Tonix Pharmaceuticals, a company developing next-gen therapies for disorders of the central nervous system, including fibromyalgia and post-traumatic stress disorder (PTSD), has completed enrollment in its Phase 3 AFFIRM clinical trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in fibromyalgia.
TNX-102 SL is a proprietary sublingual (under the tongue) eutectic formulation of cyclobenzaprine (CBP) that is 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 sublingual transmucosal absorption, the proprietary drug candidate avoids first-pass metabolism and decreases exposure to the active metabolite norcyclobenzaprine, a not-so-desirable molecule due to its long plasma half-life. The U.S. FDA has conditionally agreed to the name Tonmya for TNX-102 SL, but it is still an Investigational New Drug (IND) and has not yet been approved for any indication.
The 12-week Phase 3 AFFIRM trial is currently being conducted in 35 U.S. locations. Its 500-patient goal per protocol has been achieved. The trial is a randomized, double-blind, placebo-controlled clinical study designed to assess the efficacy of TNX-102 SL for the management of fibromyalgia.
The treatment is administered under the tongue once a day at bedtime over the course of 12 weeks. The primary outcome assessment for the AFFIRM study will be an FDA-cleared pain responder analysis, defined as the proportion of patients who report a minimum of a 30 percent reduction in pain from baseline at the end of the 12-week treatment period.
“We are developing a new medicine for fibromyalgia because there are still inadequate therapy options despite its prevalence as one of the most common chronic pain conditions,” said Tonix President and CEO Seth Lederman, M.D., in a press release. “Many individuals with fibromyalgia cannot tolerate the existing medicines or achieve a durable therapeutic benefit from them according to the U.S. Food and Drug Administration (FDA) October 2014 Patient-Focused Drug Development Initiative Fibromyalgia Report.
“The completion of patient enrollment in our flagship development program is an important clinical milestone, and we look forward to reporting top-line data from this trial in the third quarter of 2016,” Lederman added.
Top-line results are expected later this year.