Adapt Pharma said today that it filed a European Marketing Application for its naloxone hydrochloride nasal spray for the treatment of opioid overdose.
The Dublin-based company’s product is a ready-to-use, needle-free device that delivers a single dose of naloxone in an 0.1 mL nasal spray and does not require assembly prior to use, according to Adapt Pharma.
The company’s nasal sprays are comprised of concentrated naloxone that provides emergency treatment for opioid overdose, including prescription opioid painkiller-related overdose, fentayl, carfentanil, and heroin-related overdose.
Healthcare practitioners have used injectable naloxone to treat opioid overdose patients for more than 40 years. In 2016, Health Canada approved Adapt Pharma’s Narcan naloxone nasal spray – 1 year after the FDA approved the product in the U.S.
The company’s products are the 1st and only nasal formulation of naloxone available in the U.S., Canada and Europe, according to Adapt Pharma, and its nasal sprays are the most frequently prescribed formulation of naloxone in U.S.-based pharmacies.
A 29-patient pharmacokinetic study demonstrated that the naloxone nasal spray achieved naloxone plasma levels greater than those achieved by the instramuscular naloxone injection, Adapt Pharma reported.
In January this year, the FDA approved the 2mg formulation of its Narcan nasal spray for the emergency treatment of opioid overdose.
The 2mg dose is intended for opioid-dependent patients that are at risk for severe withdrawal, but are not at a high risk for continued opioid exposure.
The 4mg nasal spray has been commercially available since February last year, after it was reviewed and approved by the FDA under an expedited pathway.
