FDA Approves New Sublingual Nonopioid Treatment for Fibromyalgia

The U.S. Food and Drug Administration (FDA) has granted approval for Tonmya (cyclobenzaprine hydrochloride) sublingual tablets as a new option for managing fibromyalgia in adults. This milestone marks the first FDA-approved treatment for fibromyalgia in over 15 years, offering hope to millions affected by this chronic condition. Tonmya is a first-in-class, nonopioid, once-daily medication designed to be taken at bedtime, aiming to alleviate persistent pain associated with fibromyalgia.

The approval was supported by robust clinical trial data involving nearly 1,000 patients. These studies demonstrated that Tonmya significantly lowered pain scores compared to placebo after 14 weeks of treatment. Additionally, a higher proportion of patients taking Tonmya experienced a meaningful reduction in pain—defined as at least 30% improvement—after three months. The medication was generally well tolerated, with side effects such as numbness, oral discomfort, abnormal taste, drowsiness, burning sensations in the mouth, oral pain, fatigue, dry mouth, and canker sores being the most common.

Tonix Pharmaceuticals, the manufacturer of Tonmya, expressed optimism about this new therapeutic option. Dr. Seth Lederman, the company’s CEO, highlighted the importance of this innovative approach for fibromyalgia treatment, a condition characterized by widespread pain and often associated with other symptoms like fatigue and sleep disturbances. The approval underscores the urgent need for effective, nonopioid pain management options for fibromyalgia patients.

Individuals interested in this new treatment may consult their healthcare providers to determine if Tonmya is suitable for their condition. This approval signifies a substantial advancement in the management of fibromyalgia, offering hope for improved quality of life for those living with this challenging syndrome.