- Thinly traded nano cap Opiant Pharmaceuticals (OPNT +2.2%) perks up, albeit on light volume, on the heels of its regulatory plan for OPNT003, a long-acting intranasal treatment for opioid overdose.
- Based on FDA feedback, the company will pursue a 505(b)(2) development path which allows the inclusion of data generated by others. The company anticipates filing a New Drug Application in 2020.
- The active ingredient in OPNT003 is nalmefene, combined with an absorption enhancer called Intravail, developed by Aegis Therapeutics. Phase 1 data showed a rapid increase in plasma levels with an onset of action faster than an intramuscular injection. It also has a half-life of 6.7 - 7.8 hours, over three times as long as NARCAN (naloxone) (two hours), the only current FDA-approved nasal spray for the emergency treatment of opioid overdose.
- Now read: Your Daily Pharma Scoop: A Look At Advaxis, AstraZeneca's Positive Results, AbbVie Reports Q4 Results
Original article