LYON, France--(BUSINESS WIRE)--Flamel Technologies (NASDAQ:FLML) today announced positive preliminary Phase I data from a trial comparing the safety, tolerability, and long-acting activity of FT-105 versus Lantus®, an approved basal insulin. FT-105 is a long-acting recombinant insulin formulation that uses a new microparticulate adaptation of Flamel’s proprietary Medusa® nanoparticle delivery system. Results from the trial showed that FT-105 achieved a sustained release of recombinant human insulin over the course of the 36-hour pharmacodynamic study period. Pharmacokinetic results indicate that insulin concentrations were sustained for more than 48 hours in subjects following a single dose of FT-105. Less diurnal variation in insulin concentration was observed in subjects administered FT-105 compared with Lantus. FT-105 was well tolerated by subjects, especially with respect to local tolerance. No serious adverse events were reported and no patients withdrew from the study due to adverse events. Flamel is seeking a licensing partner for this product.
