SANTA MONICA, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) — Opiant Pharmaceuticals, Inc. (Opiant) (NASDAQ: OPNT) today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of US Patent Application No. 16/461,354, with formulation and method of use claims surrounding OPNT003, the company’s investigational treatment for opioid overdose. The granted 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 through 2037. A Notice of Allowance is issued after the USPTO determines that a patent can be granted on request. The Company also expects this patent to be listed in the U.S. Food and Drug Administration (FDA) Approved Pharmaceuticals with Therapeutic Equivalence Assessments, or Orange Book, if granted clearance. of placing on the market.
“The issuance of a clearance notice in the United States is an important additional step for OPNT003 and further enhances its value by protecting the innovation behind its development. We look forward to continuing on this important milestone by further protecting our intellectual property,” said Roger Crystal. , MD, President and CEO of Opiant.
OPNT003, a nasal formulation containing the high-affinity opioid antagonist nalmefene, is an investigational treatment for opioid overdose. OPNT003 has been studied in three clinical trials: a pharmacokinetic (“PK”) study comparing this nasal formulation of nalmefene to an intramuscular injection of nalmefene, a second PK study comparing a single intranasal dose of nalmefene to a single dose in each nostril or two single-nostril doses, and a pharmacodynamic study comparing nasal nalmefene to nasal naloxone for reversing opioid-induced respiratory depression. All three studies met their primary endpoint. Opiant has initiated the ongoing 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 has been 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 drugs to fight addictions and drug overdoses. 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 could cause our actual results, levels of activity, performance or achievements to be materially different. future results, levels of activity, performance or achievements expressed, implied or inferred by such forward-looking statements, and among other things, the completion of the filing of the NDA during the second half of 2022. In certain instances, you may identify forward-looking statements by terminology such as “may”, “will”, “should”, “could”, “will”, “expect”, “plan”, “intend”, “anticipate” , “believes”, “estimates”, “predicts”, “projects”, “potential”, or “continues” or the negative of these and other comparable terms. These statements are only predictions based on our expectations. and current projections regarding events future events. You should not place undue reliance on these statements. Actual events or results may differ materially. When evaluating these statements, you should specifically consider various factors. Other 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 three months 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 statements. We undertake no obligation to update forward-looking statements after the date of this press release to conform them to reflect the occurrence of unforeseen events, except as required by applicable law.
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Ben Atkins, Opiant