Cyclobenzaprine reduces pain, improves sleep quality in patients with fibromyalgia

ByErich Martin

Fact checked byShenaz Bagha

Key takeaways:

Patients with fibromyalgia receiving cyclobenzaprine demonstrated less pain compared with patients receiving placebo.
Patients receiving cyclobenzaprine also had improved sleep quality and reduced fatigue.

Patients with fibromyalgia who receive a sublingual tablet form cyclobenzaprine experience reduced daily pain, and improved sleep quality, compared with those who received placebo, according to a press release from the drug’s manufacturer.

“There continues to be a pressing need for new, safe and more tolerable drugs to treat patients with fibromyalgia,” Seth Lederman, MD, CEO of Tonix Pharmaceuticals, said in the press release. “We are looking forward to the results of a planned interim analysis due next quarter for our RESILIENT study, a potentially pivotal confirmatory phase 3 study of TNX-102 SL for the management of fibromyalgia.”

Woman sleeping — Patients with fibromyalgia who receive a sublingual tablet form cyclobenzaprine experience reduced daily pain, and improved sleep quality, compared with those who received placebo, according to a press release. *Image: Adobe Stock*

Lederman presented the early efficacy and safety data for TNX-102 SL, Tonix Pharmaceuticals’ patented form of the drug, at the International Congress on Controversies in Fibromyalgia meeting. According to the release, the phase 3 RELIEF trial showed that patients receiving TNX-102 SL were “significantly” more likely to have reduced daily pain attributed to fibromyalgia, compared with those in the placebo group (P = .01).

The primary endpoint for the study was a 30% or greater pain responder analysis for the test therapy compared to placebo. In all, 47% of patients responded to TNX-102 SL, while 35% responded to placebo (P = .006). Additionally, the 5.6 mg TNX-102 SL group achieved success in secondary endpoints, including improved sleep quality, reduced fatigue and “fibromyalgia-specific global symptomatic and functional recovery,” according to the release.

TNX-102 SL was also well-tolerated, the company said, with both groups demonstrating similar rates of discontinuation. The most common adverse events in patients who received TNX-102 SL was hypoesthesia.

The final enrollment for the study was 503 participants.

Topline data from the RELIEF Study is due in the fourth quarter of 2023, according to the release.

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Tonix press release

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Cyclobenzaprine reduces pain, improves sleep quality in patients with fibromyalgia

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