Date: 2015-03-27
Type of information: Results
phase: 1
Announcement: results
Company: Flamel Technologies (France)
Product: LiquiTime® Guaifenesin
Action
mechanism: Guaifenesin is an expecorant drug.
Disease:
Therapeutic area:
Country:
Trial details:
Latest
news: * On March 27, 2015, Flamel Technologies announced the results of a First-in-Man clinical study in healthy volunteers using its proprietary LiquiTime® drug delivery platform applied to guaifenesin, a broadly used expectorant. LiquiTime is designed to provide a controlled, extended release of oral liquids principally for pediatric and geriatric patients.
The Company conducted a 16-subject four-way crossover pharmacokinetic study in healthy volunteers evaluating three different BID (twice-daily) formulations of LiquiTime guaifenesin against immediate release guaifenesin tablets dosed every 4 hours. The trial was intended to provide sufficient data for the Company to choose the best prototype to move forward into a pivotal study. While none of the prototype formulations in this relatively small pilot study exactly satisfied all of the criteria necessary for proving bioequivalence of AUC (Area Under the Curve) to the immediate release guaifenesin tablets under FDA's requirements, the results clearly met the intention of the study. The chosen formulation will be optimized and scaled up over the coming months and Flamel plans to perform a pivotal study in 2016. There were no safety issues raised during the study. LiquiTime is protected by the Company's intellectual property through late 2025 in the United States and through early 2023 in Europe.
