Opiant Pharmaceuticals Announces Development of OPNT003, Intranasal Nalmefene, for Treatment of Opioid Overdose
Opiant Pharmaceuticals, Inc. (OPNT)
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Source: GlobeNewswire
Based on FDA Feedback, Opiant Intends to Pursue 505 (b)(2) Development Pathway Opiant Anticipates Submitting an NDA for this Product Candidate in 2020 SANTA MONICA, Calif., Feb. 12, 2018 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT), a specialty pharmaceutical company developing pharmacological treatments for addictions, today announced positive data from a Phase I clinical study of its product candidate OPNT003 (intranasal nalmefene), and provided an update on a meeting held February 8, 2018 with the U.S. Food and Drug Administration (FDA) regarding its planned development program. OPNT003 is in development as a long-lasting opioid antagonist for the treatment of opioid overdose. Based on feedback from the FDA in connection with this meeting, 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. Nalmefene for injection
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