Opiant Pharmaceuticals Announces Notice of Allowance for U.S. Patent With Claims Covering OPNT003 for the Treatment of Opioid Overdose
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 pharmacodynaic 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.
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