Opiant Pharmaceuticals has received an additional $3 million from a 3-year grant awarded in 2018 by the National Institutes of Health’s (“NIH”) National Institute on Drug Abuse (“NIDA”) to support development of OPNT003 intranasal nalmefene for the treatment of opioid overdose. The company previously received $2.6 million from the grant, which is worth up to a total of $7.4 million.
According to Opiant, the company intends to submit an NDA for OPNT003 in 2020, using the 505(b)(2) development pathway. Opiant has already announced that Consort Medical subsidiaries Aesica and Bespak will manufacture the product if the NDA is approved.
Opiant CEO Roger Crystal said, “The award of this second tranche validates the progress we have achieved to date with OPNT003. We will use these funds in 2019 to advance the program, including conducting a pivotal pharmacokinetic study. The development of stronger, longer-acting opioid overdose reversal products that potentially better address the next wave of potent synthetic opioids, like fentanyl, remains a critical area of focus for the NIH, and we are appreciative of their continued support.”
Read the Opiant Pharmaceuticals press release.
