FDA approves 2mg Narcan nasal spray for opioid overdose treatment

Adapt Pharma said today that 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 approval comes 1 year after the FDA approved its 4mg formulation, which was the 1st needle-free version of naloxone.

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.

Adapt Pharma’s Narcan 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.

In November, Camarus AB (STO:CAMX) and Braeburn Pharmaceuticals said that a late-stage trial of its injectable opioid dependence treatment was successful. CMAX shares surged 16% at the beginning of the week following the announcement.

The injectable buprenorphine therapy could be another treatment used to combat the growing opioid epidemic in the United States, which claimed the lives of more than 47,000 Americans in 2014, according to the Wall Street Journal. In that same year, 650,000 Americans received buprenorphine to treat opioid addiction.

Braeburn, which is developing a match-size implant to fight opioid addiction, said this month that it plans to raise $150 million by offering 7,692,308 shares of its common stock. The Princeton, N.J.-based company wrote in regulatory filings that it expects the initial public offering price for its stock to be between $18.00 and $21.00 apiece.

Apple Tree Partners has indicated an interest in buying $50 million of shares of Braeburn’s common stock and has also agreed to purchase $40 million of the company’s common stock in a private placement upon the completion of the public offering.