Phase 2 Trial of FLX-787 has stopped, but there is still hope for those suffering from muscle cramps!
About a year ago, the U.S. Food and Drug Administration granted fast track status to Flex Pharma’s treatment for severe muscle cramps in ALS, FLX-787. Flex Pharma has just announced the cease of research and clinical trials of FLX-787.
The Phase 2 trial in the US was evaluating the effectiveness of FLX-787 administered at 30mg three times a day in comparison to placebo. The desired result is an overall reduction in muscle cramps.
Although there were some promising results, there were tolerability issues with the formulation and dosage. Now Flex Pharma is restructuring to lower costs and cutting its workforce by nearly 60 percent. The future is on hold and uncertain with FLX-787.
Other solutions exist. There is still hope to diminish or eliminate some of the musculature symptoms that accompany ALS. The Deanna Protocol by Dr. Vincent Tedone has demonstrated numerous cases of anecdotal evidence that decreases the overall symptoms of spasticity and fasciculation. Not only does it help motor neurons function properly, but has shown promising results in helping the body delay the advancement of the disease by reducing cell death.
In addition, existing ALS clients adhering to the Deanna Protocol, as formulated by Simplesa Nutrition, have reported very good tolerability of the supplements with little to no discomfort or side effects. It would seem that the strategy to help your body heal itself (or at least help it fight a better fight) by providing it with the necessary nutritional supplements is still a worthwhile option.
The moral of the story is to stay in the fight and seek alternative treatments. There are existing and continuously evolving solutions out there to help improve the quality of life of those suffering from ALS and other neurodegenerative diseases.
1. ALS News Today: Flex Pharma Stops Phase 2 Trial of FLX-787 to Ease Muscle Cramps in ALS Patients. June 15, 2018 by Jose Marques Lopes, PHD
2. ALS News Today: FLX-787, Which Treats ALS-Associated Muscle Cramps, Wins FDA Fast Track Status. July 26, 2017 by Carolina Henriques
3. Tedone M.D., V.M., Tedone-Gage, D., & Tedone, C. The Deanna Protocol Hope for ALS and Other Neurological Conditions. Tampa: Paradies/ Inspire, LLC, 2015. Print.