Tonix released a peer-reviewed paper detailing a randomized, open-label, multiple-dose pharmacokinetic study in 60 healthy volunteers. Participants received either two 2.8 mg TONMYA sublingual tablets (5.6 mg total) or a 30 mg oral extended-release cyclobenzaprine capsule once daily for 20 consecutive days. The trial evaluated plasma levels of cyclobenzaprine and its metabolite, norcyclobenzaprine, on Day 1 and at steady state on Day 20. Results were published in Clinical Pharmacology in Drug Development to elucidate the profile of daily bedtime dosing.

At steady state on Day 20, sublingual TONMYA exhibited substantially higher dose-normalized bioavailability than the oral ER comparator, despite lower absolute exposure. Median time to peak plasma concentration (tmax) occurred two hours earlier for TONMYA (five hours) compared with the ER capsule (seven hours). On Day 1, sublingual cyclobenzaprine was detectable within one hour and achieved peak levels three hours sooner than the ER formulation. Both formulations showed comparable metabolic profiles of Phase I and II metabolites.

Daily administration of TONMYA for 20 days was generally well tolerated with no serious adverse events or discontinuations. All reported treatment-emergent adverse events were mild or moderate. The most common events with sublingual tablets—oral hypoesthesia, abnormal taste, somnolence, back pain and fatigue—are consistent with its bedtime use, where somnolence is a desirable effect.

These pharmacokinetic data reinforce TONMYA’s design for night-time dosing to target nonrestorative sleep in fibromyalgia, leveraging rapid transmucosal absorption and receptor activity at 5-HT₂A, α₁-adrenergic, H₁ and M₁ sites. Earlier and higher peak cyclobenzaprine levels during sleep hours may improve slow wave sleep and reduce pain. The profile supports its FDA-approved indication as the first new fibromyalgia therapy in over 15 years, with potential benefits for symptom relief and quality of life.