FDA Approves First Drug Targeting Sleep in Fibromyalgia
Tonmya, a once-daily sublingual tablet, offers a new nonopioid option for managing fibromyalgia symptoms
The FDA has approved cyclobenzaprine hydrochloride sublingual tablets (Tonmya, Tonix Pharmaceuticals) as the first new therapy for fibromyalgia in over 15 years. The medication is designed to improve nonrestorative sleep, a key driver of pain, fatigue, and cognitive symptoms in this chronic condition.
Study Details
Fibromyalgia affects more than 10 million Americans, the majority of whom are women. Despite its prevalence, treatment options have remained limited and unchanged for more than a decade. Tonmya (formerly TNX-102 SL) represents a novel approach by targeting sleep disturbances that underlie many of the syndrome’s hallmark symptoms.
Approval was based on data from three phase 3 clinical trials: RELIEF, RESILIENT, and RALLY, which together enrolled more than 1,500 patients with fibromyalgia.
Methodology
The RELIEF and RESILIENT trials were double-blind, randomized, placebo-controlled studies including nearly 1,000 patients. Participants took either Tonmya or placebo once daily at bedtime for 14 weeks. The primary endpoint was a reduction in daily pain scores, with additional measures of sleep quality, fatigue, and cognitive symptoms.
The RALLY trial, with over 500 patients, assessed similar outcomes.
Key Findings
In both RELIEF and RESILIENT, Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks.
A greater proportion of patients taking Tonmya experienced at least a 30% improvement in pain.
Benefits extended beyond pain, with improvements in sleep quality, fatigue, and brain fog.
The RALLY trial showed a greater but non significant treatment effect.
The treatment was generally well tolerated. The most common side effects were mild and included oral discomfort, dry mouth, canker sores, drowsiness, and fatigue. No serious adverse events were reported.
Implications for Practice
For patients, this approval means access to the first new FDA-approved fibromyalgia therapy in over 15 years one that addresses the often-overlooked role of poor sleep in chronic pain. Unlike opioids, Tonmya is a nonopioid option that may provide meaningful relief without the risks of dependency.
For healthcare providers, Tonmya represents a shift in treatment strategy. By improving sleep, it may indirectly reduce pain and fatigue, potentially offering a more comprehensive management approach. Clinicians should consider both the benefits and the side effect profile when discussing treatment options with patients.