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Enrollment Completed in Flex Pharma’s Exploratory Human Nocturnal Leg Cramp Study

-- Company Expects to Report Results Q1 2016 --

BOSTON--(BUSINESS WIRE)--Jan. 6, 2016-- Flex Pharma, Inc. (NASDAQ: FLKS):

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Flex Pharma, Inc. (NASDAQ: FLKS), a biotechnology company developing innovative and proprietary treatments for spasms associated with severe neuromuscular conditions, nocturnal leg cramps and exercise-associated muscle cramps, announced today that enrollment has been completed in its exploratory human efficacy study in nocturnal leg cramps (NLC) with its original proprietary extract formulation. NLC can cause severe pain, interrupted sleep, reduced quality of life and interference with activities of daily living. The randomized, blinded, controlled, crossover study enrolled over 40 subjects who experience NLC at least four nights per week. This study is intended to assess the safety and tolerability of the proprietary treatment and explore a number of alternative objectives relating to efficacy. The Company expects to report results from this study during the first quarter of 2016.

“Flex Pharma is developing treatments based on Chemical Neuro Stimulation, the process by which a small molecule, acting topically, is translated into an electrical signal for therapeutic effect,” said Dr. Rod MacKinnon, Nobel laureate and Flex Pharma Scientific Co-Founder, Board Member, and Scientific Advisory Board Co-Chair.

“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 the need for a therapeutic option to treat NLC. I hope our efforts will ultimately help the millions of those who suffer from this painful and debilitating condition, for which there are currently no approved drug products in the U.S.”

The Company estimates four million U.S. adults over the age of 65 suffer daily from nocturnal leg cramps. With the aging population demographics in the U.S. and the known association of NLC with age, the number of people suffering regularly from NLC is expected to increase considerably over the next decades.

About Flex Pharma

Flex Pharma, Inc. is a biotechnology company that is developing innovative and proprietary treatments for spasms associated with severe neuromuscular conditions, nocturnal leg cramps and exercise-associated muscle cramps. 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.

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). 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