The company announced that its Phase 3 RELIEF Study will evaluate its TNX-102- SL in patients with fibromyalgia.
Tonix Pharmaceuticals Holding (NASDAQ:TNXP) has announced it has begun its Phase 3 RELIEF Study of TNX-102 SL for fibromyalgia.
As quoted in the press release:
“We are in the process of activating approximately 40 U.S. sites to start enrolling patients, and we expect to dose the first patient by year end 2019,” said Seth Lederman, M.D., President and Chief Executive Officer. “Initiating a new Phase 3 trial for TNX-102 SL in fibromyalgia is an important milestone for Tonix, physicians, and most importantly for the estimated 9 million U.S. adults suffering from this chronic, frequently debilitating central pain condition. Dr. Lederman continued, “Approximately one-third of those diagnosed with fibromyalgia in the U.S. are reported to receive chronic prescription opiates, which is part of the opiate crisis, since opiates are not believed to be effective for central pain. TNX-102 SL is a potential new, non-opioid, non-addictive analgesic that has been shown to have activity at a syndromal level, improving a broad array of fibromyalgia symptoms in prior Phase 2 and Phase 3 studies at the 2.8 mg dose.”
In a March 2019 Clinical Guidance meeting with the U.S. Food and Drug Administration (FDA), Tonix received guidance from the FDA to advance the development of TNX-102 SL 5.6 mg for the management of fibromyalgia. The Phase 3 study design features were discussed and agreed upon to test the safety and efficacy of TNX-102 SL at a dosage of 5.6 mg in a pivotal study to support the fibromyalgia indication with targeted enrollment of approximately 470 patients.
A lower dose of TNX-102 SL (2.8 mg) taken daily at bedtime was studied previously in fibromyalgia in a Phase 2 study and a Phase 3 study. In both studies, the 2.8 mg dose missed the primary endpoint of reduction in daily pain at Week 12. However, both studies showed broad clinical activity, evidenced by reduction of daily pain by other standard analytic approaches (30% responder analysis and mean pain, respectively) and improvements on the Fibromyalgia Impact Questionnaire – Revised, Patient Global Impression of Change, and measures of sleep quality. In Tonix’s posttraumatic stress disorder (PTSD) program, TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) demonstrated acceptable tolerability in PTSD patients. Furthermore TNX-102 SL 5.6 mg showed activity in reducing pain in PTSD patients with baseline chronic pain. In the clinical studies of TNX-102 SL in both the PTSD and fibromyalgia program, there were no serious and unexpected adverse events reported at the 2.8 mg or 5.6 mg doses; the most common adverse events were primarily related to local administration site reactions, such as transient oral hypoaesthesia (numbness) or paresthesia (tingling) or abnormal product taste after dosing.