Opiant Pharmaceuticals has landed fast-track designation for its nasal nalmefene formulation, teeing it up to benefit from close communication with the FDA as it prepares to seek approval for the opioid overdose drug in the coming months.
The candidate, OPNT003, is a nasal formulation of nalmefene that is designed to improve outcomes in people who overdose on synthetic opioids. An injectable formulation of nalmefene won approval in the 1990s but was pulled after a little more than a decade on the market. Since then, synthetic opioids such as Fentanyl have created new challenges, leading Opiant to identify the half-life and affinity for opiate receptors of nalmefene as a good fit for the current unmet needs.
Opiant is now nearing the point at which it will find out whether its confidence in nalmefene translates into commercial success. Having posted pharmacokinetic data over the summer, Opiant is working to wrap up a pharmacodynamic study and seek FDA approval via the 505(b)(2) regulatory pathway in the coming months.
The FDA has delivered a boost to Opiant’s plans by adding OPNT003 to its fast track. The status gives Opiant the chance to have earlier, more frequent communication with the FDA and potentially to file a rolling submission with the agency.
“The designation of Fast Track status by the FDA underscores the potential for OPNT003 to represent a major advance in opioid overdose treatment that can help communities better respond to this escalating crisis. Opiant is focused on advancing the OPNT003 development program as rapidly as possible and the granting of Fast Track designation represents significant additional support toward this objective,” Opiant CEO Roger Crystal said in a statement.
Opiant developed the Narcan nasal spray now sold by Emergent Biosolutions and receives royalties on sales of the medicine. If Opiant is right, OPNT003 will offer advantages over the incumbent drug in some situations.