News Release Details
Opiant Pharmaceuticals Announces Additional $2.1 Million Funding Under BARDA Contract for OPNT003, Nasal Nalmefene
“We greatly appreciate BARDA’s support for OPNT003,” said Roger Crystal, M.D., President and Chief Executive Officer of Opiant. “The worsening opioid overdose crisis, driven particularly by the ever present threat of illicit synthetic opioids, such as fentanyl, underscores the need for overdose reversal treatment options.”
A record number of people in
OPNT003, a nasal formulation containing the high affinity opioid antagonist, nalmefene, was studied in three clinical trials: a pharmacokinetic (PK) study comparing OPNT003 to an intramuscular nalmefene injection, a second PK study comparing a single intranasal dose to a single dose in each nostril or two doses in a single nostril, and a pharmacodynamic (PD) study comparing nasal nalmefene to nasal naloxone in reversing opioid-induced respiratory depression. The PK studies demonstrated rapid absorption and higher plasma concentrations versus intramuscular injection.3,4 In the PD study, OPNT003 met the primary endpoint of non-inferiority to nasal naloxone, producing a reversal in remifentanil-induced respiratory depression that was nearly twice that produced by nasal naloxone at five minutes.5 Opiant has initiated rolling submission of an NDA to the FDA for OPNT003 using the 505(b)(2) pathway and intends to complete the filing in the second half of 2022. OPNT003 was granted Fast Track Designation in
Earlier awards from BARDA for
BARDA is part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. This project has been funded in whole or in part with federal funds from the
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:
1. Ahmad FB, Rossen LM, Sutton P. Provisional drug overdose death counts.
2. Skolnick P. Treatment of overdose in the synthetic opioid era. Pharmacology & Therapeutics. 2022.
3. ClinicalTrials.gov Identifier: NCT04759768
4. ClinicalTrials.gov Identifier: NCT05219669
5. ClinicalTrials.gov Identifier: NCT04828005
Source: Opiant Pharmaceuticals