The proposed SBIR Phase II project aims at developing a new drug product, the naltrexone orally dissolving film (ODF), for treatment of alcohol dependence. The naltrexone ODF is a small, thin, and flexible film, containing naltrexone hydrochloride and other excipients. It is applied intra-orally and adheres to the oral mucosa to affect a rapid onset of action due to oral mucosal absorption, followed by an extended pharmacological action. The naltrexone ODF is administered 30 to 60 minutes prior to a drinking episode or as-needed when alcohol craving occurs. The naltrexone ODF is novel, cost- effective, convenient to use, dissolves in the mouth without the need for water and fills the gaps of current treatment regimens and market needs. Phase I of this project was highly successful wherein the specific aims were met in demonstrating the feasibility of developing a prototype naltrexone ODF formulation which met the targeted milestone having optimal functional properties. The Phase II program will extend to product development/ early-commercialization phase by validating the prototype formulation with IND-enabling safety studies, technology transfer and scale-up and manufacturing of clinical supplies. PROBLEM/OPPORTUNITY: Naltrexone is an approved drug for treatment of alcohol and opioid dependence. There are two naltrexone drug products marketed for treatment of alcohol dependence: oral tablets and injectable depot formulation. The former suffers from low bioavailability, poor patient compliance, and significant side effects. The later overcomes bioavailability and patient compliance issues but is expensive, inconvenient and has injection site reaction. The proposed naltrexone ODF drug product is expected to overcome the poor oral bioavailability of the oral naltrexone tablets, and the high cost and inconvenience of the injectable naltrexone depot formulations. The alcohol dependence medication market sector is under-served and has substantial potential. The proposed ODF technology could be extended and developed into improved dosage forms for other drugs targeted at treatment of substance-addiction. PLAN OUTLINE:
The aims of this proposed SBIR Phase II program on the naltrexone ODF are to: 1) manufacture preclinical supplies, 2) conduct preclinical studies, 3) technology transfer, scale-up and manufacture Phase 1 clinical supplies, and 4) prepare regulatory (CMC) documentation for a pre-IND (Investigational New Drug) meeting. Upon successful completion of this program, a SBIR Phase III follow-up program is proposed that will include filing of IND and conducting the Phase I clinical safety/proof-of-concept study.

Public Health Relevance

The proposed new product, naltrexone orally dissolving film (ODF), is expected to result in improved efficacy and better compliance in the pharmacological therapies for alcohol dependence. This will reduce the public health burden of heavy drinking to our society and significantly reduce related healthcare costs. In addition, the proposed technology is a platform that could be extended and developed into improved dosage forms for other substance abuse medications.

National Institute of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
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Special Emphasis Panel (ZRG1-IMST-A (12))
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Litten, Raye Z
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Bionex Pharmaceuticals, LLC
East Brunswick
United States
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