Flex Pharma, a biotechnology company, announced that it has initiated a human efficacy study that aims to help patients suffering from frequent nocturnal leg cramps. They used an oral tablet with a single molecule target called the transient receptor potential or TRP ion channel activator. The company reported that they will be having more than 50 subjects who were reported to be suffering from nocturnal leg cramps.
The Flex Pharma is known for developing treatments for cramps, spasms and nocturnal leg cramps. They also develop drugs that targets conditions such as MS and ALS and other exercise-associated cramps.
New Developments on the Treatment of Nocturnal Leg Cramps
A patient having nocturnal leg cramps feels severe pain that causes sleep interruption at night. Nocturnal Leg Cramps causes interference with the patient’s daily activities. It is estimated that around four million Americans suffer NLC. As of this time, there is no available therapeutic drug that can treat such condition.
According to Dr. Thomas Wessel, the Chief Medical Officer of Flex Pharma, their initial clinical findings had statistically significant results. He shared that they are now moving on to the Phase 2 of the study. Dr. Wessel is the lead medical officer who is responsible for the approval of three FDA approved drugs in the US namely Ampyra, Lunesta, and Razadyne.
Ampyra is used for patients having MS who are having difficulty in walking. While, Lunesta is a sedative hypnotic drug used for the treatment of sleep disorders. Razadyne is used for mild to moderate dementia.
John Windelman, MD., the Chief Officer of the Sleep Disorders Clinical Research Program at the Massachusetts General Hospital and also the Scientific Advisory Board Member of Flex Pharma noted that Flex Pharma is the forerunner in the development of the potential drug for the treatment of NLC. The clinical findings of the initial NLC study show encouraging results.
Windelman is very optimistic and hopeful with the final result of this study. He believes that if the drug yields significant findings, it will serve millions of people who are suffering from this painful condition. If this drug is approved, this will be the first ever drug that will be released in the market.
Dr. Bruce Bean, Co-founder and Scientific Advisory Board Co-chair and Harvard Medical School Professor of Neurophysiology, pointed out that this study will support the role of Chemical Neuro Stimulation as a strategy to reduce the hyperexcitability of alpha-motor neurons. This may potentially target other neuromuscular conditions that are associated with cramps like spasms and possibly spasticity.
Cramps No More…Fingers Crossed
It is alarming to note that there are millions of people who are suffering from Nocturnal Leg Cramps. If Flex Pharma will be successful in their clinical trials, a lot of people will take benefit from this drug. This is indeed a promising drug taking into account that it will be the first in the market.
Although, there are still more phases to complete before the drug reaches its target market, the medical community is hopeful that the results will be favorable.