Tonix Pharma plunges on failure of fibromyalgia drug in Phase III

Shares of Tonix Pharmaceuticals (Nasdaq: TNXP) plunged nearly 50% to $1.10 in premarket trading on Tuesday, when the company announced preliminary top-line AFFIRM Phase III trial results, showing that its TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in patients with fibromyalgia has failed to achieve its goals.

AFFIRM was a 12-week randomized, double-blind, placebo-controlled trial of TNX-102 SL taken daily at bedtime, in which 519 participants were enrolled at 35 centers in the USA. Fibromyalgia is a multi-symptom disorder that originates in the central nervous system and is characterized by widespread pain, non-restorative sleep, fatigue and disability.

The AFFIRM data did not achieve statistical significance in the primary efficacy endpoint: the proportion of patients who reported a 30% or greater reduction in pain from baseline to the end of the 12-week treatment period based on the pre-specified primary analysis (p=0.095, Table 1).