Bedtime Fibromyalgia Therapy TNX-102 SL Sees Faster-than-expected Trial Enrollment

Bedtime Fibromyalgia Therapy TNX-102 SL Sees Faster-than-expected Trial Enrollment

Enrollment in the RELIEF Phase 3 trial assessing TNX-102 SL (sublingual cyclobenzaprine) as a nighttime treatment for pain and disturbed sleep due to fibromyalgia has been faster than expected, according to Tonix Pharmaceuticals, therapy’s developer.

The company now anticipates enrollment completion from July to September, and top-line results later this year instead of next year.

The trial (NCT04172831) is seeking to recruit 470 adults with fibromyalgia, ages 18-65, across several U.S. sites. More information on contacts and locations is available here.

“We are pleased to announce that we will achieve our recruitment goal ahead of schedule,” Seth Lederman, MD, CEO of Tonix, said in a press release. “We have worked diligently to ensure the safe and timely recruitment of the RELIEF trial before and during the COVID-19 pandemic.”

TNX-102 SL is a reformulation of cyclobenzaprine, a muscle relaxant with the potential to reduce pain and stress as well as improve sleep. However, current oral formulations of cyclobenzaprine can only be used for short periods due to liver toxicity. 

“Fibromyalgia affects millions of adults globally and we believe that TNX-102 SL has the potential to offer a new, non-addictive treatment option for patients seeking relief from this disorder,” Lederman said. 

The potential non-opioid therapy is taken via sublingual, or under-the-tongue tablets, which Tonix says helps the active ingredient reach the bloodstream and limits liver damage. Tonix says this formulation suggests the therapy’s use for extended periods. 

TNX-102 SL was previously tested in the Phase 3 AFFIRM trial (NCT02436096). In AFFIRM, 519 patients with fibromyalgia were randomly assigned to receive either a 2.8 mg dose of TNX-102 SL or a placebo, taken daily at bedtime for 12 weeks.

The results showed that, while TNX-102 SL did not reduce the participants’ pain levels, it significantly improved sleep quality and reduced fatigue, compared with a placebo.

Based on these findings, Tonix launched the RELIEF Phase 3 trial to evaluate TNX-102 SL at a higher dose.

The study’s participants will start on a daily dose of 2.8 mg (one tablet) or a placebo, taken at bedtime for the first two weeks. Then, they will receive a higher dose of 5.6 mg (2.8 mg twice) or two placebo tablets for the next 12 weeks. 

Daily pain severity scores will be recorded by participants in a diary, and weekly averages of those daily scores will be reported. RELIEF’s primary goal is to assess changes in pain from the beginning of the study, or baseline, to week 14. Secondary measures include changes in functional ability and the overall impact of the disease. 

After the first 50% of participants complete treatment, an Independent Data Monitoring Committee (IDMC) will conduct a preliminary analysis of the findings. Those results are expected in September.