Enrollment Open in Second Phase 3 Trial of Higher TNX-102 SL Dose for Managing FM

Enrollment Open in Second Phase 3 Trial of Higher TNX-102 SL Dose for Managing FM
The second Phase 3 clinical trial examining a higher dose of TNX-102 SL (sublingual cyclobenzaprine), Tonix Pharmaceuticals' bedtime treatment for managing fibromyalgia, is enrolling participants. The RALLY trial (NCT04508621) is recruiting 470 adults with fibromyalgia, ages 18–65. Nearly 40 U.S. sites are enrolling, or will be. More information about contacts and locations is available here. Tonix expects to report top-line data from this trial in the second half of 2021. Meanwhile, early results are expected this month for the RELIEF trial (NCT04172831), the first Phase 3 study evaluating the 5.6 mg dose in fibromyalgia patients. The trial completed patient enrollment in July and top-line results are expected by year's end, according to the company. Pending positive results from both trials, Tonix expects to file a new drug application with the
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