Initial $500,000 to be Utilized to Advance the Development of OPNT003
SANTA MONICA, Calif., June 25, 2018 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ: OPNT ), a specialty pharmaceutical company developing pharmacological treatments for addictions, announced today that it has received the first tranche of $500,000 from the previously awarded grant of approximately $7.4 million from the National Institutes of Health’s National Institute on Drug Abuse for the development of OPNT003 (intranasal nalmefene), a long-lasting opioid antagonist for the treatment of opioid overdose.
These initial funds will be used to advance the development of an OPNT003 formulation. The Company previously announced encouraging data from a Phase I clinical study of OPNT003 and subsequently conducted a meeting with the U.S. Food & Drug Administration (“FDA”). Based on FDA feedback, Opiant intends to pursue a 505(b)(2) development path and anticipates the potential to submit a New Drug Application (“NDA”) for the drug and intranasal delivery device combination in 2020.
“We are pleased to receive these initial funds from the NIH and are preparing to conduct key formulation studies of OPNT003,” said Roger Crystal, M.D., Chief Executive Officer of Opiant. “Following completion of the formulation studies, we intend to initiate a confirmatory pharmacokinetic study which would position us to potentially submit an NDA for OPNT003 and intranasal delivery device combination, in 2020. Based on the data generated to date, we believe OPNT003 will have a substantially longer half-life than naloxone, which has been previously approved by the FDA for treating suspected or confirmed opioid overdose. The development of stronger, longer-acting overdose reversal products that address the next wave of potent synthetic opioids, like fentanyl, is a critical area of focus for the NIH, and we are excited to continue advancing our studies of OPNT003.”
The NIH grant includes approximately $2.6 million to be funded for the period ending March 31, 2019, with the balance to be funded over the subsequent two years.
About Opiant Pharmaceuticals, Inc. Opiant Pharmaceuticals, Inc. is a specialty pharmaceutical company developing pharmacological treatments for addictions. The National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), describes these disorders as chronic relapsing brain diseases which burden society at both the individual and community levels. With its innovative opioid antagonist nasal delivery technology, Opiant is positioned to become a leader in these treatment markets. Opiant's first product, NARCAN® Nasal Spray, is approved for marketing in the U.S. and Canada by its partner, Adapt Pharmaceuticals. For more information please visit: www.opiant.com .
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