Tonix Pharmaceuticals Holding Corp. has announced a notable development in its journey towards the potential launch and commercialization of Tonmya™ (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) in the US. 

The biopharmaceutical company has selected two contract manufacturing organizations (CMOs), with one being Almac Pharma Services, a member of the Almac Group, as dual supply sources for Tonmya™.

"Dual sourcing is a critical element for the successful commercial launch and supply chain management of a product," remarked Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, underlining the importance of this strategic move. "We are excited to advance our first internally developed program toward NDA submission and to work with two well-established CMOs for commercial supply and potential launch of Tonmya."

Mark English, VP Operations at Almac Pharma Services, expressed enthusiasm for the ongoing partnership with Tonix, stating, "Having supported the development and clinical trial supply of this drug, we’re thrilled to be continuing our partnership with Tonix to support the commercial launch and ongoing supply of this important new non-opioid analgesic to patients with fibromyalgia, a chronic debilitating disease."

Tonmya™ represents a centrally acting, non-opioid medication with promising prospects for fibromyalgia management. Recent Phase 3 study results from RESILIENT have shown significant efficacy in reducing daily pain compared to placebo, along with positive outcomes in key secondary endpoints related to sleep quality, fatigue reduction, and overall fibromyalgia symptom improvement.

With plans to submit a New Drug Application (NDA) to the US Food and Drug Administration in the second half of 2024, Tonix Pharmaceuticals is poised to further advance its commitment to addressing the needs of patients suffering from fibromyalgia.