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SANTA MONICA, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (Opiant) (NASDAQ: OPNT) today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 16/461,354, with formulation and method of use claims around OPNT003, the Company’s investigational treatment for opioid overdose. The allowed patent application, entitled, “Compositions and Methods for the Treatment of Opioid Overdose,” includes claims covering combinations of nalmefene and Intravail® in a nasal formulation.
Opiant expects this patent to issue within the next few months and to have a patent term extending to 2037. A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The Company also expects this patent to be listed in the U.S Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, if it receives market approval.
"The issuance of a U.S. notice of allowance is a significant additional step forward for OPNT003 and further enhances its value by protecting the innovation behind its development. We look forward to building on this important milestone by further protecting our intellectual property,” said Roger Crystal, M.D., President and Chief Executive Officer of Opiant.
OPNT003, a nasal formulation containing the high affinity opioid antagonist, nalmefene, is an investigational treatment for opioid overdose. OPNT003 was studied in three clinical trials: a pharmacokinetic (“PK”) study comparing this nasal nalmefene formulation to an intramuscular nalmefene injection, a second PK study comparing a single intranasal nalmefene dose to a single dose in each nostril or two doses in a single nostril, and a pharmacodynamic study comparing nasal nalmefene to nasal naloxone in reversing opioid-induced respiratory depression. All three studies met their primary endpoint. Opiant has initiated rolling submission of a New Drug Application 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 November 2021.
Intravail, ProTek, and Hydrogel, and the Intravail, ProTek, and Hydrogel logos are trademarks or registered trademarks of Aegis Therapeutics, LLC. Aegis Therapeutics, LLC. is a wholly-owned subsidiary of Neurelis, Inc.
About Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose. For more information visit: www.opiant.com.
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 March 31,2022, filed with the Securities and Exchange Commission on March 4, 2022 and May 10, 2022, respectively, including under the caption titled "Risk Factors." These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.
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