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Adial Pharmaceuticals Commends the National Institute on Alcohol Abuse and Alcoholism's New Definition of Recovery

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Adial Pharmaceuticals (NASDAQ: ADIL) commends the National Institute on Alcohol Abuse and Alcoholism (NIAAA) for its updated definition of recovery, which now includes non-abstinence solutions. This aligns with Adial's AD04 program for alcohol use disorder (AUD), which offers patients flexibility in reducing drinking and/or achieving abstinence.

The NIAAA's new definition, emphasized in its 2025 Professional Judgement Budget, recognizes that effective recovery solutions can focus on harm reduction and improved quality of life. This shift validates Adial's approach and potentially broadens its commercial and government market potential.

Cary Claiborne, CEO of Adial Pharmaceuticals, stated that AD04 is uniquely positioned to provide a therapeutic option for those seeking reduction in alcohol use or complete abstinence. The company is optimistic that NIAAA's new perspective will stimulate additional support for programs like AD04 in both commercial and government sectors.

Adial Pharmaceuticals (NASDAQ: ADIL) elogia il National Institute on Alcohol Abuse and Alcoholism (NIAAA) per la sua definizione aggiornata di recupero, che ora include soluzioni non basate sull'astinenza. Questo è in linea con il programma AD04 di Adial per i disturbi legati all'uso di alcol (AUD), che offre ai pazienti flessibilità nel ridurre il consumo di alcol e/o nel raggiungere l'astinenza.

La nuova definizione del NIAAA, evidenziata nel suo Budget Professionale per il Giudizio 2025, riconosce che le soluzioni efficaci per il recupero possono concentrarsi su riduzione del danno e miglioramento della qualità della vita. Questo cambiamento avvalora l'approccio di Adial e potenzialmente amplia il suo potenziale di mercato commerciale e governativo.

Cary Claiborne, CEO di Adial Pharmaceuticals, ha dichiarato che AD04 è posizionato in modo unico per fornire un'opzione terapeutica a coloro che cercano una riduzione nell'uso di alcol o un'astinenza completa. L'azienda è ottimista che la nuova prospettiva del NIAAA stimolerà un ulteriore supporto per programmi come AD04 nei settori commerciale e governativo.

Adial Pharmaceuticals (NASDAQ: ADIL) elogia al National Institute on Alcohol Abuse and Alcoholism (NIAAA) por su definición actualizada de recuperación, que ahora incluye soluciones no basadas en la abstinencia. Esto está alineado con el programa AD04 de Adial para el trastorno por consumo de alcohol (AUD), que brinda a los pacientes flexibilidad para reducir el consumo de alcohol y/o alcanzar la abstinencia.

La nueva definición del NIAAA, enfatizada en su Presupuesto de Juicio Profesional 2025, reconoce que las soluciones efectivas de recuperación pueden centrarse en reducción de daños y mejora de la calidad de vida. Este cambio valida el enfoque de Adial y potencialmente amplía su potencial de mercado comercial y gubernamental.

Cary Claiborne, CEO de Adial Pharmaceuticals, declaró que AD04 está posicionado de manera única para proporcionar una opción terapéutica para aquellos que buscan reducir el uso de alcohol o lograr una abstinencia completa. La empresa es optimista de que la nueva perspectiva del NIAAA estimulará un apoyo adicional para programas como AD04 en los sectores comercial y gubernamental.

Adial Pharmaceuticals (NASDAQ: ADIL)는 NIAAA(국립 알코올 남용 및 알코올 중독 연구소)가 회복의 새로운 정의를 제정한 것을 높이 평가하며, 이 정의에는 이제 비금주 솔루션이 포함됩니다. 이는 Adial의 AD04 프로그램과 일치하여 알코올 사용 장애(AUD) 환자에게 음주를 줄이거나 금주를 달성하는 데 유연성을 제공합니다.

NIAAA의 새로운 정의는 2025 전문 판단 예산에서 강조되었으며, 효과적인 회복 솔루션은 해악 감소와 삶의 질 향상에 초점을 맞출 수 있음을 인식합니다. 이러한 변화는 Adial의 접근 방식을 검증하고 잠재적으로 상업 및 정부 시장의 잠재력을 확대합니다.

Adial Pharmaceuticals의 CEO인 Cary Claiborne은 AD04가 음주 감소 또는 완전 금주를 원하는 사람들에게 치료 옵션을 제공할 수 있는 독특한 위치에 있다고 말했습니다. 회사는 NIAAA의 새로운 관점이 AD04와 같은 프로그램에 대해 상업 및 정부 부문에서 추가 지원을 촉진할 것이라고 낙관하고 있습니다.

Adial Pharmaceuticals (NASDAQ: ADIL) félicite le National Institute on Alcohol Abuse and Alcoholism (NIAAA) pour sa définition mise à jour de la récupération, qui inclut désormais des solutions non basées sur l'abstinence. Cela est en accord avec le programme AD04 d'Adial pour les troubles liés à l'usage de l'alcool (AUD), qui offre aux patients la flexibilité de réduire leur consommation d'alcool et/ou d'atteindre l'abstinence.

La nouvelle définition du NIAAA, soulignée dans son Budget Professionnel Judiciaire 2025, reconnaît que les solutions de récupération efficaces peuvent se concentrer sur la réduction des risques et l'amélioration de la qualité de vie. Ce changement valide l'approche d'Adial et élargit potentiellement son potentiel de marché commercial et gouvernemental.

Cary Claiborne, PDG d'Adial Pharmaceuticals, a déclaré que l'AD04 est particulièrement bien placé pour offrir une option thérapeutique à ceux qui cherchent à réduire leur consommation d'alcool ou à obtenir une abstinence complète. L'entreprise est optimiste que la nouvelle perspective du NIAAA stimulera un soutien supplémentaire pour des programmes comme l'AD04 dans les secteurs commercial et gouvernemental.

Adial Pharmaceuticals (NASDAQ: ADIL) lobt das National Institute on Alcohol Abuse and Alcoholism (NIAAA) für seine aktualisierte Definition von Genesung, die nun nicht-abstinente Lösungen umfasst. Dies steht im Einklang mit Adials AD04-Programm für Alkoholmissbrauch (AUD), das den Patienten Flexibilität bei der Reduzierung des Alkoholkonsums und/oder beim Erreichen der Abstinenz bietet.

Die neue Definition des NIAAA, die im Berufsbudget 2025 betont wird, erkennt an, dass effektive Genesungslösungen sich auf Schadensverminderung und Verbesserung der Lebensqualität konzentrieren können. Dieser Wandel validiert Adials Ansatz und könnte das potenzielle kommerzielle und staatliche Marktpotenzial erweitern.

Cary Claiborne, CEO von Adial Pharmaceuticals, erklärte, dass AD04 in einzigartiger Weise in der Lage ist, eine therapeutische Option für diejenigen anzubieten, die eine Reduzierung des Alkoholgebrauchs oder vollständige Abstinenz anstreben. Das Unternehmen ist optimistisch, dass die neue Perspektive des NIAAA zusätzlichen支持 für Programme wie AD04 im kommerziellen und staatlichen Sektor anregen wird.

Positive
  • NIAAA's new definition of recovery aligns with Adial's AD04 program, potentially expanding market opportunities
  • AD04 offers flexibility in treatment, allowing for both reduction in drinking and abstinence
  • NIAAA's shift may stimulate additional support for programs like AD04 in commercial and government sectors
Negative
  • None.

Insights

The NIAAA's updated definition of recovery to include non-abstinence solutions is a significant shift in the approach to treating alcohol use disorder (AUD). This aligns well with Adial Pharmaceuticals' AD04 program, potentially expanding its market reach. The emphasis on harm reduction and improved quality of life, rather than solely focusing on abstinence, could lead to:

  • Increased acceptance of diverse treatment options
  • Broader patient base for AD04, as it caters to both reduction and abstinence goals
  • Potential for enhanced government support and funding

However, it's important to note that while this development is promising for Adial, the company is still in the clinical stage. The actual impact on revenue and market share remains to be seen, contingent on successful clinical trials and regulatory approvals. Investors should monitor AD04's progress through clinical phases and potential partnerships or government collaborations that may arise from this shift in treatment paradigm.

This news represents a positive market opportunity for Adial Pharmaceuticals. The NIAAA's updated definition could significantly expand the addressable market for AUD treatments like AD04. Key points to consider:

  • Potential increase in patient adoption rates due to more flexible treatment goals
  • Enhanced likelihood of insurance coverage and reimbursement for non-abstinence-based therapies
  • Possible acceleration of government funding for research and development in this area

However, investors should be cautious. Adial is a micro-cap company with a market capitalization of only $6.36 million, indicating high risk. The company's ability to capitalize on this opportunity will depend on its financial resources, clinical trial outcomes and ability to navigate the regulatory landscape. While the news is promising, it doesn't guarantee immediate financial success or market dominance for Adial.

AD04 Program Aligned with NIAAA's New Inclusion of Non-Abstinence Solutions, Validating Commercial and Government Market Potential

GLEN ALLEN, Va., Oct. 15, 2024 (GLOBE NEWSWIRE) -- 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, today applauded the National Institute on Alcohol Abuse and Alcoholism (NIAAA) for its newly updated definition of recovery. The new definition, outlined and emphasized in NIAAA’s 2025 Professional Judgement Budget (PJB) as reported to the U.S. Congress following an original introduction in an NIAAA PJB, emphasizes a broader, non-abstinence approach to recovery, which aligns directly with Adial’s AD04 program, which has the potential to offer patients the flexibility of reducing drinking and/or abstinence.

NIAAA’s updated definition underscores a growing clinical outcome goal and recognition that effective recovery solutions need not be solely abstinence based, opening the door to therapeutic options that focus on harm reduction and improved quality of life. AD04, Adial’s lead investigational product for alcohol use disorder (AUD), is designed to support patients seeking flexible treatment that could offer reduction in drinking and/or abstinence recovery paths, making it a promising candidate to meet the evolving market needs. This recognition and further emphasis in the FY 2025 Professional Judgement Budget by NIAAA is validation of Adial’s approach as meeting the NIAAA’s new standard for recovery, broadening Adial’s significant commercial and government market potential.

“AD04 is uniquely positioned to provide a therapeutic option for those seeking a reduction in alcohol use and/or complete abstinence,” said Cary Claiborne, CEO of Adial Pharmaceuticals. “With NIAAA’s focus shifting to include non-abstinence recovery approaches, we are optimistic that this will stimulate additional support for programs like AD04, not only within commercial markets but also from government initiatives. The alignment of AD04’s development and the NIAAA’s updated perspective offers a promising future for those suffering from AUD, providing them with more personalized, flexible treatment options.”

About Adial Pharmaceuticals, Inc.

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of addiction 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 identified using the Company’s proprietary companion diagnostic genetic test. ONWARD showed promising results in reducing heavy 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.

If you are interested in exploring partnership opportunities with Adial, we invite you to reach out to us (BD@adialpharma.com) to discuss how our joint efforts can bring about positive change in the millions of patients who are struggling with addiction.

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 AD04 supporting patients seeking flexible treatment that could offer reduction in drinking and/or abstinence recovery paths, making it a promising candidate to meet the evolving market needs, the recognition by NIAAA that effective recovery solutions need not be solely abstinence based broadening Adial’s significant commercial and government market potential, AD04 being uniquely positioned to provide a therapeutic option for those seeking a reduction in alcohol use and/or complete abstinence, NIAAA’s focus shifting to include non-abstinence recovery approaches stimulating additional support for programs like AD04, not only within commercial markets but also from government initiatives, the alignment of AD04’s development and the NIAAA’s updated perspective offering a promising future for those suffering from AUD, providing them with more personalized, flexible treatment options 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 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 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, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. 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, 2023, 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: 212-671-1020
Email: ADIL@crescendo-ir.com


FAQ

What is Adial Pharmaceuticals' (ADIL) response to NIAAA's new definition of recovery?

Adial Pharmaceuticals (ADIL) commends NIAAA's updated definition of recovery, which now includes non-abstinence solutions. This aligns with Adial's AD04 program for alcohol use disorder, potentially expanding its market opportunities.

How does Adial's AD04 program align with NIAAA's new recovery definition?

Adial's AD04 program aligns with NIAAA's new definition by offering patients flexibility in reducing drinking and/or achieving abstinence, focusing on harm reduction and improved quality of life for those with alcohol use disorder.

What potential impact could NIAAA's new recovery definition have on Adial Pharmaceuticals (ADIL)?

NIAAA's new recovery definition could potentially broaden Adial Pharmaceuticals' (ADIL) commercial and government market potential, and stimulate additional support for programs like AD04 in both commercial and government sectors.

What is the significance of NIAAA's 2025 Professional Judgement Budget for Adial Pharmaceuticals (ADIL)?

NIAAA's 2025 Professional Judgement Budget emphasizes the new non-abstinence approach to recovery, which validates Adial Pharmaceuticals' (ADIL) approach and potentially expands its market opportunities for its AD04 program.

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