Enrollment is complete in Flex Pharma Inc’s exploratory human efficacy study in nocturnal leg cramps (NLC) with Flex Pharma’s original proprietary extract formulation. Flex Pharma is a biotechnology company developing treatments for spasms associated with severe neuromuscular conditions, nocturnal leg cramps, and exercise-associated muscle cramps.

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,” says Rod MacKinnon, MD, Nobel laureate and Flex Pharma Scientific co-founder, board member, and scientific advisory board co-chair, in a release.

Flex Pharma chief medical officer Thomas Wessel, MD, PhD, says, “Flex Pharma is at the forefront of clinical development in NLC. 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 US”

The company estimates four million US adults over the age of 65 suffer daily from nocturnal leg cramps. 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.