By Josh Beckerman
Adamis Pharmaceuticals Corp. said the U.S. Food and Drug Administration has accepted for review its New Drug Application for a naloxone injection product used to treat opioid overdoses.
The FDA provided a target agency action date of Oct. 31.
Adamis shares /zigman2/quotes/205166351/composite ADMP +5.41% traded up 6% after hours to $2.99.
Naloxone, widely used to fight overdoses, is sold as Narcan in nasal spray form. Narcan was developed by Opiant Pharmaceuticals Inc. (OPNT) and licensed to Adapt Pharma. Adapt was sold to Emergent BioSolutions Inc. (EBS) in an October deal that included $635 million of cash and stock upfront.
Adamis, which has called its naloxone injection a higher dose product, noted in February that an article in the journal Substance Abuse Treatment, Prevention, and Policy said higher doses could be a “simple countermeasure” amid more abuse of synthetic opioids like fentanyl.
The FDA has called for increased availability of naloxone, including labeling that would help over-the-counter sales.
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