naloxone nasal spray / Generic mfg. - LARVOL DELTA

Impact of Medicaid expansion on naloxone dispensing: A narrative review. (PubMed, J Opioid Manag) - "Few studies have explored the association between Medicaid expansion and improved access to naloxone. Three of four studies found that expansion was associated with increased naloxone prescriptions and pharmacy availability. Future studies should incorporate standardized measures to assess the impact of Medicaid expansion on naloxone dispensing across a greater number of states and utilize longitudinal data to evaluate its impact over time."

Journal • Reimbursement • Review • US reimbursement

In brief: Rextovy - another OTC naloxone nasal spray. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Substance Abuse

Development of an In Vitro Permeation Test Framework For Naloxone Hydrochloride Intranasal Spray: Establishing IVIVR for Bioequivalence Assessment. (PubMed, Pharm Res) - "These findings indicate that a tissue-based IVPT-IVIVR framework may provide a translational tool for relating in vitro permeation behavior to systemic exposure, supporting its utility in formulation development and BE risk assessment of rapidly acting IN naloxone products."

Journal • Preclinical • Addiction (Opioid and Alcohol) • CNS Disorders

ROAR: Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists (clinicaltrials.gov) - P1 | N=58 | Terminated | Sponsor: Leiden University Medical Center | N=24 ➔ 58 | Trial completion date: Oct 2026 ➔ Mar 2026 | Recruiting ➔ Terminated | Trial primary completion date: Aug 2026 ➔ Mar 2026; Recruitment of chronic opioid users was substantially lower than anticipated despite extensive recruitment efforts; the study was therefore closed before reaching the planned sample size.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Depression • Mood Disorders • Psychiatry

NBIM: Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl (clinicaltrials.gov) - P3 | N=3 | Active, not recruiting | Sponsor: University of Maryland, Baltimore | Recruiting ➔ Active, not recruiting | N=25 ➔ 3 | Trial completion date: Jan 2026 ➔ Jan 2030 | Trial primary completion date: Jan 2026 ➔ Jan 2030

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Substance Abuse

Availability of Naloxone in Retail Pharmacies Following Introduction of Over-the-Counter Status. (PubMed, JAMA Netw Open) - "In March 2023, the US Food and Drug Administration approved the first over-the-counter (OTC) naloxone nasal spray, representing a substantial shift in public health policy and pharmacy practice...Although enactment of the OTC policy was necessary, its intended benefits were not realized equally in practice. Expanding pharmacist education and targeting support for independent and medical-affiliated pharmacies may help improve naloxone access, especially in rural and underserved areas."

Journal

FDA Approves Additional Naloxone Nasal Spray for Opioid Overdose. (PubMed, JAMA) - No abstract available

FDA event • Journal • Addiction (Opioid and Alcohol) • CNS Disorders

Availability and Cost of Naloxone Over Time: A Longitudinal Secret Shopper Study in North Carolina Community Pharmacies. (PubMed, J Am Pharm Assoc (2003)) - "Naloxone availability and cost improved over time. Independent pharmacies continued to have lower availability and higher costs than chain pharmacies. Generic naloxone was more expensive on average than brand-name naloxone, and few pharmacies stocked both products."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders

Public perceptions and willingness-to-pay regarding over-the-counter (OTC) naloxone: A national cross-sectional survey informed by the Theory of Planned Behavior. (PubMed, Explor Res Clin Soc Pharm) - "Therefore, the purpose of this study was to better understand the U.S. public's knowledge, perceptions, and willingness-to-pay regarding OTC naloxone nasal spray, and differences across sociodemographic characteristics...Perceptions, intentions, and WTP differed across sociodemographics. Future studies may further investigate these disparities."

Journal • Pain

Pharmacy-level barriers to opioid overdose prevention: availability and accessibility of naloxone and buprenorphine-naloxone in high-risk Texas counties. (PubMed, Harm Reduct J) - "Significant gaps remain in the availability and accessibility of NNS and BUP/NX in southeast Texas community pharmacies. Persistent barriers including supply chain limitations, internal policies, and stigma continue to impede timely access to these lifesaving medications. Reducing opioid overdose deaths requires coordinated efforts among pharmacies, suppliers, and regulators to ensure equitable MOUD access in Texas."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Substance Abuse

Reversal of opioid-induced respiratory depression with opioid antagonists - a pharmacokinetic pharmacodynamic modeling study in opioid nave individuals and chronic opioid users under real-life conditions (clinicaltrialsregister.eu) - P4 | N=24 | Completed | Sponsor: Leids Universitair Medisch Centrum (LUMC) | Recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Mood Disorders • Psychiatry • Substance Abuse

Increasing Buprenorphine and Naloxone Access in Texas Community Pharmacies Through an Academic Detailing Intervention. (PubMed, Subst Use Addctn J) - "A mailed academic detailing intervention did not change NNS availability or BUP/NX stocking but did modestly increase willingness to order BUP/NX. This intervention is easily replicable and scalable, but modifications to increase the magnitude of its effect are needed."

Journal • Substance Abuse

Emergent BioSolutions Receives U.S. FDA Approval on Supplemental New Drug Application for NARCAN Nasal Spray to be Packaged in a New Carrying Case, Making Life-Saving Naloxone More Accessible for Everyday Preparedness (The Manila Times)

FDA approval • Addiction (Opioid and Alcohol)

Debating the Future of Opioid Overdose Reversal: Nalmefene or Naloxone? (ASHP 2025) - "Justify appropriate clinical scenarios for nalmefene and naloxone considering risks for withdrawal and overdose in the synthetic opioid era. Learning Objectives: Compare the pharmacokinetic profiles of nalmefene and naloxone nasal sprays.Evaluate real-world clinical data of nalmefene and naloxone nasal sprays.Justify appropriate clinical scenarios for nalmefene and naloxone considering risks for withdrawal and overdose in the synthetic opioid era."

Addiction (Opioid and Alcohol) • CNS Disorders

Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF) (clinicaltrials.gov) - P4 | N=4 | Terminated | Sponsor: Albert Einstein College of Medicine | Study was sufficiently powered to conduct analysis for 2 of the arms. Remaining Aims were never initiated.

Enrollment change • Trial termination • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

Neffy and Narcan nasal sprays: potential for look-alike, sound-alike medication errors. (PubMed, Am J Nurs) - No abstract available

Journal

Estimates of first-year OTC naloxone sales in four U.S. states with high rates of opioid overdose deaths: KY, MA, NY, OH. (PubMed, J Subst Use Addict Treat) - "OTC naloxone increases access, though the price may deter people with low income, as evidenced by our findings of lower sales among areas with high social deprivation, emphasizing the importance of naloxone access laws, opioid education and naloxone distribution programs, and Medicaid coverage. OTC naloxone creates a new channel for market penetration, satisfying a previously untapped demand, and supports naloxone saturation."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders

Teaching the administration of naloxone via nasal spray in virtual reality: a pilot study. (PubMed, Resusc Plus) - No abstract available

Journal

Provincial survey regarding naloxone dispense in community pharmacies (PAS 2025) - "The survey included 121 community pharmacies. Almost all pharmacies (99%) offer take-home naloxone kits, with 58% dispensing pre-packaged kits, 52% of which containing naloxone nasal sprays. Experience with pediatric naloxone dispensation was generally poor as most pharmacies (88%) have only served take-home naloxone kits to adult patients."

Addiction (Opioid and Alcohol) • CNS Disorders • Pediatrics

Padagis Extends the Shelf-Life of Naloxone HCl Nasal Spray 4 mg to 36 Months (PRNewswire) - "Padagis...announced today its over-the-counter (OTC) Naloxone HCl Nasal Spray 4 mg has now obtained an extended shelf-life of 36 months. Padagis' Naloxone HCl Nasal Spray is an original prescription-strength medication designed to rapidly reverse the effects of a life-threatening opioid overdose...'At just $29.99 for a two-dose pack, Padagis 4 mg naloxone nasal spray remains the most affordable OTC option available to consumers on Amazon, and now, with a longer shelf life, we're delivering even greater value to those who need it most.'....The three-year expiration will apply to newly manufactured medicine that is planned to be released by Padagis as early as late second quarter of this year. Padagis encourages all customers and consumers to follow the expiration date printed on the product packaging."

Commercial • Addiction (Opioid and Alcohol)

Naloxone nasal spray kits now available at Guelph Public Library (CTV News) - "The Guelph Public Library now offers a treatment that has the potential to save lives...Nasal spray Naloxone kits are now available at the main branch on Norfolk Street. Anyone looking for a kit can pick one up at the basement level Info B Desk....Naloxone is a fast-acting medication that can temporarily reverse the effects of an opioid overdose, allowing others enough time to seek medical attention...Staff at the library can provide a kit to anyone who asks for one and training is also available."

Commercial • Addiction (Opioid and Alcohol)

Over the counter naloxone nasal spray: A new hope for opioid crisis management in Pakistan. (PubMed, J Pak Med Assoc) - No abstract available

Journal

Polyrizon Initiates Preclinical Studies for Intranasal Naloxone Targeting Opioid Overdose Based on Its Innovative T&T Platform (GlobeNewswire) - "Polyrizon Ltd...announced today the initiation of preclinical studies for intranasal Naloxone, a life-saving opioid overdose treatment...These studies will assess key parameters, such as drug loading capacity, release kinetics, nasal deposition and stability, laying the groundwork for further safety and efficacy testing in preclinical and clinical studies."

Preclinical • Addiction (Opioid and Alcohol) • CNS Disorders

Expanded access to intranasal naloxone and training among police officers in Western Australia: A pilot evaluation study. (PubMed, Drug Alcohol Rev) - "The findings demonstrate the acceptability and training effectiveness of a police force naloxone administration program in Australia. The pilot emphasises the life-saving potential of equipping police officers with naloxone and serves as an example for police departments in other Australian jurisdictions to roll out similar programs customised to the Australian context and beyond."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders

Over-the-counter naloxone availability: Insights from rural community pharmacists in the Southern US. (PubMed, J Am Pharm Assoc (2003)) - "Despite OTC Narcan® nasal spray being available in pharmacies as of September 2023, availability of this life-saving medication remains less than ideal in rural and Southern pharmacies. These findings emphasize the need for further educational and policy interventions to improve naloxone availability."

Journal