Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced the publication of a study examining the steady-state pharmacokinetics of TONMYA after 20 days of daily dosing in Clinical Pharmacology in Drug Development, a peer-reviewed journal.

The study evaluated TONMYA (cyclobenzaprine HCl sublingual tablets) in 60 healthy adult volunteers over 20 consecutive days. Participants received either sublingual cyclobenzaprine HCl 5.6 mg or oral cyclobenzaprine HCl extended-release 30 mg capsules once daily.

Results showed that at steady state, exposure to plasma cyclobenzaprine and norcyclobenzaprine for the 5.6 mg sublingual tablets was lower than the 30 mg oral capsules. When normalized by dose, the sublingual formulation demonstrated higher cyclobenzaprine bioavailability compared to oral extended-release capsules.

On the first day, sublingual cyclobenzaprine was detectable within one hour, with median time to peak plasma concentration occurring three hours earlier than the oral formulation. At steady state on day 20, the sublingual formulation maintained a two-hour earlier peak time.

The study found daily morning administration of sublingual cyclobenzaprine HCl 5.6 mg over 20 days was generally safe and well tolerated. No serious adverse events or treatment discontinuations due to adverse events occurred. The most commonly reported adverse events with sublingual tablets occurring at higher rates than oral capsules were oral hypoesthesia, abnormal product taste, somnolence, back pain, and fatigue.

TONMYA received FDA approval on August 15, 2025, for treating fibromyalgia in adults and commercially launched in the U.S. in November 2025. The drug represents the first new FDA-approved treatment for fibromyalgia in more than 15 years, according to the company's statement.