- Tonix Pharmaceuticals has selected two contract manufacturing organisations (CMOs) for the potential launch of Tonmya in the U.S. One of the chosen CMOs is Almac Pharma Services.
- Tonix plans to submit a New Drug Application (NDA) to the U.S. FDA in the second half of 2024 for Tonmya.
Tonix Pharmaceuticals, a biopharmaceutical company with marketed products and a development pipeline, has chosen two contract manufacturing organizations (CMOs) for the potential U.S. launch of Tonmya. One of the selected CMOs is Almac Pharma Services, part of the privately-owned Almac Group.
“Dual sourcing is a critical element for the successful commercial launch and supply chain management of a product,” said Seth Lederman, M.D., CEO of Tonix Pharmaceuticals. “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 about the ongoing partnership with Tonix. “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,” he said.
Tonmya is a centrally acting, non-opioid medication. Tonix’s second positive Phase 3 study, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo in participants with fibromyalgia. The study also saw statistically significant and clinically meaningful results in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function. TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies, and no new safety signals were observed.
Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of 2024 for Tonmya for the management of fibromyalgia. This marks a significant step in the company’s journey towards bringing a new non-opioid analgesic to patients suffering from this chronic condition.
Overview of outsourcing trends 
