Opiant Pharmaceuticals Announces Notice of Allowance for U.S. Patent with Claims Covering OPNT004 for the Treatment of Cannabinoid Hyperemesis Syndrome

Rhea-AI Summary

Opiant Pharmaceuticals (NASDAQ: OPNT) announced a Notice of Allowance from the USPTO for OPNT004 (drinabant), aimed at treating cannabinoid hyperemesis syndrome (CHS). This significant step indicates that the patent for a parenteral formulation of drinabant will likely be granted soon, anticipated to expire no earlier than 2040. The company believes that the rising use of cannabis due to legalization may increase CHS cases, thereby creating a market for OPNT004, which is expected to enter Phase I studies in 2023.

Positive

• Notice of Allowance for OPNT004 indicates potential patent grant, enhancing market exclusivity until at least 2040.
• Expected rise in cannabis use may lead to increased demand for OPNT004, targeting a specific medical issue.
• Opiant plans to initiate Phase I studies for OPNT004 in 2023, progressing its development pipeline.

Negative

• None.

SANTA MONICA, Calif., Aug. 22, 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 Allowance for Opiant’s pipeline candidate OPNT004 (drinabant) for the treatment of cannabinoid hyperemesis syndrome (CHS), a condition among cannabis users that leads to repeated and severe bouts of vomiting. A Notice of Allowance is issued after the USPTO decides that a patent can be granted from an application.

"This patent allowance is welcome news, and a testament to our commitment of bringing innovative science to the treatment of addictions and drug overdose,” said Roger Crystal, M.D., President and Chief Executive Officer of Opiant. “With the consumption of cannabis increasing, due in large part to the legalization of its recreational use, we are developing OPNT004 in anticipation that emergency departments may receive more and more cases of side effects related to chronic or heavy use.¹ Drinabant is being developed as an injection, which is ideal for these patients, who have frequent bouts of intractable nausea and vomiting that are generally unresponsive to traditional anti-emetics.”

The USPTO issued a Notice of Allowance for U.S. Patent Application 16/904,359, entitled “Compositions and methods for treating cannabinoid hyperemesis syndrome with a cannabinoid receptor antagonist” for OPNT004. This patent covers OPNT004 as a method of treatment for CHS using drinabant administered as a parenteral formulation. Opiant expects this patent to issue within the next few months and expire no earlier than 2040. 

About OPNT004
OPNT004 (drinabant) is a high affinity, CB-1 antagonist for the treatment of excessive cannabinoid use. Cannabinoids are compounds found in the cannabis plant or made synthetically, that bind to cannabinoid receptors found in the central nervous system, gastrointestinal tract and immune system. With support from the National Center for Advancing Translational Sciences (NCATS), Opiant is developing a formulation for the parenteral administration of OPNT004 for the potential treatment of cannabinoid-related toxicities, which include cannabinoid hyperemesis syndrome (CHS) and acute cannabinoid overdose (ACO), a condition when excessive tetrahydrocannabinol (THC) can cause anxiety, paranoia, visual and auditory hallucinations, and nausea. There are currently no FDA approved therapeutics for either CHS or ACO. Opiant expects to initiate Phase I studies for OPNT004 in 2023. Opiant is developing drinabant under a license from Sanofi-Aventis.

About cannabis hyperemesis syndrome (CHS)
Cannabinoid hyperemesis syndrome (CHS) is a syndrome of cyclic vomiting associated with cannabis use. While the onset of symptoms is sudden, CHS occurs in people who use cannabis regularly, and has been linked to long term cannabis use. People with CHS experience reoccurring episodes of nausea, vomiting, dehydration, and abdominal pain, which can result in frequent visits to the emergency department. The condition is generally unresponsive to traditional anti-emetics, which are medications used to prevent or treat nausea and vomiting. However, CHS can lead to health complications if left untreated. Only a small portion of people who regularly use cannabis develop CHS. Because CHS was first described in the medical literature less than 20 years ago, many people may have it and either not report it or are misdiagnosed. One analysis found that CHS was responsible for up to 6% of patients who visited the emergency room for vomiting.²

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 Statements
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, the completion of the development of OPNT004. 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 June 30, 2022, filed with the Securities and Exchange Commission on March 4, 2022, and August 11, 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) 598-5410
batkins@opiant.com

1. The United Nations World Drug Report 2022; Press Release: https://www.unodc.org/unodc/en/frontpage/2022/June/unodc-world-drug-report-2022-highlights-trends-on-cannabis-post-legalization--environmental-impacts-of-illicit-drugs--and-drug-use-among-women-and-youth.html
2. Simonetto DA, Oxentenko AS, Herman ML, Szostek JH. Cannabinoid hyperemesis: a case series of 98 patients. Mayo Clin Proc. 2012 Feb;87(2):114-9. doi: 10.1016/j.mayocp.2011.10.005. PMID: 22305024; PMCID: PMC3538402.

FAQ

What is the latest update on OPNT004 by Opiant Pharmaceuticals?

Opiant Pharmaceuticals received a Notice of Allowance from the USPTO for OPNT004, which is set to treat cannabinoid hyperemesis syndrome.

When will Opiant initiate Phase I studies for OPNT004?

Opiant expects to begin Phase I studies for OPNT004 in 2023.

What is cannabinoid hyperemesis syndrome (CHS)?

CHS is a condition linked to regular cannabis use, causing severe bouts of vomiting that are often unresponsive to traditional treatments.

How does the patent for OPNT004 impact Opiant Pharmaceuticals?

The patent allowance for OPNT004 bolsters Opiant's market position by ensuring potential exclusivity in treating CHS for years to come.