naloxone nasal spray / Generic mfg. - LARVOL DELTA

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

ROAR: Reversal of Opioid-induced Respiratory Depression with Opioid Antagonists (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Leiden University Medical Center | Trial primary completion date: Aug 2024 ➔ Aug 2026 | Completed ➔ Recruiting | Trial completion date: Oct 2024 ➔ Oct 2026

Enrollment open • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

Insurance coverage and consistent pricing is needed for over-the-counter naloxone. (PubMed, J Opioid Manag) - "Failure to cover naloxone can reduce access and increase risk of overdose death. We suggest federal policy implementation that requires universal insurance coverage of at least one formulation of naloxone and to utilize national opioid settlement funds to pay for naloxone nasal spray to ensure equitable access to this lifesaving medication."

Journal • Pricing • Reimbursement • US reimbursement • Addiction (Opioid and Alcohol)

ROAR: Reversal of Opioid-induced Respiratory Depression with Opioid Antagonists (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Leiden University Medical Center | Recruiting ➔ Completed | Trial completion date: May 2024 ➔ Oct 2024 | Trial primary completion date: May 2024 ➔ Aug 2024

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

Naloxone Distribution Program (AAP-NCE 2024) - "If the patient and/or LAR assents to receive a naloxone take-home kit, they will be provided with a 2-pack 4 mg naloxone intranasal spray kit, instructions on administration of the medication, and outpatient resources through a social work consult.Outcome Measures: - Percentage of patients triggering Opioid Risk alert in EHR who were offered naloxone (Naloxone THKs offered/number of eligible patients) - see Run Chart 1... In a six-month pre-intervention period, an earlier version of our alert criteria yielded 36 patients that would have triggered the alert. Additionally, ICD codes denoting opioid use disorders (n= 6) and patients who had an order for naloxone administered in the ED during the same period (n=5) were identified. During that time, 26 prescriptions were provided for naloxone, suggesting only 55% of possibly eligible patients were offered naloxone (26/47)."

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

Perceptions Towards Naloxone among Patients with Cancer Receiving Opioids. (PubMed, J Pain Symptom Manage) - "Most patients understood the benefits of naloxone and felt safe having one at home. More research is needed to identify knowledge gaps and develop educational strategies for those who find it non-beneficial."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Oncology • Pain

Naloxone Availability and Cost After Transition to an Over-the-Counter Product. (PubMed, JAMA Health Forum) - "The Food and Drug Administration's approval of OTC naloxone nasal spray contributed to an increase in pharmacy-based availability of naloxone and a reduction of its cost for cash-paying patients. Cost was higher at independent pharmacies compared with chain pharmacies and lower in urban pharmacies compared with suburban and rural pharmacies."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders

Accessibility of Naloxone in Pharmacies Registered Under the Illinois Standing Order. (PubMed, West J Emerg Med) - "Naloxone nasal spray (86.4%) was the formulation most commonly stocked...Among pharmacies in Illinois that formally registered to dispense naloxone without a prescription, the availability of naloxone remains limited. Additional interventions may be needed to maximize the potential impact of a statewide standing order."

Journal

Association Between Cost Sharing and Naloxone Prescription Dispensing. (PubMed, JAMA) - "The analysis included claims for naloxone nasal spray among commercially insured patients and Medicare patients that occurred during the 60 days before January 1, 2021, through 59 days after January 1, 2021...The results from the fuzzy regression discontinuity analysis suggest a decision by commercial and Medicare plans to increase naloxone cost sharing by $10 would be associated with percentage-point increases of 3.1 (95% CI, 2.2-4.1) and 2.3 (95% CI, 1.4-3.2), respectively, in the probability of abandonment. The elimination of cost sharing might be associated with increased naloxone dispensing to commercially insured and Medicare patients."

Journal • Addiction (Opioid and Alcohol)

Whole body physiology model to simulate respiratory depression of fentanyl and associated naloxone reversal. (PubMed, Commun Med (Lond)) - "This paper investigates the total naloxone dose needed to properly reverse respiratory depression associated with fentanyl overdose. We show that the current guidelines for a rescue dose may be much lower than required."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Mood Disorders • Psychiatry

Evaluation of Strategies to Enhance Community-Based Naloxone Distribution Supported by an Opioid Settlement. (PubMed, JAMA Netw Open) - "This decision analytical modeling study used PROFOUND (Prevention and Rescue of Fentanyl and Other Opioid Overdoses Using Optimized Naloxone Distribution Strategies), a previously published simulation model, to forecast annual OODs between January 2023 and December 2025...The study modeled expanded naloxone distribution supported by the state's opioid settlement (50 000 naloxone nasal spray kits each year)...Notably, synergistic associations were observed when combining both interventions: increased naloxone distribution with the 2 approaches and a 60% increase in witnessed overdoses could reduce OODs in 2025 by 33.5% (95% SI, 17.1%-50.4%) and 37.4% (95% SI, 19.6%-56.3%), respectively. These findings suggest that interventions to address solitary drug use are needed to maximize the impact of continued efforts to increase community-based naloxone distribution, which may be particularly important for jurisdictions that have strong community-based naloxone distribution..."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders

No-lax-zone: Side Effects That Can Steal Your Breath Away (ATS 2024) - "Introduction: In March 2023, the FDA approved the first over-the-counter naloxone nasal spray, a critical tool in combating opioid overdose fatalities...Case Presentation: A 24-year-old male with a fentanyl use disorder was found unresponsive in his car and received 4mg intranasal naloxone from EMS...The patient was extubated within 24 hours and discharged four days later on room air, commencing suboxone therapy... In this unique case of naloxone-induced pulmonary edema in a young patient administered 4mg intranasal naloxone, the rapid onset of symptoms and subsequent clinical improvement strongly suggest this rare complication. Although left ventricular dysfunction likely played a role, it underscores the importance of recognizing and managing this adverse effect, particularly with the increasing availability of intranasal naloxone. Raising awareness among patients and healthcare providers about the potential complications associated with naloxone is vital to ensure..."

Adverse events • Addiction (Opioid and Alcohol) • Cardiomyopathy • Cardiovascular • CNS Disorders • Heart Failure • Respiratory Diseases

Naloxone Prescribing for Opioid Overdose: Education Alone is Not Enough (APA 2024) - "The Center for Disease Control (CDC) has promoted a set of evidence-based strategies to prevent opioid overdose, including targeted naloxone intranasal spray distribution...Multiple factors outside education contribute to discharge management such as time constraint and changes in primary providers. We have requested that our electronic medical record information technology team to add an automated prompt, such as the one currently implemented for smoking cessation, to lead to a greater proportion of at-risk patients receiving prescriptions for naloxone."

Addiction (Opioid and Alcohol) • CNS Disorders • Tobacco Cessation

Toward Standardized Prevention of Opioid-Related Deaths in Free-Standing Emergency Departments and Beyond (APA 2024) - "She re- presented with an overdose within 5 hours was again given naloxone and discharged and was shortly found deceased due to a fentanyl overdose confirmed by post-mortem county coroner examination...The CDC has recognized a set of evidence-based strategies for preventing opioid overdose which includes targeted naloxone intranasal spray distribution...These laws and their implications will be reviewed. Learning Objectives Objective One: Highlight the lack of standardization of hospital-based interventions for prevention of death in patients with recurrent presentations of opioid overdose by reviewing a case study Objective Two: Educate clinicians on the use of involuntary civil commitment laws for substance use Objective Three: Illustrate how peer support and immediate access to medication assisted treatment can save lives Objective Four: Objective Five:"

Addiction (Opioid and Alcohol) • CNS Disorders • Grave’s Disease • Psychiatry • Schizophrenia • Substance Abuse

Fact vs. fiction: naloxone in the treatment of opioid-induced respiratory depression in the current era of synthetic opioids. (PubMed, Front Public Health) - "Approximately 90% of fatal opioid-related deaths are due to synthetic opioids such as fentanyl, most of which is illicitly manufactured and distributed either on its own or as an adulterant to other drugs of abuse such as cocaine or methamphetamine...Naloxone is the main treatment used to reverse OIRD and is available as nasal sprays, prefilled naloxone injection devices, and generic naloxone for injection. An overdose needs to be treated as soon as possible to avoid death, and synthetic opioids such as fentanyl are up to 50 times more potent than heroin, so the availability of new, higher-dose, 5-mg prefilled injection or 8-mg intranasal spray naloxone preparations are important additions for emergency treatment of OIRDs, especially by lay people in the community...Education about the benefits of naloxone remains important not only in informing people about how to treat emergency OIRDs but also how to obtain naloxone. A call to emergency services is also essential after..."

Journal • Review • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Mood Disorders • Psychiatry • Respiratory Diseases