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Flex Pharma Collaborator Penn State Presents Positive Human Muscle Cramp Data

-- Presentation at Experimental Biology 2016 Conference Shows Positive Effect on Athletic Human Muscle Cramps --

BOSTON--(BUSINESS WIRE)--Apr. 6, 2016-- Click to Tweet

Flex Pharma, Inc. (NASDAQ: FLKS) announced today that results from a study showing that its proprietary formulation of TRPA1 and TRPV1 activators prevented volitional muscle cramps will be presented today at the Experimental Biology conference. In the study, run by leading academics at The Pennsylvania State University (PSU), the Company’s proprietary formulation showed a statistically significant benefit in reducing muscle cramps in athletes as compared to vehicle control (as measured by the intensity-duration profile of voluntarily induced muscle cramps). Additionally, subject ratings of muscle soreness resulting from cramps were also lower compared to vehicle control. Flex Pharma is a biotechnology company developing innovative and proprietary treatments for exercise-associated muscle cramps, nocturnal leg cramps, and cramps and spasms associated with severe neuromuscular conditions.

“Muscle cramps interfere with athletic performance in many different sports. Our model of voluntarily initiated muscle cramps allows us to reliably trigger cramps and test various intervention strategies. The results we are presenting at Experimental Biology 2016 are striking in that they confirmed that oral TRP channel activators significantly reduced the intensity and duration profile of muscle cramps, consistent with results from studies that have evoked muscle cramps using electrical stimulation,” cited Dr. W. Larry Kenney, Professor of Physiology and Kinesiology at the Noll Laboratory at PSU. “As this volitional model more closely reproduces the effects of naturally occurring exercise-associated muscle cramps, I would expect these results to translate to the natural setting. I am not aware of any other consumer product that has demonstrated significant efficacy in mitigating muscle cramps in a rigorous double-blinded scientific study.”

To test this effect on voluntarily initiated calf muscle cramps, PSU researchers conducted a randomized, double-blinded, vehicle-controlled crossover study. Twenty subjects, males and females, ages 19-25 years, were able to consistently reproduce cramps voluntarily. Each of the 20 enrolled subjects was randomized, ingested either active or control, with cramp profiles measured by surface electromyography (EMG), and then subsequently crossed-over with a week between treatments.

“The research at the Noll Laboratory at PSU supports the development of our consumer product and complements our electrically-induced cramp model. These results confirm the utility of oral TRP channel activation as a rapid and effective method to prevent muscle cramps in athletes," commented Dr. Tom Wessel, Chief Medical Officer of Flex Pharma. “We believe that the benefits observed in athletes depend on the same underlying mechanisms in the central nervous system that reduce cramping in nocturnal leg cramps and potentially other conditions such as MS and ALS.”

About Flex Pharma

Flex Pharma, Inc. is a biotechnology company that is developing innovative and proprietary treatments for nocturnal leg cramps, cramps and spasms associated with severe neuromuscular conditions such as ALS and MS, and exercise-associated muscle cramps. Flex Pharma was founded by National Academy of Science 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 Chair and CEO Christoph Westphal, M.D., Ph.D.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “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: our expectations regarding future studies of our current product candidates; and our beliefs regarding the potential benefits of our current product candidates. 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 interpretations of our clinical studies; the uncertainties inherent in conducting clinical studies, including receiving regulatory approval to conduct these studies; the fact that we rely on third parties to manufacture and conduct the clinical studies of our product candidates, which could delay or limit future development or regulatory approval; results from ongoing and planned preclinical development; expectations of our ability to make regulatory filings and obtain and maintain regulatory approvals; our ability to develop and commercialize our consumer product; anticipated positioning and product attributes of our consumer product; results of early clinical studies as indicative of results of future trials; the inherent uncertainties associated with intellectual property; 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, 2015 and subsequent filings with the Securities and Exchange Commission (SEC). You are encouraged to read Flex Pharma’s 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.

Source: Flex Pharma, Inc.

Flex Pharma, Inc.
Elizabeth Woo, 617-874-1829
SVP, Investor Relations & Corporate Communications
irdept@flex-pharma.com