According to Opiant Pharmaceuticals, the National Institutes of Health’s National Institute on Drug Abuse (NIDA) has awarded the company a 3-year grant of about $7.4 million for development of OPNT003 intranasal nalmefene for the treatment of opioid overdose. The company will receive approximately $2.6 million for the first portion of the grant funding period, which will end on March 31, 2019.
Earlier this year, Opiant announced that it had positive data from a Phase 1 study, that it had met with the FDA regarding OPNT003, and that it planned to pursue a 505(b)(2) development path. The company says that it plans to submit an NDA for the nasal spray in 2020.
Opiant CEO Roger Crystal commented, “We view this NIDA grant as further validation of the potential for OPNT003 to be an important treatment for opioid overdose, a growing US health epidemic. Fentanyl was responsible for more overdose deaths (in excess of 20,000) than either heroin or prescription opioids in 2016. Recognizing the evolution of the opioid crisis, the National Institutes of Health has called for the development of stronger, longer-acting overdose reversal products in order to address this next wave of potent synthetic opioids, like fentanyl. We look forward to using this grant to continue the development of OPNT003.”
Chief Financial Officer David O’Toole said, “The receipt of this grant is reflective of our aim to maximize non-dilutive financing to support our research and development programs. Over the last five months, we have also announced the return of our royalty stream from Adapt Pharmaceuticals and the receipt of funds from the exercise of warrants, which have further strengthened our balance sheet.”
Adapt Pharma licensed Narcan naloxone nasal spray from Opiant (then called Lightlake Therapeutics) in 2014 and launched Narcan in the US in 2016.
Read the Opiant Pharmaceuticals press release.
