Baclofen formulation for spasticity with dysphagia

DESCRIPTION (PROVIDED BY APPLICANT): Phase V Pharmaceuticals, Inc., develops lower cost alternatives for expensive drugs used in patients with central nervous system (CNS) injuries. The special needs of people with disabilities, in this case both impaired mobility due to spasticity and impaired feeding due to dysphagia, are often overlooked. This project will solve an important problem for people in this group by developing a liquid formulation of baclofen, the first-line anti-spastic medication, which can be administered through feeding tubes. The generic status of most spasticity drugs has limited additional formulation research because large drug companies have little incentive to pursue the relatively small market. Commercialization of a liquid formulation of baclofen, however, will improve both the quality and the cost of drug delivery. Quality is increased by a more extensive knowledge base about the interactions between baclofen and commonly used enteral feeding tubes. Cost of drug delivery is reduced at several levels. Caregivers across the U.S. will save thousands of hours of drug preparation time, valued at more than $50 million per year. Phase I of this SBIR will complete prototype drug development to identify a commercially feasible formula for this small molecule drug. The investigational design, research methods and analyses follow FDA guidelines, and have been successfully used by other businesses to obtain FDA marketing approval and commercialize their products. Phase I will also establish the bioequivalence analysis protocol to be followed in Phase II, and perform an initial feeding tube compatibility study with lead prototype drug candidates. To lower costs, Phase V Pharmaceuticals is partnering with a well-established pharmaceutical development company that will provide specialized equipment and skills.