Adapt Pharma, a privately held pharmaceutical company committed to positively impacting the lives of patients with specialist medical conditions, has 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. 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 US 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 US 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.
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.