Flex Pharma Inc, a biotechnology company that is developing treatments for exercise-associated muscle cramps, nocturnal leg cramps, and spasms associated with severe neuromuscular conditions, 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 US 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,” says John Winkelman, MD, PhD, 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 [United States] 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,” says Flex Pharma chief medical officer Thomas Wessel, MD, PhD, 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.”