Flamel Reports Positive Results From First-in-Man Trial With LiquiTime Ibuprofen

(RTTNews) - Flamel Technologies (FLML) announced the results of a First-in-Man clinical study in healthy volunteers using its LiquiTime drug delivery platform applied to ibuprofen, a broadly used medication for pain. 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, the company said. There were no safety or tolerability issues.

"We are very pleased with this initial data on LiquiTime ibuprofen as it is the first of two planned programs in our 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, CEO of Flamel.