Tonix signs on Rho to support NDA submission for fibromyalgia drug

Tonix Pharmaceuticals has tapped CRO Rho to support the New Jersey-based biotech’s plans to submit a new drug application (NDA) for its drug designed to manage fibromyalgia.

The deal follows the December release of phase 3 study results assessing Tonmya, a sublingual tablet formulation of cyclobenzaprine hydrochloride. In the study, the drug reduced daily pain compared to placebo in participants with fibromyalgia, a result that was statistically significant.  

Financial terms of the new agreement weren’t disclosed.

“We intend to meet with the FDA in the first half of this year and to submit our NDA in the second half of the year,” Tonix CEO Seth Lederman, M.D., said in the release. “We believe we have completed all development work required for the NDA, including CMC requirements and the completion of two positive phase 3 studies.”

Tonix had hoped its investigations into cyclobenzaprine for fibromyalgia-like long COVID would succeed. However, the company abandoned that indication last September after it failed to show a statistically significant improvement in pain symptoms compared to placebo in a phase 2 trial of patients with long COVID.

In November, Tonix's pipeline took another hit as the biotech dropped a major depression disorder therapy due to a phase 2 flop. The biotech is now focusing resources on central nervous system R&D.