Kloxxado (naloxone intranasal spray) / Hikma - LARVOL DELTA

Hikma announces Health Canada approval of KLOXXADO (naloxone HCl) Nasal Spray 8 mg (GlobeNewswire) - "ikma Pharmaceuticals PLC...announces the approval of KLOXXADO (naloxone HCl) Nasal Spray 8 mg, by Health Canada for the treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult patients...Following the approval of KLOXXADO Nasal Spray, Emergent will engage Canadian agencies, private payers and provincial formularies, and aims to make KLOXXADO available via prescription as early as 2026."

Canada approval • Launch Canada • Addiction (Opioid and Alcohol) • CNS Disorders

Emergent BioSolutions Gains Exclusive Commercial Rights to KLOXXADO (naloxone HCI) Nasal Spray from Hikma Pharmaceuticals (GlobeNewswire) - "Emergent BioSolutions Inc...announced today that it has entered into an agreement to obtain exclusive commercial rights in the U.S. and Canada to Hikma Pharmaceuticals’ KLOXXADO (naloxone HCl) Nasal Spray, an 8 mg naloxone agent that is approved for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. This six-year agreement complements and strengthens Emergent’s mission to protect, enhance, and save lives by helping to reduce opioid overdose deaths —providing compelling product options, combined with a commitment to increasing naloxone access, awareness, and education....Under the terms of the agreement, Hikma will continue to manufacture KLOXXADO Nasal Spray 8 mg to maintain distribution and availability."

Licensing / partnership • Addiction (Opioid and Alcohol)

Comparison of Kloxxado® and Narcan® Usage Following Updates to Computerized Patient Record System (AAPP 2024) - No abstract available

Clinical

Nalmefene nasal spray (Opvee) for reversal of opioid overdose. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Drugs for opioid use disorder. (PubMed, Med Lett Drugs Ther) - No abstract available

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

In brief: Over-the-counter Narcan nasal spray. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol)

Nalmefene returns for reversal of opioid overdose. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol) • CNS Disorders

Real-world study of multiple naloxone administration for opioid overdose reversal among bystanders. (PubMed, Harm Reduct J) - "MNA occurred in most overdose events, often involving more sprays than are provided in one Narcan® nasal spray box, and participants predominantly expressed having a stronger preference for and confidence in an 8 mg compared to a 4 mg nasal spray. This suggests the need and desire for a higher dose naloxone nasal spray formulation option. Given that bystanders may be the first to administer naloxone to someone experiencing an opioid overdose, ensuring access to an adequate naloxone supply is critical in addressing the opioid overdose epidemic."

Journal • Real-world evidence • Addiction (Opioid and Alcohol) • CNS Disorders • Infectious Disease • Novel Coronavirus Disease

Zimhi - a higher-dose injectable naloxone for opioid overdose. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol) • CNS Disorders

Naloxone: What You Need to Know (ASAM 2022) - "Naloxone administration appears to be associated with a high rate of adverse effects, particularly precipitated opioid withdrawal, likely due to the greater physiological dependence caused by fentanyl...There will be availability of the panelists to answer audience questions. Learning Objectives: Learners will be able to: - Understand the pharmacology of naloxone and clinical application in the management of opioid overdose - Review the existing evidence for management of precipitated opioid withdrawal in patients after using full-opioid antagonists - Describe the use of buprenorphine following overdose reversal by naloxone to increase patient engagement in treatment"

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

Higher-Dose Naloxone Nasal Spray (Kloxxado) for Opioid Overdose. (PubMed, JAMA) - No abstract available

Journal • Addiction (Opioid and Alcohol) • CNS Disorders

In brief: Higher-dose naloxone nasal spray (Kloxxado) for opioid overdose. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol) • CNS Disorders

Hikma acquisition expands nasal spray capabilities and pipeline (Hikma Press Release) - "Hikma Pharmaceuticals PLC...today announces that it has signed an asset purchase agreement with Insys Therapeutics Inc. (Insys) to acquire a complementary manufacturing platform and two pipeline products....Hikma has agreed to acquire unit-dose nasal and sublingual spray manufacturing equipment, as well as two pipeline products, naloxone 505(b)2 nasal spray..."

M&A

FDA Accepts New Drug Application for INSYS Therapeutics’ Naloxone Nasal Spray for the Emergency Treatment of Known or Suspected Opioid Overdose (GlobeNewswire, Insys Therapeutics, Inc.) - "INSYS Therapeutics, Inc....announced today that its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational, proprietary naloxone nasal spray for the emergency treatment of known or suspected opioid overdose in both adult and pediatric patients has been accepted for filing. INSYS’ naloxone nasal spray is a single unit dose spray device that delivers 8mg naloxone dose."

Clinical • NDA • Regulatory

INSYS Therapeutics to Present Poster of Pharmacokinetic Study of Naloxone Novel Nasal Spray at The College on Problems of Drug Dependence Annual Scientific Meeting (GlobeNewswire, Insys Therapeutics, Inc.) - INSYS Therapeutics, Inc....today announced the Company will present a poster of its pharmacokinetic (PK) study of its novel naloxone nasal spray versus intravenous and intramuscular injection at the College on Problems of Drug Dependence (CPDD)’s 81st Annual Scientific Meeting in San Antonio, Texas on Monday, June 17, 2019 at 8:00am Central Time.

PK/PD data

A Study to Compare Bioavailability of Naloxone Nasal Spray and Naloxone Hydrochloride (HCl) Intramuscular Injection (IM) in Healthy Volunteers (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: INSYS Therapeutics Inc

Clinical • New P1 trial

A Study to Compare Bioavailability of Naloxone Nasal Spray, Naloxone Hydrochloride (HCl) Intravenous (IV) and Intramuscular Injection (IM) in Healthy Volunteers (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: INSYS Therapeutics Inc

Clinical • New P1 trial