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Last update 01 Aug 2025

Naloxone hydrochloride

Last update 01 Aug 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryNaloxone is a small molecule drug that acts as an antagonist at the μ opioid receptor, making it a potent tool in the treatment of opiate and drug overdose. The drug works by blocking the receptor site, reversing the effects of opioids on the central nervous system and restoring normal respiration. Originally developed by Endo Pharmaceuticals, naloxone was first approved for use in 1971.

Drug Type

Small molecule drug

Synonyms

Naloxone, Naloxone hydrochloride (JP17/USP), Naloxone hydrochloride dihydrate

+ [46]

Target

μ opioid receptor

Action

antagonists

Mechanism

μ opioid receptor antagonists(Mu opioid receptor antagonists)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Acute Lymphoblastic LeukemiaOpiate OverdoseOpioid abuse

Inactive Indication-

Originator Organization

Endo Pharmaceuticals, Inc.

Bexson Biomedical, Inc.

Active Organization

Hikma Pharmaceuticals LLCHikma Pharmaceuticals USA, Inc.

Mundipharma International Ltd.

+ [9]

Inactive Organization

Emergent Devices, Inc.

Summit Biosciences, Inc.

Nasus Pharma Ltd.

+ [2]

License Organization

Summit Biosciences, Inc.ZMI Pharma, Inc.

Harm Reduction Therapeutics, Inc.

+ [10]

Drug Highest PhaseApproved

First Approval Date

United States (13 Apr 1971),

Opiate Overdose

RegulationPriority Review (United States), Fast Track (United States), Orphan Drug (European Union)

Structure/Sequence

Molecular FormulaC19H22ClNO4

InChIKeyRGPDIGOSVORSAK-STHHAXOLSA-N

CAS Registry357-08-4

210

Clinical Trials associated with Naloxone hydrochloride

NCT06251609

/ Not yet recruitingPhase 2IIT

Naloxone for Opioid Associated Out of Hospital Cardiac Arrest

The investigator's long-term goal is to conduct Naloxone for Opioid Associated out of Hospital Cardiac Arrest (NOPACA), a randomized, double blind, controlled trial to determine the efficacy of naloxone vs. placebo in Opioid Associated out of Hospital Cardiac Arrest. The investigative team plan to randomize patients in OHCA to early naloxone administration vs. placebo after initial resuscitation and measure ROSC and survival. Challenges to designing NOPACA include uncertainty regarding: 1) the available pool of participants and number of EMS agencies needed to meet enrollment targets; 2) acceptability among patients, EMS and Emergency Medicine provider stakeholders, and 3) estimates of the study outcomes needed for sample size estimates. Toward obtaining the necessary information to design NOPACA, the investigators propose a pilot RCT of participants at high risk for OA-OHCA to verify a reasonable recruitment rate; treatment fidelity and acceptability; and adequate retention and measurement of outcomes at follow up. The investigators propose incorporating hypothesis testing of the feasibility outcomes to determine progression to a definitive trial.

Start Date01 Nov 2026

Sponsor / Collaborator

The University of California, San Francisco

NCT07079241

/ Not yet recruitingNot Applicable

REgion Sk?ne Preventing Overdose Through Naloxone Distribution With Emergency Runners: a Feasibility Study for a Model to Save Lives Through a Volunteer First Responder Service Providing Antidote Treatment in Opioid Overdose

Opioids are responsible for the greatest drug-related global health burden. Prevention and treatment programs for people with opioid use disorder are widely implemented, but further actions are required to reduce the mortality and morbidity caused by opioid use and dependence. We suggest a novel and unique approach with a volunteer first responder system for suspected opioid overdoses, integrated with national emergency call services. The idea derives from the success of volunteer first responder systems for out-of-hospital cardiac arrests. Several reports exist globally with results of increased survival rates, less complications and a beneficial time-gain to start of cardiopulmonary resuscitation before emergency services (like ambulance and fire fighters) arrival.
Our model aims to investigate feasibility, acceptability and safety of a smartphone-based volunteer first responder system for suspected opioid overdoses. The volunteer responders will be equipped with an emergency kit including two doses of the opioid antidote naloxone, which can reverse life-threatening respiratory arrest caused by intoxication of opioids. The responders will, prior to registration, accomplish an in-depth overdose and naloxone education, as well as a first aid course aligned with current European and Swedish resuscitation guidelines. The results will be collected through questionnaires to the responder participants, technical data from the responder application, and dispatcher, pre-medical/paramedical and hospital records among others. Both quantitative and qualitative methods will be used. The major question is if the model is feasible in alerting lay persons with naloxone to suspected overdose situations and successfully administer naloxone prior to emergency service arrival. Furthermore, experiences of safety during alerts among volunteer first responders and overdose victims will also be studied.
Our model is unique in its integration with emergency medical dispatch service along with overdose and first aid education prior to participant registration. The respiratory arrest of opioids is an acute life-threatening condition, which - in similarity to cardiac arrests - need emergent actions for survival. A reduced time to naloxone administration through volunteer first responders prior to ambulance arrival could save lives.

Start Date01 Sep 2025

Sponsor / Collaborator

Region Skåne Holding AB

[+3]

NCT04650841

/ Not yet recruitingEarly Phase 1IIT

The Role of the Opioid System in Placebo Effects on Pain and Social Rejection

The current study probes the involvement of the opioid system in placebo effects on social pain, using the opioid antagonist naloxone. 60 participants who recently experienced an unwanted breakup will experience rejection-related stimuli and receive painful heat and pressure stimuli during fMRI scanning. Participants will be randomized to receive either a naloxone or saline nasal spray, and be informed that the spray is either saline, or an effective pain and negative emotion reducing agent.

Start Date01 Sep 2025

Sponsor / Collaborator

Trustees of Dartmouth College

100 Clinical Results associated with Naloxone hydrochloride

100 Translational Medicine associated with Naloxone hydrochloride

100 Patents (Medical) associated with Naloxone hydrochloride

30,841

Literatures (Medical) associated with Naloxone hydrochloride

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Hailey-Hailey disease successfully treated with naloxone: 2 case reports and Review of the literature on efficacy of opioid receptor antagonist in Hailey-Hailey disease patients

Review

Author: Sheng, Nan ; Wu, Jianbing ; Fang, Fang ; Duan, Zhimin ; Xu, Beilei ; Li, Chengrang ; Song, Hao ; Zheng, Junyou

BACKGROUND:

Hailey-Hailey disease (HHD), a genetic blistering disease, is caused by a mutation in a calcium transporter protein in the Golgi apparatus encoded by the ATP2C1 gene. Clinically, HHD is characterized by flaccid vesicles, blisters, erosions, fissures, and maceration mainly in intertriginous regions. Some patients remain refractory to conventional treatments. Previously, a series of reports have confirmed naltrexone as an effective option for those patients. However, in China, naltrexone is unavailable in some hospitals and unaffordable for some patients.

OBJECTIVE:

To confirm naloxone as a treatment option for HHD, and assess the efficacy rate and safety of naltrexone for patients with HHD.

METHODS:

Two patients with biopsy-proven HHD received naloxone (2 mg/d, via intravenous infusion). We followed up with the two patients, assessing the change of skin lesions and obtaining photographs. We searched the PubMed databases using the keywords 'Hailey-Hailey disease' or 'benign familial pemphigus', and 'naltrexone' or 'naloxone', and reviewed English publications of reports and analyzed the efficacy and safety of naltrexone.

RESULTS:

Two patients prescribed naloxone showed completely remission in two weeks without any adverse reactions. The total remission rate of naltrexone for HHD is approximately 80%, without severe adverse effects.

CONCLUSION:

Naltrexone is effective and safe in the treatment of HHD. Naloxone, an analog of naltrexone, can also effectively and safely treat HHD, potentially offering a new therapeutic option for patients with refractory HHD.

31 Dec 2025·Future Science OA

Evaluating cytidine, uridine, and gabapentin combinations for pain modulation and p-CREB expression in neuropathic model

Article

Author: Alzaghari, Lujain F. ; Qnais, Esam Y. ; Barakat, Muna ; Al-Najjar, Mohammad A. A. ; Chellappan, Dinesh Kumar ; Alqudah, Abdelrahim ; Athamneh, Rabaa Y.

AIMS:

To evaluate the analgesic and neuroprotective effects of cytidine, uridine, and gabapentin-administered alone and in combination-in models of diabetic neuropathy and formalin-induced acute and inflammatory pain.

MATERIALS & METHODS:

Oral doses of cytidine, uridine, and gabapentin (100 mg/kg each) were administered to rats with streptozotocin-induced diabetic neuropathy and in a formalin test model. Behavioral responses were recorded at 30, 60, and 120 minutes following treatment after five weeks of diabetes induction. Spinal cord p-CREB expression was measured to assess molecular changes, and pretreatments with naloxone, yohimbine, and methysergide were employed to explore opioid, adrenergic, and serotonergic contributions.

RESULTS:

All treatments significantly reduced formalin-induced pain in both acute and inflammatory phases (p < 0.05; p < 0.001) and increased mechanical pain thresholds in the diabetic neuropathy model at all-time points (p < 0.05). Combination therapy proved more effective than gabapentin alone (p < 0.05) and was associated with decreased spinal p-CREB levels, indicating altered anti-nociceptive signaling.

CONCLUSIONS:

The combined use of cytidine, uridine, and gabapentin enhances analgesia and neuroprotection compared to monotherapy, supporting its potential as a novel, analgesic-free treatment strategy for diabetic neuropathy.

01 Nov 2025·NEUROPHARMACOLOGY

Antibiotic treatment improves gut dysbiosis and depression-like behavior induced by morphine withdrawal

Article

Author: Gu, Bo-Yuan ; Liu, Jun-Lin ; Yu, Dong-Yu ; Zhang, Yu-Xiang ; Gao, Jing-Qi ; Yan, Chun-Xia ; Gao, Fei-Fei ; Shen, Meng-Qing ; Yang, Xi-Xi

Opioid withdrawal poses a significant neuropsychiatric challenge, notably contributing to the onset of depression. Depression intertwines with gut flora richness and diversity, frequently coinciding with synaptic plasticity alterations in the brain. Gut microbiota dysbiosis potentially contributes to withdrawal-triggered depression via gut-brain axis. This research delves into the impact of antibiotic-induced gut microbiota alteration on behavioral and synaptic protein variations in mice subjected to morphine withdrawal-induced depression. A murine model was established using escalating doses of morphine followed by naloxone-precipitated withdrawal. Depression-like behaviors were assessed through tail suspension, sucrose preference, forced swimming tests, while histopathology evaluated ileocolonic inflammation. Synaptic markers, Synaptophysin (SYP) and Synapsin 1 (SYN1), in the hippocampus were analyzed via Western blotting, and gut microbiota composition was assessed through 16S rRNA sequencing. An antibiotic intervention model was employed to explore microbiota-dependent mechanisms. Morphine withdrawal induced characteristic depression-like behaviors, including prolonged immobility in forced swimming and reduced sucrose preference. Microbiota diversity metrics demonstrated significant declines in α-diversity. Histological analysis revealed marked inflammatory infiltration in ileal tissues, accompanied by reduction in hippocampal SYP expression. Antibiotic administration attenuated behavioral impairments, mitigated gut dysbiosis, reduced intestinal inflammation, and partially rescued SYP expression. These findings establish that morphine withdrawal induces intestinal dysbiosis, hippocampal synaptic plasticity deficits and depression-like behaviors, which are reversible through microbiota modulation. The results highlight the antibiotic treatment as a potential therapy for opioid withdrawal sequelae.

510

News (Medical) associated with Naloxone hydrochloride

29 Jul 2025

·www.globenewswire.com

Branded Legacy, Inc. Signs Letter of Intent to Acquire Bio-Legacy Evaluative Group, Advancing Innovations in Intranasal Drug Delivery

Strategic Acquisition Positions Branded Legacy to Enter the Growing Naloxone and Vaccine Markets, Enhancing Shareholder Value; Leadership Transition Planned with Amin Janmohamed as New CEO and ChairmanMELBOURNE, Fla., July 29, 2025 (GLOBE NEWSWIRE) -- via IBN -- Branded Legacy, Inc. (OTC: BLEG), a diversified holdings company focused on innovative health and wellness solutions, today announced the execution of a non-binding Letter of Intent (LOI) to acquire Bio-Legacy Evaluative Group, a pioneering health innovation company specializing in advanced intranasal drug delivery technologies. The LOI, fully executed by both parties, outlines the proposed acquisition of 100% of Bio-Legacy Evaluative Group's equity interests, assets, intellectual property, and operations in exchange for $1.5 million worth of Branded Legacy's Preferred D stock. This strategic move aligns with Branded Legacy's commitment to expanding its portfolio into high-growth sectors addressing global health crises, such as addictions and vaccine accessibility. Bio-Legacy Evaluative Group, led by President & CEO Amin Janmohamed, has assembled a world-class team of experts including Prof. Eran Bendavid, MD (Research Lead, Stanford Professor), Prof. Sonal Singh, MD (Medical Lead, UMass Professor), Prof. Martin Schechter, MD, PhD (Scientific Advisor), and others renowned in addiction medicine, biostatistics, and business development. Bio-Legacy Evaluative Group's patented all-in-one intranasal naloxone delivery device addresses key limitations in the current market, including high costs, inconsistent dosing, and complex systems. By simplifying manufacturing and enhancing dose precision, the technology aims to make naloxone more accessible amid a projected market growth from $371 million in 2022 to over $1.16 billion by 2032, at a CAGR of approximately 11.9%. Additionally, Bio-Legacy Evaluative Group's platform enables nasal administration of compounds previously constrained by physical, chemical, or manufacturing challenges, opening new opportunities in vaccines, cold-chain dependent medications and medications unstable in solution. This could facilitate faster pandemic responses, self-use vaccination, and improved logistics for underserved regions globally. Under the terms of the LOI, the Preferred D stock issued as consideration will be subject to a two-year holding period and convertible only upon Bio-Legacy Evaluative Group achieving a $40 million post-acquisition valuation, as determined by an independent third-party firm. Branded Legacy has also committed to a $1 million research and development budget for Bio-Legacy Evaluative Group's initiatives, effective upon the company's uplisting to the OTCQB market tier and achieving a minimum share price of $0.01 per share. The parties intend to close the transaction within 14 days, subject to due diligence, definitive agreements, and necessary approvals. Upon completion, Bio-Legacy Evaluative Group will become a wholly-owned subsidiary of Branded Legacy, integrating its innovative pipeline—including manufacturing prototyping targeted for Q3 2025, clinical trials in 2026, and market readiness for the naloxone device by Q1 2027—to drive revenue growth. Projected revenues for Bio-Legacy Evaluative Group under average growth scenarios could reach up to $183.3 million by Year 5. Following the closing of the acquisition, Amin Janmohamed will assume the roles of CEO and Chairman of Branded Legacy, Inc., leveraging his experience as a pharmacist, clinical studies investigator, and executive to guide the combined entity's strategic direction. "We are thrilled to announce this LOI with Bio-Legacy Evaluative Group, a company at the forefront of tackling the escalating global addictions crisis through cutting-edge technology," said Robison, CEO of Branded Legacy, Inc. "This acquisition not only bolsters our health innovation capabilities but also positions us to capitalize on expanding markets like naloxone and intranasal vaccines, ultimately creating long-term value for our shareholders." Amin Janmohamed, CEO of Bio-Legacy Evaluative Group, added, "Partnering with Branded Legacy represents a significant milestone in our mission to make life-saving treatments more effective and accessible. Their resources and vision will accelerate our development timeline and help us reach patients worldwide who need these solutions most. I am excited to step into the role of CEO post-acquisition to lead this next phase of growth." The LOI includes standard provisions for exclusivity during negotiations and confidentiality. The transaction is expected to enhance Branded Legacy's competitive edge in the biotech and medical device sectors. For more information about Branded Legacy, Inc., visit www.brandedlegacy.com. About Branded Legacy, Inc. Branded Legacy, Inc. (OTC: BLEG) is a diversified holdings company dedicated to acquiring and growing innovative businesses in the health, wellness, and technology sectors. With a focus on strategic partnerships and shareholder value, Branded Legacy aims to deliver cutting-edge solutions that address real-world challenges. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and beliefs and involve risks and uncertainties that could cause actual results to differ materially. Branded Legacy undertakes no obligation to update these statements except as required by law. Investor Relations: Branded Legacy, Inc. Email: info@brandedlegacy.com Phone: 877-814-4188

Acquisition

28 Jul 2025

·www.prnewswire.com

Standard drug screening fails to identify some children who have been exposed to substances in unsafe home environments

New findings at ADLM 2025 could remedy this CHICAGO, July 28, 2025 /PRNewswire/ -- According to research presented today at ADLM 2025 (formerly the AACC Annual Scientific Meeting & Clinical Lab Expo), standard drug screening misses low concentrations of targeted substances in around 5% of urine samples taken from patients under age 18, suggesting that children with drugs in their systems are sometimes released from healthcare settings into unsafe home environments. The study highlights an adjustment that clinical labs can make to improve the accuracy of results and to help ensure that substance-exposed children and their families get appropriate support. Researchers have long known that standard urine drug screening (UDS) — which is typically done using a technique known as immunoassay — can sometimes trigger false positives, or erroneous results that indicate the presence of a drug when there isn't one. It's the reason a second confirmatory test with mass spectrometry is typically used to verify results for patients who test positive on immunoassay. However, the opposite issue, where UDS indicates an absence of drugs in patients who have actually taken them (false negatives), has not been well studied. This mistake is more likely to occur in samples taken from infants and young children whose kidneys are still developing or who have incidental exposure to a low level of drugs, resulting in a low drug concentration in their urine that may not reach the cutoff used in standard UDS. One approach for minimizing this possibility is to use mass spectrometry on all pediatric patients, skipping the initial immunoassay. "To our knowledge, St. Louis Children's is the only hospital in the U.S. to adopt this 'direct-to-mass-spectrometry' approach," said Dr. Yanchun Lin, one of the study's authors and a clinical chemistry fellow at Washington University in Saint Louis, Missouri. "So we really want to urge laboratorians to reconsider the approach they adopt for pediatric UDS testing." The researchers used two strategies to compare immunoassay results with mass spectrometry for detecting substances in common drug tests, including amphetamine/methamphetamine, cocaine/benzoylecgonine (the main metabolite of cocaine), THC, opiates, fentanyl, benzodiazepines, and methadone. In the first approach, they studied 125 urine samples over a 5-month period from pediatric patients with weakly positive results on mass spectrometry to check how many of them were missed by immunoassay (forward approach). For the second strategy, they assessed 115 urine samples that tested negative on immunoassay to assess if mass spectrometry could detect any drugs (reverse approach). Among the 125 samples that tested positive on mass spectrometry, 112 (approximately 90%) contained compounds not detected by immunoassay, most commonly methamphetamine and benzoylecgonine. Thirty-eight (33%) of the 115 samples found negative on routine UDS tested positive for at least one substance when re-examined by mass spectrometry. Moreover, mass spectrometry identified substances in six samples (5%) that were targeted but missed by immunoassay. In addition, the researchers identified 32 pediatric urine samples that contained prescription medications not picked up by immunoassay, including lorazepam, ketamine, bupropion, methylphenidate, clonidine, quetiapine, venlafaxine, and naloxone. They also found five samples containing fentanyl, which wasn't on the UDS menu at some study centers from which samples were taken. Taken together, the results indicate that UDS may miss low drug concentrations in approximately 1 in 20 pediatric urine samples. This finding held true using both the forward and reverse schemes, spanning multiple clinical environments and analytic platforms. Using a direct-to-mass spectrometry approach would significantly lessen the risk of false-negative drug screens and largely eliminate false-positive findings as well, the authors conclude. That said, making this change isn't without challenges for labs. "It's actually pretty labor intense," Lin said, "and it's much harder to maintain the assay" using the direct-to-mass spectrometry approach. "You need highly trained personnel and dedicated full-time employees," she added. But labs that can make the shift will benefit from more accurate results that could translate to better care. "If it's possible, it should definitely be adopted, especially for pediatric patients," Lin said. Session information ADLM 2025 registration is free for members of the media. Reporters can register online here: Abstract A-349: False-negative immunoassay drug screens uncovered with a direct to mass spectrometry approach in a pediatric population will be presented during: Student poster competition Monday, July 28 9:30 a.m. – 4 p.m. Room S405 Scientific poster session Tuesday, July 29 9:30 a.m. – 5 p.m. (presenting authors in attendance from 1:30 – 2:30 p.m.) Poster Hall on the Expo show floor Both sessions will take place at McCormick Place, Chicago. About ADLM 2025 ADLM 2025 (formerly the AACC Annual Scientific Meeting & Clinical Lab Expo) offers 5 days packed with opportunities to learn about exciting science from July 27-31 in Chicago. Plenary sessions will explore urgent problems related to clinical artificial intelligence (AI) integration, fake medical news, and the pervasiveness of plastics, as well as tapping into the promise of genomics and microbiome medicine for personalized healthcare. At the ADLM 2025 Clinical Lab Expo, more than 800 exhibitors will fill the show floor of the McCormick Place Convention Center in Chicago, with displays of the latest diagnostic technology, including but not limited to AI, point-of-care, and automation. About the Association for Diagnostics & Laboratory Medicine (ADLM) Dedicated to achieving better health for all through laboratory medicine, ADLM (formerly AACC) unites more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from 110 countries around the world. Our community is at the forefront of laboratory medicine's diverse subdisciplines, including clinical chemistry, molecular diagnostics, mass spectrometry, clinical microbiology, and data science, and is comprised of individuals holding the spectrum of lab-related professional degrees, certifications, and credentials. Since 1948, ADLM has championed the advancement of laboratory medicine by fostering scientific collaboration, knowledge sharing, and the development of innovative solutions that enhance health outcomes. For more information, visit . Christine DeLong ADLM Director, Editorial and Media Relations (p) 202.835.8722 [email protected] Bill Malone ADLM Senior Director, Strategic Communications (p) 202.835.8756 [email protected] SOURCE Association for Diagnostics & Laboratory Medicine (ADLM) WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultClinical Study

28 Jul 2025

·www.globenewswire.com

Emergent Applauds Availability of Over-the-Counter Naloxone in U.S. House of Representatives

GAITHERSBURG, Md., July 28, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announces its recognition of the U.S. House of Representatives for adding over-the-counter (OTC) naloxone to every AED location in its buildings, providing direct access to first responders and anyone coming across an individual who may be experiencing an opioid overdose. This effort has been led by Representative Buddy Carter (R-GA), with his team and congressional constituents, who have kept this public health issue a priority. Expanding access to potentially life-saving treatments is critical to saving more Americans and their families from an opioid overdose death. Emergent remains focused on saving lives through efforts to increase access, awareness and the availability of NARCAN® Nasal Spray 4 mg and KLOXXADO® Nasal Spray 8 mg. Emergent strives to engage with key stakeholders committed to reducing overdose deaths, as one death is one too many. “The efforts of Representative Carter (R-GA) to make naloxone readily available in the U.S. House of Representatives are commendable, and we are pleased to recognize his work to help save a life during an opioid overdose emergency,” said Joe Papa, president and chief executive officer at Emergent. “We believe the over-the-counter availability of naloxone, including our product, NARCAN® Nasal Spray, has directly contributed to the reduction in overdose deaths reported by the U.S. Centers for Disease Control and Prevention. Measures like this reinforce the importance of having life-saving naloxone nearby as an opioid overdose can happen to anyone, anywhere and at any time.” In 2023, Emergent launched NARCAN® Nasal Spray as the first OTC opioid overdose reversal treatment. With more than 85 million doses distributed in the U.S. and Canada since 2016, it is an important tool in helping save lives from opioid overdose, including those caused by fentanyl. Emergent is the leading U.S. supplier of nasal naloxone, and offers an expanded range of products to support public interest groups, workplaces/businesses, as well as patients, consumers and healthcare providers. NARCAN® (naloxone HCl) Nasal Spray 4 mg (two-dose carton)NARCAN® Nasal Spray Wall Unit Kit: includes wall unit cabinet with alarm, poster and wayfinder signKLOXXADO® (naloxone HCl) Nasal Spray 8 mg (two-dose carton)Convenience Kits: includes medical grade components including: One hard case with internal pockets, one medical grade CPR mask, one pair of nitrile examination gloves Visit NARCANDirect® or one of Emergent’s product sites, KLOXXADO.com and NARCAN.com to learn how to be prepared in an opioid overdose emergency with life-saving intranasal naloxone. About NARCAN® Nasal SprayNARCAN® Naloxone HCl Nasal Spray 4 mg is the first FDA-approved, over-the-counter (OTC) 4 mg naloxone product for the emergency treatment of opioid overdose. NARCAN® Nasal Spray is not a substitute for emergency medical care. Repeat dosing may be necessary. Use as directed. Important Safety Information for KLOXXADO® (naloxone HCl) Nasal Spray 8 mg What is KLOXXADO® Nasal Spray? KLOXXADO® Nasal Spray is a prescription medicine used for the treatment of an opioid emergency such as an overdose or a possible opioid overdose in adults and children with signs of breathing problems and severe sleepiness or not being able to respond.KLOXXADO® Nasal Spray is to be given right away and does not take the place of emergency medical care.Get emergency medical help right away after giving the first dose of KLOXXADO® Nasal Spray, even if the person wakes up. What is the most important information I should know about KLOXXADO® Nasal Spray?Get emergency medical help right away after giving the first dose of KLOXXADO® Nasal Spray. The signs and symptoms of an opioid emergency can return after KLOXXADO® Nasal Spray is given. If this happens, give another dose after 2 to 3 minutes using a new KLOXXADO® Nasal Spray and watch the person closely until emergency help is received. The medicine in KLOXXADO® Nasal Spray is safe to use in people who are not taking opioids. KLOXXADO® Nasal Spray is not intended for self-administration. What should I tell my healthcare provider (pharmacist or prescriber) before using KLOXXADO® Nasal Spray?Before using KLOXXADO® Nasal Spray, tell your healthcare provider about all of your medical conditions, including if you: have heart problemsare pregnant or plan to become pregnant. Use of KLOXXADO® Nasal Spray may cause withdrawal symptoms in your unborn baby. Your unborn baby should be examined by a healthcare provider right away after you use KLOXXADO® Nasal Spray.are breastfeeding or plan to breastfeed. It is not known if KLOXXADO® Nasal Spray passes into your breast milk. What are the possible serious side effects of KLOXXADO® Nasal Spray?KLOXXADO® Nasal Spray may cause sudden opioid withdrawal symptoms including body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramping, weakness, and increased blood pressure. In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include seizures, crying more than usual, and increased reflexes. Who should not use KLOXXADO® Nasal Spray?Do not use KLOXXADO® Nasal Spray if you are allergic to naloxone hydrochloride orany of the ingredients in KLOXXADO® Nasal Spray. What are the most common side effects of KLOXXADO® nasal spray?The most common side effects of KLOXXADO® Nasal Spray in adults include stomach-area (abdomen) pain, weakness, dizziness, headache, nose (nasal) discomfort, and a feeling like you are going to faint. These are not all of the possible side effects of KLOXXADO® Nasal Spray. Please see full Prescribing Information, including Patient Information, which includes a more complete discussion of the risks associated with KLOXXADO® Nasal Spray. Always contact your healthcare provider (pharmacist or prescriber) if you have questions or experience any side effects. You are encouraged to report negative side effects to the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. You can also contact Hikma Specialty USA Inc. at: us.hikma@primevigilance.com or call 1-877-845-0689 or 1-800-962-8364. Trademarks and logos are the property of their respective owners. About Emergent BioSolutionsAt Emergent, our mission is to protect and save lives. For over 25 years, we’ve been at work preparing those entrusted with protecting public health. We deliver protective and life-saving solutions for health threats like smallpox, mpox, botulism, Ebola, anthrax and opioid overdose emergencies. To learn more about how we help prepare communities around the world for today’s health challenges and tomorrow’s threats, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify. Investor Contact:Richard S. LindahlExecutive Vice President, CFOlindahlr@ebsi.com Media Contact:Assal HellmerVice President, Communicationsmediarelations@ebsi.com

Drug Approval

100 Deals associated with Naloxone hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01340	Naloxone hydrochloride	A06AH04 V03AB15	DB01183

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Lymphoblastic Leukemia	Canada	Hikma Pharmaceuticals LLC	01 Feb 2025
Opiate Overdose	United States	Emergent Devices, Inc.	13 Apr 1971

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Opioid abuse	Preclinical	United States	Consegna Pharma, Inc.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03751111 (CTgov)	Phase 1/2	Pruritus \| Pruritus Ani	126	Naloxone (Naloxone)	suiqzksxms(irijitawdc) = nqtqnqzvsv gyhachrtuu (kdsnpwpkml, 2.15) View more	-	20 Apr 2025
				Placebo (Placebo)	suiqzksxms(irijitawdc) = uwyarxgalq gyhachrtuu (kdsnpwpkml, 1.99) View more
NCT04473950 (CTgov)	Phase 1	Opioid-Related Disorders \| Chronic Pain	10	Placebo+Naloxone Hydrochloride (Pain Group)	gtsswirrxb(jnqlwonixs) = ilwfwjbidc ilbsnzdgsm (hqlkkzkcad, 1.17) View more	-	26 Mar 2025
				Placebo+Naloxone Hydrochloride (No Pain Group)	gtsswirrxb(jnqlwonixs) = kwmvrfmaxe ilbsnzdgsm (hqlkkzkcad, 0.92) View more
NCT03176316 (FusionIleus, CTgov)	Phase 4	Ileus	53	Naloxone	rjijpzzedl = bavaxhdkul tziuzngwnc (iwkewchuoq, pxivydbhbn - dfjmzruoyx) View more	-	01 Jul 2024
NCT03149770 (CTgov)	Phase 2	Diabetes Mellitus, Type 1 \| Hypoglycemia	30	Naloxone (Naloxone)	tbqfrxxcmz(kshuttogne) = pmxukhiadx wgjrnppdtm (ascqnsnwtg, 12) View more	-	16 Apr 2024
				placebo (Placebo)	tbqfrxxcmz(kshuttogne) = wvsygxhtyt wgjrnppdtm (ascqnsnwtg, 13) View more
NCT04764630 (Pubmed \| JAMA Netw Open)	Phase 1	Opiate Overdose	21	1 dose at 0, 2.5, 5, and 7.5 minutes	ufvrehdfhb(fqsmjwyynb) = qxvocevmpm bnvzbyaqrv (dsecgodege )	-	23 Jan 2024
				2 doses at 0 and 2.5 minutes	ufvrehdfhb(fqsmjwyynb) = oosyjqswzt bnvzbyaqrv (dsecgodege )
NCT03570099 (Pubmed \| BMJ Open)	Not Applicable	Opiate Overdose	-	Take-home naloxone distribution	qdhzrdivmt(oqsyiuguxw) = hliytkrbrj ftsgxkeonx (vsykabtyam )	-	01 Jan 2024
				intranasal naloxone (Control period (2013-2017))	qdhzrdivmt(oqsyiuguxw) = csvhbteqaa ftsgxkeonx (vsykabtyam )
NCT02700048 (CTgov)	Phase 1/2	Diabetes Mellitus, Type 1 \| Hypoglycemia \| Unconsciousness	11	Intra-nasal saline (Placebo)	yznipxfvym(edwgrolovi) = pywkwhhloy joelctaeuv (ckhsnhantx, ajjasduiyp - cbggwsycjb) View more	-	27 Mar 2023
				intra-nasal naloxone (Treatment With Intra-nasal Naloxone)	yznipxfvym(edwgrolovi) = cygroijcmf joelctaeuv (ckhsnhantx, jvxdpxyach - xljhveipdv) View more
NCT04713709 (Corporate Publications) Manual	Phase 1	Opiate Overdose	56	FMXIN001	tdhuglmkky(smztkrddnc) = rwmstthsoz kyojfcsnld (lveersytps ) View more	Similar	28 Jul 2022
				NARCAN	tdhuglmkky(smztkrddnc) = rbllunfpwj kyojfcsnld (lveersytps ) View more
NCT04764630 (CTgov)	Phase 1	-	21	naloxone (A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min))	xaxtdksozt(koibsetjmo) = tccyasvgan nrecxiwtyx (txyyplpado, 70) View more	-	15 Jul 2022
				naloxone (C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min))	xaxtdksozt(koibsetjmo) = owthysefzw nrecxiwtyx (txyyplpado, 159) View more
NCT02805972 (BEE, CTgov)	Phase 2	Obesity	41	Placebo+Naloxone (Placebo, Then Naloxone)	rnvqgglczj(bhdfsdshph) = cregbqhsxy jpyzdctkho (qpgbciboor, atxkintzyu - klidpadbym) View more	-	03 Nov 2021
				Placebo+Naloxone (Naloxone, Then Placebo)	rnvqgglczj(bhdfsdshph) = pigwzlxuwh jpyzdctkho (qpgbciboor, dbwrhzahnw - hfqhjegqxa) View more

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