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|Flex Pharma Announces Reduction of Muscle Cramping in Athletes|
-- Significant Effect in Preventing Exercise-Associated Muscle Cramps --
“We believe this is the first time any consumer beverage has shown a
statistically significant reduction of naturally occurring muscle cramps
in athletes,” said
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.
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.
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
Flex Pharma, Inc.