FDA grants fast track designation to cyclobenzaprine tablets for fibromyalgia
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Key takeaways:
- Tonmya significantly reduced daily pain vs. placebo in a phase 3 trial in fibromyalgia.
- Fast track designation expedites the review of drugs to treat serious diseases with unmet needs.
The FDA has granted fast track designation to a sublingual tablet form of the muscle relaxant cyclobenzaprine hydrochloride for the management of fibromyalgia, according to a press release from the manufacturer.
Tonix Pharmaceuticals reported that its patented form of the drug, Tonmya (cyclobenzaprine HCl), received the designation following results of the phase 3 RESILIENT study, which were released in December. In that study, Tonmya significantly reduced daily pain compared with placebo in patients with fibromyalgia (P = .00005). The company stated it plans to submit a new drug application to the FDA for the therapy in the second half of 2024.
“The FDA’s decision to grant Tonmya fast track designation supports our goal of bringing this well tolerated, non-opioid analgesic treatment option to the market in 2025,” Tonix CEO Seth Lederman, MD, said in the release. “The designation underscores the importance of addressing the unmet needs of fibromyalgia patients, who report dissatisfaction with current treatment options.
“If approved by the FDA, we expect Tonmya to become the first new pharmacotherapy for fibromyalgia in over 15 years,” he added. “The new drug application being prepared supports Tonmya’s potential position as a first line therapy for fibromyalgia, indicated for long-term daily use at bedtime.”
The FDA’s fast track process is designed to expedite the review of therapies intended to treat serious conditions with unmet needs, and ultimately bring new medicines to patients sooner. Companies whose drugs receive the designation are eligible for more frequent interactions with the FDA during clinical development.
Tonix Pharmaceuticals additionally plans to request priority review designation for Tonmya in fibromyalgia, according to the release. If granted, FDA may accelerate the review of the new drug applications.
According to Tonix, further data from the RESILIENT study demonstrated that Tonmya achieved not just its primary endpoint — reducing daily pain vs. placebo — but also all six key secondary endpoints. These related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function (all P .001).
Prior to that study, Tonix announced in March 2022 that the drug had failed to achieve statistical significance in reducing fibromyalgia pain vs. placebo in the phase 3 RALLY study.
Further back, the phase 3 RELIEF trial, which was completed in December 2020, saw Tonmya achieve its pre-specified primary endpoint of daily pain reduction compared with placebo (P = .01), as well as activity in key secondary endpoints, according to Tonix.
In both the RESILIENT and RELIEF studies, the most common treatment-emergent adverse event was tongue or mouth numbness at the administration site, which the company described as “temporally related to dosing, self-limited, never rated as severe, and rarely led to study discontinuation.”
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