SANTA MONICA, Calif., April 01, 2019 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ: OPNT), a specialty pharmaceutical company developing medicines for addictions and drug overdose, has been awarded the second tranche of $3.0 million from the total grant of approximately $7.4 million from the National Institutes of Health’s (“NIH”) National Institute on Drug Abuse (“NIDA”) for the development of OPNT003, nasal nalmefene, a long-acting opioid antagonist for the treatment of opioid overdose.
Based on feedback from the U.S. Food and Drug Administration, Opiant intends to pursue a 505(b)(2) development path and anticipates the potential to submit a New Drug Application for the drug and intranasal delivery device combination in 2020.
“The award of this second tranche validates the progress we have achieved to date with OPNT003,” said Roger Crystal, M.D., Chief Executive Officer of Opiant. “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.”
The NIH grant includes approximately $5.6 million to be funded through March 31, 2020, with the balance of the approximately $7.4 million to be funded in the period beginning April 1, 2020, subject to available government funds and continued progress of the development program.
The Company also announced that Phil Skolnick, Ph.D., D.Sc. (hon.), Opiant’s Chief Scientific Officer, will participate in a symposium entitled, “Addressing the Opioid Epidemic Through Science and Policy,” at the 2019 Experimental Biology meeting taking place April 6-9, 2019, in Orlando. Dr. Skolnick will give a talk entitled, “Fighting Fire with Fire: Development of Intranasal Nalmefene to Treat Synthetic Opioid Overdose.” The symposium, hosted by the American Society of Pharmacology & Experimental Therapeutics, will take place on April 7 from 8-10 a.m., EST. Further details are available at https://www.aspet.org/aspet/meetings-awards/meetingsannual-meeting/aspet-annual-meeting-at-eb-2019/program/session-detail/addressing-the-opioid-epidemic-through-science-and-policy-39-19.
About Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc. is a specialty pharmaceutical company developing medicines for addictions and drug overdose. NIDA, a division of the NIH, describes addictive disorders as chronic relapsing brain diseases which burden society at both the individual and community levels. Opiant's first drug overdose product, NARCAN® Nasal Spray, is was licensed to Adapt Pharmaceuticals, now owned by Emergent BioSolutions, Inc. For more information visit: www.opiant.com.
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Source: Opiant Pharmaceuticals, Inc.