TONIX Pharmaceuticals, Inc.'s Pain Drug Fails Phase 2b Study
September 29, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Today, Tonix Pharmaceuticals Holding Corporation released the results of its Phase 2b Bedtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy study, also known as BESTFIT. This study looked at TNX-102 SL as a chronic bedtime treatment for fibromyalgia.
The study did not achieve statistical significance in terms of its primary efficacy endpoint, which was a change in average daily pain score at Week 12. However, the study showed that TNX-102 SL had an effect on pain by a 30 percent responder analysis of the primary pain data. The Phase 2b study also showed improvements with the drug in key secondary analyses of the Patient Global Impression of Change and Fibromyalgia Impact Questionnaire-Revised total score.
"TNX-102 SL showed broad activity across key fibromyalgia symptoms in the BESTFIT study, and the treatment was well tolerated,” said Seth Lederman, president and chief executive officer of Tonix. “While the study did not achieve statistical significance on the primary endpoint, this is a very supportive study for the Phase 3 clinical program. Also, these findings validate our approach to develop a differentiated drug that acts beyond analgesia to improve multiple symptom domains of a complex condition. The activity of TNX-102 SL was cross-validated by two endpoints, FIQ-R and PGIC, which assess a range of fibromyalgia symptoms and global improvement.”
BESTFIT also showed that there was a significant improvement on measures of sleep quality with the drug, and there were improvements on several FIQ-R items such as anxiety, stiffness, sleep quality, pain and sensitivity. "We plan to meet with the Food and Drug Administration to review the BESTFIT data and to design an acceptable Phase 3 program." Lederman continued. "These results also support the potential clinical benefit of TNX-102 SL for the treatment of post-traumatic stress disorder. We are confident that addressing disturbed sleep will provide a new treatment option for those suffering with PTSD and the BESTFIT data show that TNX-102 SL has strong positive effects on sleep quality."
BESTFIT was a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of TNX-102 SL, also known as cyclobenzaprine HCl 2.8 mg sublingual tablets. There were 205 participants in the study enrolled at 17 centers across the U.S. A total of 204 people received at least one dose of the medication.