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Thursday, 21 August 2025

Tonmya: a new drug for fibromyalgia?

Medscape has reported that the USA’s drug regulator, the FDA, has approved a new, first-in-class drug for Fibromyalgia.

    “The FDA has approved cyclobenzaprine hydrochloride sublingual tablets (Tonmya, Tonix Pharmaceuticals), a first-in-class, nonopioid treatment for adults with fibromyalgia, a chronic pain syndrome that affects more than 10 million Americans, roughly 80% of whom are women”.

The article goes on to describe the testing of the drug, published in Pain Medicine on 8th July 2025, which indicates a 30% improvement in pain (which, of course, means that 70% of the pain remains). And the drug was “generally well-tolerated with no serious side effects”. Good new indeed, if it were only true!

So what does the Drugs.com website say about Tonmya? It can be found here, and I summarise it below - without comment, other than to provide a link to the safe and effective treatment of fibromyalgia with homeopathy.

“Common Tonmya side effects

The most common Tonmya side effects are oral pain, fatigue, dry mouth, numbness in the mouth (oral hypoesthesia), oral discomfort, abnormal product taste, drowsiness, canker sores, mouth tingling, pricking, or burning.

“Serious side effects

Tonmya may have serious side effects, including:

“Serious allergic reaction: Tell your health care provider right away if you experience symptoms of an allergic reaction, such as difficulty breathing, hives, swelling of the face or tongue, or itching.

“Embryofetal Toxicity. If Tonmya is used two weeks before conception and through the first trimester of pregnancy, it may cause neural tube defects, based on animal data….

“Serotonin Syndrome: Potentially life-threatening serotonin syndrome has been reported with cyclobenzaprine when used in combination with other drugs….

“Tricyclic Antidepressant-like Adverse Reactions: Tricyclic Antidepressant (TCAs) have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke…..
TCAs lower the seizure threshold and are associated with serious CNS reactions. If clinically significant CNS symptoms develop, consider discontinuation of Tonmya.

“Atropine-like Adverse Reactions: This medicine should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medications.

“CNS Depression and Risk of Operating a Motor Vehicle or Hazardous Machinery: Patients using this medicine should not operate a motor vehicle or other dangerous machinery until they are reasonably certain that Tonmya will not affect their ability to engage in such activities.

“Oral Mucosal Adverse Reactions: This medicine may cause severe oral side effects…..

“This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

So please decide for yourself. Is this new drug really ““generally well-tolerated with no serious side effects”?

And for the safe and effective homeopathic treatment of fibromyalgia, which genuinely has no side effects or adverse reactionsgo to this link.