Flex Pharma, Inc. (NASDAQ: FLKS), a biotechnology company that is developing innovative and proprietary treatments for exercise-associated muscle cramps, nocturnal leg cramps, and spasms associated with severe neuromuscular conditions, today 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.
About Flex Pharma
Flex Pharma, Inc. is a biotechnology company that is developing innovative and proprietary treatments for exercise-associated muscle cramps, nocturnal leg cramps, and spasms associated with severe neuromuscular conditions. In three randomized, blinded, placebo-controlled, cross-over studies, Flex Pharma's proprietary treatment has shown a statistically significant reduction in the intensity of muscle cramps in healthy normal volunteers.
Flex Pharma was founded by National Academy of Sciences members Rod MacKinnon, M.D. (2003 Nobel Laureate), and Bruce Bean, Ph.D., recognized leaders in the fields of ion channels and neurobiology, along with Chairman and Chief Executive Officer Christoph Westphal, M.D., Ph.D.
Follow Flex Pharma on twitter @flexphama and visit the Company’s web site (www.ItsTheNerve.com and www.flex-pharma.com) for updates of the Company’s pre-launch activities for its consumer product to prevent and treat exercise-associated muscle cramps.
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the design and timing of ongoing and anticipated studies and our plans to develop and commercialize our consumer products. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation: the status, timing, costs, results and interpretation of our clinical studies; the uncertainties inherent in conducting clinical studies; our ability to develop and commercialize our consumer products; anticipated positioning and product attributes of our consumer products; results of early clinical studies as indicative of the results of future trials; and other factors discussed in greater detail under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2014 and subsequent filings with the Securities and Exchange Commission (SEC). You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.