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Tonix hires Rho to support submission of fibromyalgia candidate for FDA review

Posted by on 20 February 2024
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Rho will support the submission of a candidate fibromyalgia treatment – called Tonmya - under a deal with developer, Tonix Pharmaceuticals.

Tonix plans to file the drug – a sublingual formulation of cyclobenzaprine HCl known as TNX-102 SL– with the US Food and Drug Administration (FDA) before the end of the year.

In December data from a Phase III trial – called Resilient – showed the drug brought about a significant reduction in pain in patients suffering fibromyalgia versus placebo. Statistically significant and clinically meaningful results were also seen in secondary endpoints related to sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function.

The study was referenced by Tonix CEO, Seth Lederman, who shared outlines of the firm’s submission plan in a statement.

“We are excited by our most recent positive Phase III study results of Tonmya and look forward to Rho’s support in preparing our NDA.

“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. We believe we have completed all development work required for the NDA, including CMC requirements and the completion of two positive Phase III studies.”

Rho President, Tara Gladwell, was also upbeat, adding “We are delighted in our continued support of Tonix and their Tonmya program.

“We are hopeful that this work may result in a new treatment for the millions of Americans that suffer from this debilitating, chronic disorder,” she continued.

In other news, Tonix announced the receipt of US FDA approval to evaluate TNX-102 SL1 in reducing the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD).

According to the firm, the trial will be sponsored by The University of North Carolina (UNC) Institute for Trauma Recovery and supported by a $3 million grant from the US Department of Defense (DoD).


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