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Flex Pharma’s Positive Human NLC Study Selected for Presentation at AAN Annual Meeting

Flex Pharma, Inc. FLKS, -1.01% announced that results from its recently completed study in nocturnal leg cramps (NLC) will be presented later today at the American Academy of Neurology (AAN) 68 [th] Annual Meeting in Vancouver, B.C., Canada. As one of only 14 abstracts selected for late-breaking presentations at the AAN annual meeting, the abstract titled, “Orally-administered TRPV1 and TRPA1 activators reduce Nocturnal Leg Cramps in a randomized, blinded, placebo-controlled, crossover human trial,” will be presented during the Emerging Science Session at 6:21p.m PDT, followed by a poster presentation from 6:30-7:15pm PDT. Flex Pharma is a biotechnology company developing innovative and proprietary treatments for NLC, cramps and spasms associated with severe neuromuscular conditions such as MS and ALS, and exercise-associated muscle cramps.

The Company estimates that NLC affects four million Americans nightly; there is no approved therapeutic in the United States to treat this condition. The randomized, blinded, controlled, crossover study evaluated 50 healthy subjects (50-77 years of age) who experienced Nocturnal Leg Cramps at least four nights per week. After an initial placebo run-in period to remove placebo responders, subjects were randomized to either control or study product (extract formulation) for two weeks. Subjects were then crossed over to the other treatment for another two-week period so that each subject acted as his or her own control.

The extract formulation resulted in a median reduction of 6 total cramps over a 2-week period vs. 4 for placebo (p<0.05) and median increase of 2 total cramp-free nights vs. 1 for placebo (p<0.01). The positive effects were seen across a broad range of enrolled subjects; in addition, a subset of patients showed pronounced benefit. The magnitude of efficacy in this study on reduction in muscle cramps appears similar to published “Class 1 level” quinine efficacy studies. “Class 1 level” efficacy studies are randomized, controlled clinical trials of the intervention with masked or objective outcome assessment, in a representative population.

Quinine, the only therapeutic intervention for leg cramps with randomized, controlled, blinded study support for efficacy, is also associated with serious adverse events and was banned for the treatment of leg cramps by the FDA. In the U.K. where quinine is still available and the population is approximately one-fifth the...


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