Flex Pharma initiates human efficacy study with single molecule tablet in nocturnal leg cramps

Single molecule TRP ion channel agonist in randomized, blinded, controlled, cross-over study.

Nocturnal leg cramps can cause severe pain, interrupted sleep, reduced quality of life and interference with activities of daily living. The company estimates that NLC affects over four million Americans nightly; there is no approved therapeutic in the US to treat this condition.

“Based upon the statistically significant positive results from our recently completed human efficacy study in NLC with our proprietary extract formulation, we moved rapidly to initiate this NLC study with our single molecule TRP activator and we expect to soon begin Phase II studies with this agent in MS and ALS,” said Flex Pharma Chief Medical Officer Thomas Wessel, who served as the medical lead for three products approved in US: Razadyne, Lunesta and Ampyra. The company's studies of this agent in MS and ALS will be conducted outside the US.

“Flex Pharma is at the forefront of clinical development in NLC and the statistically significant human efficacy data generated in the prior NLC study are highly encouraging,” noted John Winkelman, Chief of the Sleep Disorders Clinical Research Program at Massachusetts General Hospital and Flex Pharma Scientific Advisory Board member. “I am hopeful that Flex Pharma’s efforts will ultimately help the millions of people who suffer from this painful condition and currently have no safe and effective therapeutic options.”

“The recently completed study results support using the approach of specific TRP ion channel activation to reduce nocturnal leg cramps via Chemical Neuro Stimulation,” stated Bruce Bean, Harvard Medical School Professor of Neurophysiology and Flex Pharma Co-founder and Scientific Advisory Board Co-Chair. “These upcoming studies in multiple indications may help confirm the role of Chemical Neuro Stimulation as the general strategy to reduce alpha-motor neuron hyperexcitability for a broad range of neuromuscular conditions associated with cramps, spasms and possibly spasticity.”