Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) presented a readout of the positive results from the Phase 3 Clinical trial, RELIEF study, of TNX-102 SL to manage fibromyalgia effectively.
The 2021 ACSP annual conference presentation is under the title – safety and efficacy of the Sublingual Cyclobenzaprine to treat fibromyalgia in the Phase 3 Relief study.
Accomplishes primary and secondary endpoints
According to the readout of the RELIEF study, the formulation achieved the prespecified primary objective of reducing the daily pain significantly compared to a placebo.
Promotes sleep quality and mitigates fatigue
5.6 mg of TNX-102 SL also achieved the secondary endpoint of reducing fatigue, improved sleep quality, specific functional recovery from fibromyalgia. The drug also demonstrated improved tolerance in the subjects in a double-blind, randomized, and placebo-controlled Phase 3 clinical trial. It did not show any side effects such as nausea, insomnia, sexual dysfunction, and weight gain usually observed in oral administration of other approved fibromyalgia treatments in the markets.
Seth Lederman, Tonix’s CEO, said phase 3 clinical study results validated the formula to improve sleep quality. It also helped the patients to manage fatigue, sleep, and daily pain associated with fibromyalgia.
Tonix will publish the confirmatory results of the Phase 3 RELIEF study of TNX-102 SL in Q3 2021. It expects to present the topline results of the trial in 2022.
What is fibromyalgia?
Chronic pain – fibromyalgia is caused by the pain and sensory signaling in the CNS (central nervous system). According to recent statistics, around 6 to 12 million adults in the US experience fibromyalgia.
Fibromyalgia affects more prevalent in females. Other fibromyalgia symptoms are mood disturbances and cognitive dysfunction such as depression and anxiety.
People with fibromyalgia struggle to manage their daily chores and could not enjoy a quality life. According to trends in the market, other available approved formulations are not up to the mark in helping the patients to manage daily pain and reduce fatigue.
Formulation and effectiveness of TNX-102 SL
The sublingual patented tablet – TNX-102 SL is derived from cyclobenzaprine hydrochloride. It promotes quick transmucosal absorption and mitigates the production of norcyclobenzaprine.
TNX-102 SL is recommended at bedtime to calm agitation related to Alzheimer’s disease, alcohol use disorder, PTSD, and fibromyalgia.