Addiction Experts Highlight the Need for Non-Abstinence-Based Therapies to Treat Alcohol Use Disorder in Adial Pharmaceuticals Key Opinion Leader Webinar

Adial Pharmaceuticals, Inc. 

(NASDAQ: ADIL)

 (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, recently hosted a virtual key opinion leader webinar with addiction experts Joseph Volpicelli, M.D., Ph.D., Executive Director and Founder of the Volpicelli Center; and Jonathan Hunt-Glassman, MBA, Chief Executive Officer and Co-founder of Oar Health, to discuss alcohol use disorder (AUD), the current treatment landscape, and the need for non-abstinence-based therapeutics. Both experts are nationally recognized for their efforts in providing improved treatment options to patients with AUD.

According to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and other published research:

• AUD is a medical condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, and health consequences.1
• 28.6 million adults ages 18 and older had AUD in 2021.2
• An estimated 894,000 adolescents ages 12 to 17 had AUD in 2021.2
• Over 140,000 people die from alcohol-related causes annually, making alcohol the fourth-leading preventable cause of death in the United States.1

The key opinion leaders emphasized that there is a substantial patient need for medications to treat AUD, yet current medications are not being prescribed or utilized by most treating physicians. There are only three FDA-approved medications for the treatment of AUD, and of the approximately 30 million individuals with AUD, only about 0.1% are given a prescription for one of these medications. Among the patients in treatment with these medications, adherence is a significant concern, with side effects being a common reason given for stopping the medication.

To improve engagement in medical treatment, the key opinion leaders expressed the belief that barriers to treatment could be reduced by giving people additional options such as non-abstinence-based therapies. A non-abstinence-based treatment approach will provide patients with the power to choose more realistic goals of reducing alcohol consumption rather than abstinence. Reductions in excessive drinking, even without complete abstinence, can have a major public health impact on morbidity and mortality associated with AUD.

“In the AUD treatment community, there is a strong bias that abstinence is the only legitimate goal. However, the academic community has shown that non-abstinence-based approaches lead to very beneficial results,” said Dr. Volpicelli. “Reduction in heavy drinking is associated with improvements in day-to-day functioning, socialization with peers, physical function, and self-esteem. Recovery is more than abstinence. Recovery is about doing better in life.”

“The biggest problem is that people don’t have access to treatments that work for them,” said Mr. Hunt-Glassman. “For some patients, currently available tools with the goal of lifelong abstinence work terrifically, for others, these tools are inconsistent with their goals and, consequently, may be a deterrent to getting treatment. For many patients, the goal is moderation rather than full sobriety. In other chronic disorders, there are several classes of medications available to meet patients’ needs, whereas for AUD we are limited to only a few options, making it difficult to match patients with the best options that match their goals and needs.”

Both Dr. Volpicelli and Mr. Hunt-Glassman acknowledged the strides the research community is making towards recognizing non-abstinence-based end goals for AUD treatment modalities, including the NIAAA’s recent updates to the research definition of ‘recovery.’ They are optimistic that as physicians’ understanding of addiction continues to grow and evolve, there will be a shift away from the all-or-nothing approach currently applied to treating AUD. They believe that with this shift, physicians will be more empowered to recommend a broader spectrum of treatments, better tailored to meet patients’ needs.

For more comments from Dr. Volpicelli and Mr. Hunt-Glassman, a recording of the event is available on Adial’s LinkedIn page:https://www.linkedin.com/events/exploringtheunmetneedinalcoholu7112901068706996224/theater/

1https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/understanding-alcohol-use-disorder2SAMHSA, Center for Behavioral Health Statistics and Quality. 2021 National Survey on Drug Use and Health. Tables 5.6A & 5.6B.

About Adial Pharmaceuticals, Inc.Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes (estimated to be approximately one-third of the AUD population) identified using the Company’s companion diagnostic genetic test. ONWARD showed promising results in reducing drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com.

Forward Looking Statements

This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding the need for non-abstinence-based options being paramount, non-abstinence-based treatment providing patients with the power to choose more realistic goals of reducing alcohol consumption rather than abstinence, the treatment having a major public health impact on morbidity and mortality associated with AUD, there being a shift away from the all-or-nothing approach currently applied to treating AUD as physicians’ understanding of addiction continues to grow and evolve, there will be a shift away from the all-or-nothing approach currently applied to treating AUD, physicians being more empowered to recommend a broader spectrum of treatments better tailored to meet patients’ needs and the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to advance ongoing partnering discussions, our ability to execute on our business strategy and bring AD04 to large markets in the most cost-effective and timely manner, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to retain our key employees or maintain our Nasdaq listing, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements and the continued maintenance and growth of our patent estate. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2022, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.

Contact:Crescendo Communications, LLC                        David Waldman / Alexandra Schilt                        Tel: [phone]                                Email: [e-mail]