NEW YORK, Aug. 08, 2016 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), which is developing next-generation medicines for fibromyalgia and post-traumatic stress disorder (PTSD), announced financial results for the second quarter ended June 30, 2016.
“Our late-stage programs gained significant momentum in the second quarter. We completed enrollment in our flagship Phase 3 fibromyalgia trial, AFFIRM, for which we plan to report topline data in September. AFFIRM, which enrolled 519 fibromyalgia patients, is a randomized, double-blind placebo-controlled study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets), 2.8 mg, dosed at bedtime over twelve weeks. Also, during the second quarter, we reported positive results from our Phase 2 AtEase study of TNX-102 SL in military-related PTSD. The data support that TNX-102 SL, 5.6 mg, is an effective and well tolerated dose in this population. These findings support the advancement of TNX-102 SL, 5.6 mg, for PTSD Phase 3 development,” said Seth Lederman, M.D., president and chief executive officer of Tonix. “Our key focus for the third quarter is on our fibromyalgia program, highlighted by the upcoming announcement of topline data from our first Phase 3 AFFIRM study in September, and the ongoing enrollment in our recently initiated second Phase 3 RE-AFFIRM study.”
“Our late-stage programs gained significant momentum in the second quarter. We completed enrollment in our flagship Phase 3 fibromyalgia trial, AFFIRM, for which we plan to report topline data in September. AFFIRM, which enrolled 519 fibromyalgia patients, is a randomized, double-blind placebo-controlled study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets), 2.8 mg, dosed at bedtime over twelve weeks. Also, during the second quarter, we reported positive results from our Phase 2 AtEase study of TNX-102 SL in military-related PTSD. The data support that TNX-102 SL, 5.6 mg, is an effective and well tolerated dose in this population. These findings support the advancement of TNX-102 SL, 5.6 mg, for PTSD Phase 3 development,” said Seth Lederman, M.D., president and chief executive officer of Tonix. “Our key focus for the third quarter is on our fibromyalgia program, highlighted by the upcoming announcement of topline data from our first Phase 3 AFFIRM study in September, and the ongoing enrollment in our recently initiated second Phase 3 RE-AFFIRM study.”
