2nd Phase 3 Study of Low-dose Oral Treatment for Fibromyalgia Gets Underway

2nd Phase 3 Study of Low-dose Oral Treatment for Fibromyalgia Gets Underway
Tonix Pharmaceuticals announced that the first patient has been dosed in RE-AFFIRM, the company's second Phase 3 clinical trial evaluating its cyclobenzaprine HCl sublingual tablets, known as TNX-102 SL, as a low-dose nighttime treatment for fibromyalgia.

TNX-102 SL is a proprietary sublingual (under the tongue) eutectic formulation of cyclobenzaprine (CBP), engineered to deliver a low dose of CBP to the bloodstream through mucosal membrane absorption. CBP works as an antagonist at the serotonin-2A, alpha-1 adrenergic, and histamine H1 receptors. Due to its transmucosal absorption, the proprietary drug candidate avoids first-pass metabolism and decreases exposure to the active metabolite norcyclobenzaprine, an undesirable molecule due to its long plasma half-life. 

“We have taken an important step forward in advancing the clinical development of a much-needed new therapy for the 5 to 15 million people in the U.S. suffering with fibromyalgia by initiating our second pivotal Phase 3 study of TNX-102 SL in fibromyalgia. This is a once-daily bedtime sublingual formulation designed to treat fibromyalgia by improving sleep quality,” Seth Lederman, M.D., president and chief executive officer of Tonix, said in a press release. “given the results of our Phase 2b BESTFIT study, we believe TNX-201 SL could offer ther
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