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|Flex Pharma Data Presented at AAN Platform Session|
Company Presents Human Proof-of-Concept for Treating and Preventing Muscle 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 that control muscle contraction. The treatment is designed to reduce the firing of the neurons by topically stimulating the transient receptor potential (TRP) ion channels located in the gastrointestinal tract. Physical properties of the TRP activators largely limit their action to sensory neurons in the mouth, esophagus and stomach, with minimal concentrations reaching the bloodstream and, consequently, fewer potential systemic side effects.
“Based upon the novel insight that topical neurostimulation via oral
small molecules can act rapidly on the nervous system, we are excited
that these results show that the Flex proprietary treatment is effective
in reducing muscle cramping,” said
The studies evaluating this treatment consisted of three randomized, blinded, placebo-controlled crossover designs in a total of 37 healthy volunteers. The primary endpoint of each study was to evaluate the efficacy of the treatment in preventing muscle cramps. Each of the studies showed statistically significant results, demonstrating that Flex Pharma’s treatment reduced electrically induced muscle cramps within 15 minutes, and its effect lasted between six and eight hours compared to subjects taking a vehicle control. When data from the three studies were aggregated, the treatment showed a statistically significant overall treatment effect, reducing cramp intensity by three-fold compared to subjects taking a vehicle control (ANOVA, p<0.0001).
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This press release contains forward-looking statements for purposes of
the safe harbor provisions of the Private Securities Litigation Reform
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“believes,” “potential,” “proposed,” “continue,” “estimates,”
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“will,” “should” or other words that convey uncertainty of future events
or outcomes to identify these forward-looking statements.
Forward-looking statements include statements regarding our intentions,
beliefs, projections, outlook, analyses or current expectations
concerning, among other things: the success and timing of ongoing and
anticipated clinical studies for our current product candidates; and the
timing of and our expectations for the launch of our consumer product.
Various factors may cause differences between our expectations and
actual results as discussed in greater detail under the heading “Risk
Factors” in our Annual Report on Form 10-K for the year ended
Flex Pharma, Inc.