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Flex Pharma Initiates Human Proof-of-Concept Efficacy Study in Nocturnal Leg CrampsFlex 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 that it has initiated a human proof-of-concept efficacy study in nocturnal leg cramps (NLC) with its proprietary treatment. Nocturnal leg cramps can cause severe pain, interrupted sleep, reduced quality of life and interference with activities of daily living. The randomized, blinded, placebo-controlled, cross-over study is expected to enroll approximately 40 subjects who experience NLC at least four nights per week. "An estimated four million U.S. adults over the age of 65 suffer daily from nocturnal leg cramps, a condition for which there is significant unmet need since there are no effective treatments," stated John Winkelman, M.D., Ph.D., Chief of the Sleep Disorders Clinical Research Program at Massachusetts General Hospital and member of the Flex Pharma Scientific Advisory Board. "With the aging population demographics in the U.S. and the known assocation of NLC with age, the number of people suffering regularly from NLC is expected to increase considerably over the next decades." "Flex Pharma is at the forefront of clinical development in NLC," said Flex Pharma Chief Medical Officer Thomas Wessel, M.D., Ph.D., who served as the medical lead for three products approved in United States: Razadyne®, Lunesta® and Ampyra®. "As a neurologist, I've seen first hand how much need there is for a therapeutic option to treat NLC and I hope our efforts will ultimately help the millions of those who suffer from this painful condition." 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 (News - Alert) 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. 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: the success and timing of ongoing and anticipated clinical studies for our current product candidates; and expectations regarding the number of individuals that may suffer from nocturnal leg cramps. 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 December 31, 2014 and subsequent filings with the Securities and Exchange Commission (SEC (News - Alert)). 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. |
