UG3DA057853

Naltrexone Transdermal Patch - An Accessible, Patient-Focused Option to Treat OUD Relapse

The U.S. remains firmly in the grip of a progressive opioid crisis of addiction and overdose. In 2019, nearly 50,000 people died of an opioid overdose, and an estimated 3 million people have opioid use disorder (OUD). Libero Pharma's program to develop a Naltrexone Transdermal Patch will address multiple health objectives by providing new prevention and treatment alternatives, optimizing current medication-assisted therapy, and improving access to treatment.

The antagonist Naltrexone is one of only three medications with proven benefit in OUD relapse prevention. However, with poor tolerance and compliance in oral form, intramuscular (IM) Naltrexone is the only viable antagonist option in the OUD population. Despite being approved in 2010, it is prescribed to fewer than 30,000 patients in the U.S. annually. Patient uptake is limited by availability, mode of administration (nurse-administered 4ml deep gluteal injection), cost, and low adherence.

Libero has assembled a highly experienced team to bring to market a novel Naltrexone Transdermal Patch (NNTP), which shares the benefits of IM Naltrexone in that it is non-addictive and avoids first-pass metabolism and the resultant intolerance. As well as an easy-to-use alternative in OUD relapse prevention, NNTP also offers an accessible and undaunting option both for stable patients looking to take the final step away from chronic agonist use and off-drug patients struggling with cravings at risk of relapse.

The NNTP would eliminate the administrative burden, patient discomfort, and cost barriers that currently limit the use of IM Naltrexone. This presents a genuine opportunity for widespread NNTP use in primary care, where a vast and growing opioid-dependent population urgently requires care.

This program has been informed by clear input from the FDA, both in terms of plasma Naltrexone level requirements and the required regulatory steps. Libero will pursue a 505(b)(2) pathway to bring NNTP to market for OUD relapse prevention. The UG3 phase will include IND-enabling activities to secure an FDA issuance of an IND. The UH3 phase will evaluate efficacy and safety of the NNTP in a multi-site, double-blind, randomized controlled trial against the IM Naltrexone comparator over 6 months.

Libero Pharma

TO SUPPORT BASIC AND CLINICAL NEUROSCIENCE, BIOMEDICAL, BEHAVIORAL AND SOCIAL SCIENCE, EPIDEMIOLOGIC, HEALTH SERVICES AND HEALTH DISPARITY RESEARCH. TO DEVELOP NEW KNOWLEDGE AND APPROACHES RELATED TO THE PREVENTION, DIAGNOSIS, TREATMENT, ETIOLOGY, AND CONSEQUENCES OF DRUG ABUSE AND ADDICTION, INCLUDING HIV/AIDS. TO SUPPORT RESEARCH TRAINING AND RESEARCH SCIENTIST DEVELOPMENT. TO SUPPORT DISSEMINATION OF RESEARCH FINDINGS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) LEGISLATION IS INTENDED TO EXPAND AND IMPROVE THE SBIR PROGRAMS TO EMPHASIZE AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF TECHNOLOGY DEVELOPED THROUGH FEDERAL SBIR RESEARCH AND DEVELOPMENT, INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN THE SBIR PROGRAM. THE LEGISLATION INTENDS THAT THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.279 - Drug Abuse and Addiction Research Programs

National Institute on Drug Abuse (NIDA) [HHS - NIH]

United Kingdom

Foreign

Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional) (PAR-20-092)

Amendment Since initial award the End Date has been extended from 08/31/24 to 08/31/26 and the total obligations have increased 99% from $3,187,507 to $6,351,015.