Tags: fibromyalgia | tonmya | non-opioid | sublingual

FDA Approves Non-Opioid Daily Pill for Fibromyalgia

woman sitting on bed rubbing a pain in her neck
(Adobe Stock)

Wednesday, 20 August 2025 03:28 PM EDT

The U.S. Food and Drug Administration has approved Tonmya (cyclobenzaprine hydrochloride) sublingual tablets for the treatment of fibromyalgia in adults.

The approval is the first for a fibromyalgia treatment in more than 15 years. It is a first-in-class, non-opioid, once-daily bedtime analgesic.

The approval was based on two phase 3 clinical trials of nearly 1,000 patients, which showed that Tonmya significantly reduced daily pain scores versus placebo at 14 weeks. Compared with those receiving placebo, a greater percentage of participants taking Tonmya experienced a clinically meaningful (≥30 percent) improvement in their pain after three months. Across three phase 3 trials involving more than 1,400 patients, Tonmya was generally well tolerated, with the most common adverse events (incidence, ≥2 percent) being numbness in the mouth, oral discomfort, abnormal product taste, drowsiness, tingling or burning in the mouth, oral pain, fatigue, dry mouth, and aphthous canker sores.

"At Tonix, we recognized the transformative potential of pursuing a new approach with Tonmya for fibromyalgia, a chronic overlapping pain condition that has gone without innovation for many years," Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, said in a statement. "We are hopeful that effectively treating pain with Tonmya could help improve the lives of people with this chronic syndrome."

Approval of Tonmya was granted to Tonix Pharmaceuticals. 

© HealthDay


Health-News
The U.S. Food and Drug Administration has approved Tonmya (cyclobenzaprine hydrochloride) sublingual tablets for the treatment of fibromyalgia in adults. The approval is the first for a fibromyalgia treatment in more than 15 years. It is a first-in-class, non-opioid,...
fibromyalgia, tonmya, non-opioid, sublingual
213
2025-28-20
Wednesday, 20 August 2025 03:28 PM
Newsmax Media, Inc.

Sign up for Newsmax’s Daily Newsletter

Receive breaking news and original analysis - sent right to your inbox.

(Optional for Local News)
Privacy: We never share your email address.
Join the Newsmax Community
Read and Post Comments
Please review Community Guidelines before posting a comment.
 
Find Your Condition
Get Newsmax Text Alerts
TOP

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved
NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved