The Biomedical Advanced Research and Development Authority (BARDA) is providing further funding to Opiant Pharmaceuticals, coughing up $2.1 million to support the preparation and filing of an application for approval of OPNT003.
California-based Opiant has secured a series of awards from BARDA, bringing in $8.7 million to add to a $7.4 million grant from the National Institute on Drug Abuse. The funding has brought Opiant to the cusp of completing a filing for FDA approval of OPNT003, a nasal formulation of nalmefene. The FDA approved an injectable formulation of the drug in 1995, only for Baxter to discontinue the product, Revex, in 2008.
Opiant’s interest in nalmefene is built on evidence that the molecule’s half-life and affinity for opiate receptors make it a good fit for an era in which synthetic opioids such as fentanyl are responsible for some overdoses.
Having shown noninferiority to nasal naloxone in a pharmacodynamic study, Opiant recently began a rolling submission for OPNT003 at the FDA and expanded a collaboration with Aptar Pharma to support the production of the product. Opiant plans to use the 505(b)(2) pathway to bring OPNT003 to market.
With Opiant on course to complete the rolling submission in the second half of the year, BARDA has stepped up to provide funding for the preparation of the new drug application with the FDA.
“We greatly appreciate BARDA’s support for OPNT003,” Roger Crystal, M.D., Opiant president and CEO, said in a statement. “The worsening opioid overdose crisis, driven particularly by the ever-present threat of illicit synthetic opioids, such as fentanyl, underscores the need for overdose reversal treatment options.”