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Tonix Pharma’s Expansion of TNX-102 SL Program to Include Fibromyalgia

A higher dose may be efficient to treat patients in this population

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.

(Source: 123RF)

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.

Last updated on: April 18, 2019
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