Flex Pharma provides update on candidate for nocturnal leg cramp
Flex Pharma provided a nocturnal leg cramp regulatory and clinical update for FLX-787, a topically-acting, selective transient receptor potential ion channel agonist, which the company is evaluating for the treatment of nocturnal leg cramps, multiple sclerosis, amyotrophic lateral sclerosis and other disorders. FDA indicated that cramp frequency "could be an acceptable primary efficacy endpoint." While statistically significant results were seen in some, but not all, of the crossover endpoints, FLX-787 has shown positive signals on muscle cramping in the parallel design portion of two exploratory human proof-of-concept NLC studies. Data from these exploratory studies warrant further evaluation and development of FLX-787 in subjects with NLC. The company is planning a parallel design Phase 2 study in NLC to be initiated in 1H17, after the IND application has been submitted and accepted.