Tonix's sublingual formulation for fibromyalgia reaches pivotal trial stage

Tonix Pharmaceuticals ($TNXP) has completed enrollment in the 200-patient, placebo-controlled BESTFIT trial of sublingually delivered cyclobenzaprine for the treatment of fibromyalgia.

Sublingual delivery is superior to oral ingestion because it moves cyclobenzaprine into the bloodstream faster and increases the absorption rate by a factor of ten, Tonix CEO Dr. Seth Lederman said. He said the candidate, dubbed TNX-102SL, is designed for bedtime use, compared to oral cyclobenzaprine, which should be taken two hours before bedtime.

The clinical trial's primary endpoint is the mean change in week 12 average daily pain intensity measure on 11-point numeric rating scale. Secondary endpoints in the 12-week trial include a Fibromyalgia impact questionnaire and the patient's global impression of change, according to clinicaltrials.gov. In addition to body pain, other symptoms include sleep disturbance, fatigue and cognitive dysfunction.

Lederman expects FDA approval in 2017 followed by commercialization in 2018. The candidate is not a sleeping pill, he said, stressing it aims to improve sleep quality, not quantity.

"We are hoping that patients will feel better than they would have if they would have if they had taken an oral tablet at bedtime," Lederman said. Taking oral cyclobenzaprine at bedtime can result in a "hangover," he said, explaining that a sublingually delivered version would improve patient compliance and be more convenient.

Generic oral cyclobenzaprine medications like Teva's ($TEVA) Amrix for muscle spasms are commonly prescribed off-label for fibromyalgia, Lederman said. He said the candidate will be for chronic use, but Teva warns against taking Amrix for more than three weeks, citing a lack of evidence for effectiveness over long periods of time for the treatment of muscle spasms.

To that end, patients who complete the BESTFIT trial will be invited to participate in an ongoing 52-week safety extension trial, Lederman said, and added that if the 12-week pivotal trial of efficacy is successful, Tonix will follow it up with a second pivotal trial to meet FDA requirements. According to clinicaltrials.gov, Tonix is already running four trials on the candidate's safety and bioavailability.

Tonix says fibromyalgia affects about 5 million adults in the U.S. Later this year the company plans to begin clinical development of the candidate for post-traumatic stress disorder.

- read the release

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