Tonmya™ (cyclobenzaprine HCl sublingual tablets) is now available for the treatment of adults with fibromyalgia, according to Tonix Pharmaceuticals.
Tonmya is supplied as a sublingual tablet containing cyclobenzaprine hydrochloride that is taken once daily at bedtime. Its approval was supported by multiple clinical trials demonstrating a reduction in pain among patients treated with Tonmya compared with placebo. Recently published data also showed Tonmya led to improvements in other fibromyalgia symptoms including sleep disturbance and fatigue.
“The availability of Tonmya is a momentous day for Tonix, providing the estimated 10 million people living with fibromyalgia a novel treatment that has been shown to address the debilitating, core symptom of this disease, widespread pain,” said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals. “After more than 15 years without innovation for this disease, we are honored to bring this new treatment option to patients in partnership with the full fibromyalgia community including researchers, patients, and investigators.”
Tonmya is contraindicated in patients with a hypersensitivity to cyclobenzaprine, with concomitant use of monoamine oxidase inhibitors (MAOI) or within 14 days of discontinuation of an MOAI, during the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure, and in those with hyperthyroidism.
The most common adverse reactions reported with Tonmya were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer. The prescribing information also includes warnings and precautions related to embryo-fetal toxicity, serotonin syndrome, tricyclic antidepressant-like adverse reactions, atropine-like adverse reactions, and central nervous system depression.
The recommended dosage of Tonmya is 2.8mg once daily at bedtime on days 1 to 14. Starting at day 15, the dose is increased to 5.6mg once daily at bedtime. For geriatric patients and those with mild hepatic impairment, the maximum recommended dosage is 2.8mg once daily at bedtime. Tonmya is not recommended for patients with moderate to severe hepatic impairment. Additionally, pregnancy testing is recommended for females of reproductive age prior to initiating treatment.
This article originally appeared on MPR