News Business Tonix Pharmaceuticals Selects Contract Manufacturers for Tonmya™ Launch

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Tonix Pharmaceuticals Announces Selection of Contract Manufacturers for Tonmya™

CHATHAM, N.J., March 20, 2024 — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has taken a significant step toward the potential launch of Tonmya™, a novel non-opioid analgesic for fibromyalgia management. Supported by positive results from two Phase 3 studies, Tonmya™ aims to alleviate the chronic pain and symptoms associated with this debilitating condition.

Dual Supply Sources for Tonmya™

Tonix has strategically chosen two contract manufacturing organizations (CMOs) to ensure a robust supply chain for Tonmya™:

  • Almac Pharma Services: A member of the privately owned Almac Group, Almac Pharma Services will play a pivotal role in the commercial supply of Tonmya™.
  • Second CMO: The second CMO, yet to be disclosed, will complement Almac Pharma Services in providing dual supply sources.

Key Highlights

  • Tonmya™ is a centrally acting, non-opioid medication.
  • The recent Phase 3 study, RESILIENT, demonstrated significant pain reduction compared to placebo in fibromyalgia patients.
  • Secondary endpoints related to sleep quality, fatigue reduction, and overall symptom improvement were also met.
  • TNX-102 SL, the active compound in Tonmya™, exhibited a favorable safety profile.

Next Steps

Tonix plans to submit a New Drug Application (NDA) to the FDA in the second half of 2024, marking a critical milestone in bringing Tonmya™ to patients suffering from fibromyalgia.

Disclaimer: This article is for informational purposes only and does not constitute medical advice. Consult a healthcare professional for personalized recommendations.

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