anticipation of selling our commercially available products to new and current special customers, Scilex has entered into a non-exclusive distribution agreement with a well-known and highly respected distributor with over 10 years of sales excellence, Endeavor Distribution LLC. (“Endeavor”). Endeavor has logistics expertise to sell and distribute our currently marketed non-opioid products nationally. Endeavor is an Oklahoma-owned and operated company committed to top-notch logistics and distribution service. They have been involved in logistics, warehousing, manufacturing, fulfillment center preparation, and customer service for over 10 years and will be leveraging that experience to provide our clients the best pick and pack fulfillment and other warehouse and distribution services. “The commercialization of Scilex’s three non-opioid products continues on schedule and we anticipate growth to accelerate through this year and beyond 2024. Given our accelerated pace of product growth, we are aggressively implementing our strategy of building out additional logistics and distribution for our commercial products. Signing an additional distribution partner at this point sets the stage for a successful and aggressive product launch into specialized point of care customers. We will continue to carefully refine our launch strategy and selectively add distribution partners who serve our shared customers with excellence,” said Jaisim Shah, CEO and President of Scilex. For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA™” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022. Scilex Holding Company is headquartered in Palo Alto, California. Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding new distributor agreement, the exploration of potential transactions involving Semnur, the expectation that any such transactions would be available and able to be completed, the expectation that any such potential transaction will maximize the value of Semnur and SP-102 for Scilex and its stockholders, Scilex’s expectation that SP-102’s Phase 3 study represents a potential significant improvement in treatment of adult patients with lumbosacral radicular pain (sciatica), statements regarding SP-102 (SEMDEXA™), if approved by the FDA, including the potential market and demand of SP-102 (SEMDEXA™), Scilex’s expectation that SP-102 (SEMDEXA™) would be an important addition to treatment options for patients with lumbosacral radicular pain and Scilex’s development and commercialization plans. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks associated with Scilex’s ability to engage in any potential transaction involving Semnur and SP-102, including the ability to conduct a spin-off, merger, dividend, reclassification or other similar transaction; risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to Scilex Holding Company to use the registered trademark. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2024 Scilex Holding Company All Rights Reserved.

Fast TrackPhase 3Drug ApprovalPhase 1Phase 2

100 Deals associated with Dexamethasone Sodium Phosphate

External Link

KEGG	Wiki	ATC	Drug Bank
D00975	Dexamethasone Sodium Phosphate	D07AB19 H02AB02 D10AA03	DB01234

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Lung Diseases	JP	Fuji Pharma Co., Ltd.	26 Jun 2009
Nephrosis	JP	Fuji Pharma Co., Ltd.	26 Jun 2009
Tuberculosis	JP	Fuji Pharma Co., Ltd.	26 Jun 2009
Nausea and vomiting	JP	Sandoz AG	15 Sep 2005
Nausea and vomiting	JP	Fuji Pharma Co., Ltd.	15 Sep 2005
Multiple Myeloma	JP	Sandoz AG	14 Feb 2005
Multiple Myeloma	JP	Fuji Pharma Co., Ltd.	14 Feb 2005
Hypersensitivity	CN	Yichang Sanxia Pharmaceutical Co., Ltd.	01 Jan 1981
Inflammation	CN	Yichang Sanxia Pharmaceutical Co., Ltd.	01 Jan 1981
Anaphylaxis	US	Aspen Global, Inc.	04 Dec 1964
Edema	US	Aspen Global, Inc.	04 Dec 1964
Endocrine System Diseases	US	Aspen Global, Inc.	04 Dec 1964
Eye Diseases	US	Aspen Global, Inc.	04 Dec 1964
Gastrointestinal Diseases	US	Aspen Global, Inc.	04 Dec 1964
Leukemia	US	Aspen Global, Inc.	04 Dec 1964
Lymphoma	US	Aspen Global, Inc.	04 Dec 1964
Multiple Sclerosis	US	Aspen Global, Inc.	04 Dec 1964
Respiratory Diseases	US	Aspen Global, Inc.	04 Dec 1964
Rheumatic Heart Disease	US	Aspen Global, Inc.	04 Dec 1964
Skin Diseases	US	Aspen Global, Inc.	04 Dec 1964

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis, Knee	Phase 3	US	TLC BioSciences	26 Nov 2019
Osteoarthritis, Knee	Phase 3	AU	TLC BioSciences	26 Nov 2019
Osteoarthritis, Knee	Phase 3	AU	Taiwan Liposome Co., Ltd.	26 Nov 2019
Ataxia Telangiectasia	Phase 3	US	EryDel SpA	12 Jun 2018
Ataxia Telangiectasia	Phase 3	AU	EryDel SpA	12 Jun 2018
Ataxia Telangiectasia	Phase 3	BE	EryDel SpA	12 Jun 2018
Ataxia Telangiectasia	Phase 3	DE	EryDel SpA	12 Jun 2018
Ataxia Telangiectasia	Phase 3	IN	EryDel SpA	12 Jun 2018
Ataxia Telangiectasia	Phase 3	IT	EryDel SpA	12 Jun 2018
Ataxia Telangiectasia	Phase 3	PL	EryDel SpA	12 Jun 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04544683 (CTgov)	Phase 4	Radiculopathy \| Intervertebral Disc Displacement \| Radicular Pain ... View more	33	Cervical Transforaminal Epidural Injection	pzecwfmjtc(kxplmeulwb) = ymfwdqlaoc iwfoixctwa (fxytpqiwzn, vyfnmfvsna - ocxxyfrqzw) View more	-	10 Apr 2024
NCT03606980 (CTgov)	Phase 2	Juvenile apophysitis	45	Physical Therapy+Dexamethasone Sodium Phosphate (Iontophoresis With Dexamethasone)	njmzozmgjl(bgbnfxnoma) = cgibeetmer gpsrjagctl (mrxvkytjgg, dbsfhqjvmf - zlsvveepjf) View more	-	06 Mar 2024
				Physical Therapy (Iontophoresis With Sodium Chloride)	njmzozmgjl(bgbnfxnoma) = vinrblnxxq gpsrjagctl (mrxvkytjgg, pqraqppohw - ppptykrvhe) View more
NCT04123561 (EXCELLENCE, ACR2023) Manual	Phase 3	Osteoarthritis, Knee	506	TLC599 12 mg	renivufddh(myfrgnvlrz): P-Value = <0.05	Positive	24 Oct 2023
				DSP 4 mg
NCT02192827 (CTgov)	Phase 3	Childhood asthma	318	Dexamethasone Sodium Phosphate Injection (Single Dose Dexamethasone)	mtjvbkjbmo(curgdgtehy) = ydpjnpanrh mclhharezk (gcutuvrtnx, dpfumudeeh - zzeqqsnwdn) View more	-	30 Mar 2023
				Dexamethasone Sodium Phosphate Injection (Two Dose Dexamethasone)	mtjvbkjbmo(curgdgtehy) = zijxwsapzm mclhharezk (gcutuvrtnx, rcjbkmjeun - jthxvdaekh) View more
NCT03372161 (CTgov)	Phase 3	Radicular Pain \| Intervertebral Disc Disease	401	SP-102 (SP-102)	sqoqqumzvs(yoszytxlkp) = uaymxgphra buanxyctpt (remdaeovvw, chkqoegvqq - xekielwuab) View more	-	19 Sep 2022
				Placebo (Placebo)	sqoqqumzvs(yoszytxlkp) = nszvowaxjw buanxyctpt (remdaeovvw, ovqsffpnpp - vyldnqscur) View more
PCT/US21/19773 (ASCO2022)	Not Applicable	Solid tumor \| Hematologic Neoplasms	-	AVM0703 monotherapy	ivqbjcgmrl(qcdpbwcvam) = izmnczgnsa bpoaafieua (fwcipjlhdo )	-	02 Jun 2022
				AVM0703 preconditioning prior to adoptive cell transfer	ivqbjcgmrl(qcdpbwcvam) = nyxeqcznfm bpoaafieua (fwcipjlhdo )
NCT02803307 (CTgov)	Phase 1/2	Osteoarthritis, Knee	40	TLC599 (6 mg TLC599)	eptufmqipd(ygtxbwgffr) = nazlkgvqje unllzeftvv (jdykuugyoa, paefcnpdqn - bmlgbfuvuu) View more	-	06 May 2022
				TLC599 (12 mg TLC599)	eptufmqipd(ygtxbwgffr) = iiyhwktzek unllzeftvv (jdykuugyoa, nsftntwpho - osbwgppgay) View more
NCT03005873 (Pubmed \| Arthritis Res Ther) Manual	Phase 2	Osteoarthritis, Knee	75	TLC599	lntxpujenv(bzotrdkcdy): difference = -0.37, P-Value = 0.0027 View more	Positive	21 Feb 2022
				Placebo
NCT03613662 (CTgov)	Phase 2	Lumbosacral Radiculopathy \| Radicular Pain	19	SP-102	nitrrydzkv(umxocpacab) = gkzbmhokok ivwjtscboe (culjzvmlie, nubdmgjsdz - qiixhfpgit) View more	-	13 Jan 2022
NCT02006147 (CTgov)	Phase 1/2	Retinal vein occlusion-related macular edema	14	TLC399 (TLC399 (Group 1))	twuetqnxtk(qvyoywotcp) = saxgnqbdic xnuojlgdjt (wngjghznul, pehurlghzd - dfarpljjqz) View more	-	23 Dec 2021
				TLC399 (TLC399 (Group R1))	twuetqnxtk(qvyoywotcp) = dbnhtvhhne xnuojlgdjt (wngjghznul, huluwqdsmj - jslsveoevt) View more

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