Date: 2014-09-29
Type of information: Results
phase: 1
Announcement: results
Company: Flamel Technologies (France)
Product: LiquiTime® Ibuprofen
Action mechanism:
Disease:
Therapeutic area: CNS diseases
Country:
Trial details:
Latest
news: * On September 29, 2014, Flamel Technologies announced the results of a First-in-Man clinical study in healthy volunteers using its proprietary LiquiTime® drug delivery platform applied to ibuprofen, a broadly used medication for pain. LiquiTime is designed to provide a controlled, extended release of oral liquids principally for pediatric and geriatric patients. The trial was designed as a 15-subject three-way crossover in healthy volunteers evaluating two different BID (twice daily) formulations of LiquiTime ibuprofen with an immediate release ibuprofen oral suspension as the control arm. One formulation of LiquiTime ibuprofen was shown to be bioequivalent to the immediate release ibuprofen oral suspension using the FDA requirements for bioequivalence. There were no safety or tolerability issues. LiquiTime is protected by the Company\'s intellectual property through late 2025 in the United States and through early 2023 in Europe. This study is the first of two planned programs in Flamel\'s pipeline of proprietary products using the Company\'s LiquiTime technology for the Over-The-Counter or OTC market. \"The next step will be to move this product into a pivotal bioequivalence study in 2015,\" said Mike Anderson, Chief Executive Officer of Flamel.
