Tonix Pharmaceuticals announced the publication of pharmacokinetic research on TONMYA (cyclobenzaprine HCl sublingual tablets), the first new FDA-approved treatment for fibromyalgia in adults in more than 15 years. The paper was published in Clinical Pharmacology in Drug Development, the peer-reviewed journal of the American College of Clinical Pharmacology, examining steady-state pharmacokinetics after 20 days of daily dosing.
Mechanism and Dosing
TONMYA was developed for long-term daily dosing at bedtime to target nonrestorative sleep associated with fibromyalgia. The steady-state pharmacokinetic profile at Day 20 is more relevant to the product’s indicated dosing regimen than single-dose pharmacokinetics. The sublingual tablet was designed with a basifying ingredient and cyclobenzaprine-mannitol eutectic to provide transmucosal absorption, deliver maximum plasma levels of cyclobenzaprine during the sleep phase, and bypass first-pass liver metabolism.
TONMYA commercially launched in the U.S. in November 2025. The FDA approved the treatment for fibromyalgia in adults on August 15, 2025, marking the first new prescription medicine approved for the condition in more than 15 years.
Study Findings
A single-center, randomized, open-label study in 60 healthy adult volunteers compared sublingual cyclobenzaprine HCl 5.6 mg to oral cyclobenzaprine HCl extended-release 30 mg capsules over 20 consecutive days. At steady state, exposure to both plasma cyclobenzaprine and norcyclobenzaprine for sublingual tablets was substantially lower than the comparator drug, but when exposures were normalized by dose, cyclobenzaprine bioavailability was higher for sublingual tablets.
On Day 1, sublingual cyclobenzaprine was detectable within one hour of administration, with median time to peak plasma concentration approximately three hours earlier than the oral ER formulation. Daily morning administration was generally safe and well tolerated, with no serious adverse events or treatment discontinuations due to adverse events.
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