Adapt Pharma Announces European Marketing Application Filed For Naloxone Hydrochloride Nasal Spray

February 21, 2017

ADAPT PHARMA ANNOUNCES EUROPEAN MARKETING APPLICATION FILED FOR NALOXONE HYDROCHLORIDE NASAL SPRAY

 

Dublin, Ireland, February 21, 2017 Adapt Pharma Limited (Adapt Pharma) today announced that a marketing application for Naloxone Hydrochloride (HCl) Nasal Spray for the treatment of opioid overdose has been filed in Europe.

Naloxone has been used as an injection to treat opioid overdose for more than 40 years [1]. Naloxone HCl Nasal Spray is a ready-to-use, needle-free device that delivers a single dose of naloxone in a 0.1 ml nasal spray. Naloxone HCl Nasal Spray requires no assembly or priming prior to use.

Health Canada and the U.S. Food and Drug Administration approved Narcan® (naloxone) Nasal Spray in 2016 and 2015, respectively. This product is the first and only nasal formulation of naloxone approved in these territories and is already the most frequently prescribed naloxone at U.S. retail pharmacies.

Data published from a 29-patient open-label, randomized, 5-period, 5-treatment, 5-sequence pharmacokinetic study demonstrated that naloxone nasal spray 2 mg and 4 mg rapidly achieved naloxone plasma levels significantly greater than those achieved by 0.4 mg naloxone administered by intramuscular injection. [2]

Opioid overdose is a significant public health issue in Europe, where 6,300 to 8,000 drug overdoses occur annually, the vast majority of which involve opioids. [1]

In response to the growing public health need, Adapt Pharma is supplying Narcan® Nasal Spray through a Managed Access Program, full details can be obtained via email inquiry. (MAP@Durbinglobal.com).

 

ABOUT ADAPT PHARMA LIMITED

Adapt Pharma Limited is a privately held pharmaceutical company committed to positively impacting the lives of patients with specialist medical conditions. Adapt Pharma’s strategy is to identify, evaluate, selectively acquire and enhance the value of late stage development, and FDA approved, pharmaceutical products. Adapt Pharma’s company headquarters are in Dublin, Ireland. For more information please visit: www.adaptpharma.com

 

REFERENCES

  1. European Monitoring Centre for Drugs and Drug Addiction (2016) Insight Report – Preventing opioid overdose deaths with take-home naloxone.
  2. Krieter P, Chiang N, Gyaw S, Skolnick P, Crystal R, Keegan F, et al. Pharmacokinetic Properties and Human Use Characteristics of an FDA Approved Intranasal Naloxone Product for the Treatment of Opioid Overdose. J Clin Pharmacol. 2016.