OPNET: Opnet Technologies, Inc. (OPNT) Reports Development of OPNT003 for Treatment of Opioid Overdose

Opiant Pharmaceuticals, Inc. (NASDAQ: OPNT) 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 was previously approved by the FDA for treating suspected or confirmed opioid overdose. The 505(b)(2) pathway allows companies to rely in part on the FDA's findings of safety and efficacy of a previously approved product and to supplement these findings with a more limited set of their own studies to satisfy FDA requirements, as opposed to conducting the full array of preclinical and clinical studies that would typically be required.