Tonix Pharmaceuticals launches TONMYA, a first-in-class non-opioid Fibromyalgia therapy

Описание: Tonix Pharmaceuticals Holdings CEO Dr. Seth Lederman joined Steve Darling from Proactive to announce a major milestone for the company and for patients: TONMYA is now commercially available by prescription at pharmacies across the United States. TONMYA is a first-in-class, non-opioid analgesic designed specifically for adults with fibromyalgia and is taken once nightly at bedtime.

Dr. Lederman told Proactive that this marks a transformative moment for the estimated 10 million Americans living with fibromyalgia, a chronic condition characterized by widespread pain, sleep disturbance, fatigue, and impaired quality of life. TONMYA offers a novel therapeutic option that directly targets the condition’s core, debilitating symptom—chronic pain—while also showing positive effects on associated symptoms.

The commercial launch follows a substantial clinical development program, including the recently published RESILIENT Phase 3 trial in Pain Medicine. The study evaluated TONMYA on primary endpoints measuring pain reduction and secondary endpoints assessing overall patient-reported improvement, symptom severity, sleep quality, functional impact, and fatigue. The published findings reinforce TONMYA’s role as a meaningful new option in a field where therapeutic advances have been limited.

Regulatory approval incorporated efficacy and safety results from two double-blind, randomized, placebo-controlled Phase 3 trials involving nearly 1,000 patients. In both studies, TONMYA demonstrated a statistically significant reduction in daily pain scores at 14 weeks, meeting the primary endpoint. A higher proportion of patients receiving TONMYA also achieved clinically meaningful pain improvement after three months compared with placebo, underscoring its real-world therapeutic relevance.

With its U.S. pharmacy availability now in place, TONMYA becomes a first-in-class, non-opioid option designed to address the multi-dimensional burden of fibromyalgia—and represents a significant step forward for patients seeking relief and improved daily functioning.


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