Tonix to discontinue development of TNX-102 SL for fibromyalgia

The company said it will continue developing the drug for posttraumatic stress disorder (PTSD).

The preliminary topline results revealed that TNX-102 SL, taken once-daily at a 2.8-mg dosage, missed its primary efficacy endpoint in the Affirm phase 3 trial.

The drug did not achieve a statistically significant proportion of patients reporting a 30% or greater reduction in pain from baseline to the end of the trial’s 12-week treatment period.

It, however, showed statistically significant effects on pain at two additional endpoints, patient global impression of change and fibromyalgia impact questionnaire-revised during the trial.

The 12-week, randomized, double blind, placebo controlled trial was undertaken in 519 patients at 35 centers in the US who were given either 2.8 mg TNX-102 SL or placebo at bedtime in a 1:1 randomization.

Tonix president and CEO Seth Lederman said: "TNX-102 SL showed broad beneficial effects across key fibromyalgia symptoms and was well-tolerated in the Affirm study.

“Despite achieving clinically meaningful results from Affirm, we have greater clarity on the regulatory path forward in our PTSD program. We will therefore discontinue the fibromyalgia program in order to fully focus Tonix’s resources on advancing our potential breakthrough PTSD program to Phase 3.”

TNX-102 SL, which has not been approved for any indication, is designed to offer cyclobenzaprine to the bloodstream quickly through sublingual (under the tongue) absorption and to bypass first-pass hepatic metabolism.