Tonix Pharma’s Expansion of TNX-102 SL Program to Include Fibromyalgia
A PPM Brief
Tonix Pharmaceuticals (New York, NY) expanded1 its TNX-102 SL 5.6 mg program beyond post-traumatic stress disorder (PTSD) to include Phase 3 development targeting the potential treatment of fibromyalgia. TNX-102 SL (brand name: Tonmya) is Tonix Pharma’s lead Phase 3 program in PTSD, with the RECOVERY trial actively enrolling military and civilian PTSD participants. In a recent meeting with the FDA, the company received guidance and support to advance TNX-102 SL, a non-opioid centrally acting analgesic, for the management of fibromyalgia, establishing the safety and efficacy in a pivotal study to support its indication, according to a company release.
A lower dose (2.8 mg) of TNX-102 SL, taken daily at bedtime, was studied previously in patients with fibromyalgia in a Phase 2 and Phase 3 study, both showing clinical benefit, especially in quality of sleep improvement (primary analyses on pain reduction were not statistically significant, however). There were no serious adverse events reported; the most common side effects were local administration site reactions, such as oral hypoesthesia and abnormal product taste.
“There is a pressing need for new drugs to treat patients with fibromyalgia, especially considering that approximately one-third of fibromyalgia patients are on chronic opiates,” said Seth Lederman, MD, Tonix Pharma's president and chief executive officer, in the press release.
The company reported that increasing the dose of TNX-102 SL from 2.8 mg to 5.6 mg in the new Phase 3 fibromyalgia study will likely be the efficacious dose for the management of fibromyalgia. Registration will be supported by two positive Phase 3 studies, and the long-term safety exposure data from the PTSD program may support the fibromyalgia new drug application (NDA).
“FDA’s acceptance of the well-established safety information of currently-marketed oral cyclobenzaprine products and their agreement that TNX-102 SL 5.6 mg long-term exposure data from our PTSD studies may support the fibromyalgia indication are very reassuring. We are looking forward to submitting a final Phase 3 protocol and statistical analysis plan for FDA acceptance prior to study initiation,” concluded Dr. Lederman.
