Opiant Pharmaceuticals Announces Notice of Allowance for U.S. Patent With Claims Covering OPNT003 for the Treatment of Opioid Overdose
August 02 2022 - 04:05PM
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.
About Intravail®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.
Forward-Looking StatementsThis 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.
For Media and Investor Inquiries:Ben Atkins, Opiant(310)
598-5410batkins@opiant.com
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