News Release Details
Opiant Pharmaceuticals Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for OPNT003, Nasal Nalmefene, for the Treatment of Opioid Overdose
- Company expects to complete submission of the NDA using the 505(b)(2) pathway, as previously agreed upon with the FDA, in the second half of 2022
An estimated record 80,816 Americans died of an opioid overdose in 2021, a 17% increase over 2020 and a 62% increase from 2019, according to new data from the
“The opioid epidemic has evolved with the widening threat from potent synthetic opioids like fentanyl and there is significant evidence indicating that a new treatment option is needed,” said Roger Crystal, M.D., President and Chief Executive Officer of Opiant. “We believe the results from the pharmacokinetic (PK) and pharmacodynamic (PD) studies, in which OPNT003 demonstrated fast, strong, and long-lasting action and a well-tolerated safety profile, support OPNT003 as a potential new treatment option for opioid overdose. We look forward to working with the FDA to complete this rolling submission for OPNT003, nasal nalmefene, and we will provide an update when the NDA is completed.”
Opiant was granted Fast Track designation for OPNT003, nasal nalmefene, in
This project has been funded in whole or in part with federal funds from the
About OPNT003, nasal nalmefene
OPNT003, nasal nalmefene, is a high-affinity mu-opioid receptor antagonist that reduces the binding of opioids to this receptor, limiting respiratory depression, the primary cause of overdose injury and death. In a head-to-head pharmacodynamic study, OPNT003 produced a reversal of remifentanil-induced respiratory depression that was nearly twice that produced by NARCAN® Nasal Spray at the primary endpoint of five minutes. The intrinsic properties of nalmefene, taken together with results from Opiant pharmacokinetic and pharmacodynamic studies, are consistent with the potential of OPNT003 to provide fast, strong, and sustained reversal of opioid overdose.
About Opiant Pharmaceuticals, Inc.
This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements, and among other things, completion of the NDA filing in the second half of 2022. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "would," "expects," "plans," "intends," "anticipates," "believes," "estimates," "predicts," "projects," "potential," or "continue" or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. Additional factors that could materially affect actual results can be found in our Form 10-K for the year ended December 31, 2021 and our Form 10-Q for the quarter ended
For Media and Investor Inquiries:
- Ahmad FB, Rossen LM, Sutton P. Provisional drug overdose death counts.
National Center for Health Statistics. 2022.
- Hedegaard H, Miniño AM, Spencer MR,
Warner M. Drugoverdose deaths in the United States, 1999–2020. NCHS Data Brief, no 428. Hyattsville, MD: National Center for Health Statistics. 2021.
Source: Opiant Pharmaceuticals, Inc.