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Flex
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 association 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 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.
Copyright Business Wire 2015