TNXP News & Events

Tonix Pharmaceuticals announced an agreement with a leading group purchasing organization that provides coverage to approximately 35M U.S. commercial lives for Tonmya, a cyclobenzaprine HCl sublingual tablet. "This agreement is an important milestone in expanding patient access to TONMYA," said Seth Lederman, president and CEO of Tonix Pharmaceuticals. "We are encouraged by this first partnership with managed care and look forward to continuing to pursue additional coverage across commercial and government channels." Tonix also continues to progress discussions with Medicare and Medicaid, where Tonmya is currently covered under Medicaid in 38 states for approximately 55M lives. "TONMYA is a first-in-class non-opioid analgesic indicated for the treatment of fibromyalgia in adults. TONMYA is the first new FDA-approved treatment option for fibromyalgia in over 15 years. Fibromyalgia patients have experienced dissatisfaction with available therapies, with 85% of first-line treatments failing due to efficacy and tolerability."

Tonix Pharmaceuticals announced presentation of Phase 1 data and plans for an adaptive Phase 2 field study of TNX-4800 for the prevention of Lyme disease in the U.S., at the 4th Annual Ticks and Tickborne Diseases Symposium. The Phase 2 study is expected to initiate in the first half of 2027, pending FDA agreement. The Phase 1 study was conducted by a team at UMass Chan Medical School led by Mark S. Klempner, MD, Professor of Medicine at UMass Chan and an inventor of TNX-4800. The adaptive Phase 2 field study is being planned by Tonix, which licensed TNX-4800 from UMass Chan Medical School in 2025. "We plan to initiate an adaptive Phase 2 field study in the first half of 2027 pending FDA agreement," said Seth Lederman, MD, CEO of Tonix Pharmaceuticals. The company plans to study TNX-4800 in a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study to evaluate the efficacy of a two-dose regimen of TNX-4800 SC, in preventing the first occurrence of confirmed Lyme disease during the primary efficacy surveillance period. The two-dose regimen of TNX-4800 was selected for the Phase 2 field study based on the pharmacokinetic results of the Phase 1 study. Each fixed dose is expected to provide exposures comparable to the 5 mg/kg dose evaluated in Phase 1. The first dose will be administered in the Spring and the second booster dose will be administered two months later. Participants will include adolescents and adults 16 years of age and older in Lyme-endemic areas in the U.S. The primary endpoint will be the prevention of Lyme disease for six months following the initial dose. The company has scheduled a Type C meeting with the FDA early in the third quarter of 2026 to discuss the planned adaptive Phase 2 field study design. The company expects to have Good Manufacturing Practice investigational product available for clinical testing in early 2027.

Tonix Pharmaceuticals announced the publication of a paper, "Steady-State Pharmacokinetic Properties of TNX-102 SL, a Sublingual Tablet Formulation of Cyclobenzaprine Hydrochloride, With Daily Dosing in Healthy Volunteers: A Randomized, Open-Label Trial," in Clinical Pharmacology in Drug Development, the peer-reviewed journal of the American College of Clinical Pharmacology. Tonmya was investigated under the designation TNX-102 SL. The publication reports findings from a single-center, randomized, open-label, multiple-dose, parallel-group pharmacokinetic study conducted in 60 healthy adult volunteers. Participants were randomized 1:1 to receive either sublingual cyclobenzaprine HCl 5.6 mg or oral cyclobenzaprine HCl extended-release 30 mg capsules once daily for 20 consecutive days. At steady state, exposure to both plasma cyclobenzaprine and norcyclobenzaprine for sublingual tablets 5.6 mg was substantially lower than that to the comparator listed drug, oral cyclobenzaprine HCl ER 30 mg capsules. Importantly, when exposures were normalized by dose, cyclobenzaprine bioavailability is higher for sublingual tablets at 5.6 mg relative to oral ER 30 mg capsules. Both treatments had comparable metabolic profiles of Phase I and II metabolites in human plasma. These pharmacokinetic results are consistent with the use of sublingual cyclobenzaprine HCl tablets at 5.6 mg to target nonrestorative sleep in fibromyalgia, reduce pain, and potentially improve other symptoms of the condition. 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 capsule formulation. The sublingual formulation demonstrated markedly higher cyclobenzaprine bioavailability when exposures were normalized by dose. Daily morning administration of sublingual cyclobenzaprine HCl 5.6 mg over 20 days was generally safe and well tolerated. There were no serious adverse events or treatment discontinuations due to adverse events. All treatment-emergent adverse events were mild or moderate in severity. The most commonly reported adverse events with sublingual tablets occurring at rates higher than oral ER capsules were oral hypoesthesia, abnormal product taste, somnolence, back pain, and fatigue. Since Tonmya is intended for bedtime administration, the effects of somnolence are expected to be an attribute for bedtime dosing when sleepiness effects are beneficial. No metabolites unique to the sublingual route of administration were identified.