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Flex Pharma (NASDAQ: FLKS) announced its proprietary treatment prevented muscle cramps in an initial study of athletes participating in high intensity sports.
“We believe this is the first time any consumer beverage has shown a statistically significant reduction of naturally occurring muscle cramps in athletes,” said Marina Hahn, Flex Pharma’s President of Consumer. “As we prepare to launch our product in the first half of 2016, it is critical to test our product in real-life athletic scenarios.”
The study evaluated Flex Pharma’s proprietary treatment in a total of 23 healthy athletes who frequently suffer from muscle cramps while engaging in high intensity sports. Participants included men and women that train 3-4 times a week. Participants administered the treatment 15-30 minutes prior to exercise. The study was intended to evaluate the efficacy of the proprietary treatment in preventing muscle cramps as measured by the incidence of cramps during training sessions. The study showed statistically significant results (p<0.01 by Poisson regression), demonstrating that Flex Pharma’s treatment reduced muscle cramps during a two week workout period by more than 50% when compared to the prior two week baseline observation period. The study also demonstrated a trend towards a reduction in cramp duration.
In another arm of the study, 21 healthy athletes administered the proprietary product as an acute treatment, administered at the onset of a muscle cramp. These data showed positive trends with approximately two-thirds of athletes claiming relief within five minutes when the proprietary treatment was taken at the onset of a muscle cramp.
“This is the first study to demonstrate that our proprietary treatment prevents cramps occurring in a natural setting and adds to the growing body of data that TRP activators may be an effective new treatment in individuals suffering from cramps and spasms,” noted Dr. Tom Wessel, Flex Pharma Chief Medical Officer. “Based upon the consistent outcomes in this initial study, we are now planning larger, placebo-controlled studies in athletes to further support these results.”
The Company expects to present these study results at a future medical meeting. These exercise-associated muscle cramp results follow three randomized, blinded clinical studies, previously reported, where treatment was shown to prevent cramps in electrically induced human cramps.
Flex Pharma’s proprietary treatment is based on research showing that cramps are caused by excessive firing of alpha-motor neurons in the spinal cord. These nerve cells connect to muscle cells through axons and control muscle contraction. The treatment effect occurs quickly by topical neurostimulation of transient receptor potential (TRP) ion channels on sensory fibers in the mucous membranes of the mouth, throat, esophagus and stomach, with minimal concentrations reaching the bloodstream and, consequently, fewer potential systemic side effects.
Source: Street Insider