Tonix Pharmaceuticals Holding Corp. presented clinical data for TONMYA at the 2026 Non-Opioid Pain Therapeutics Summit in Boston, revealing positive results from a Phase 3 trial involving 456 fibromyalgia patients. The RESILIENT study demonstrated that bedtime sublingual administration of TONMYA achieved a statistically significant reduction in weekly average pain scores at Week 14 compared to placebo, with p<0.0001 indicating strong clinical relevance. This finding is particularly important because fibromyalgia affects millions of adults worldwide, and effective treatment options have been limited, especially non-opioid alternatives that address the complex nature of the condition.
The data showed significant improvements beyond pain reduction, including better sleep disturbance, reduced fatigue, and enhanced functional outcomes for patients. TONMYA was well tolerated with low discontinuation rates and primarily mild, self-limited adverse events, supporting its potential as a differentiated, centrally acting non-opioid treatment designed to address both pain and non-restorative sleep in fibromyalgia patients. This dual-action approach is crucial because sleep disturbances are a core symptom of fibromyalgia that often exacerbates pain perception and reduces quality of life.
TONMYA represents the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years, marking a significant advancement in the treatment landscape. The full press release detailing these findings is available at https://ibn.fm/VizLh. For investors seeking additional information about Tonix Pharmaceuticals, the company maintains a newsroom at https://ibn.fm/TNXP where updates are regularly posted.
The implications of these findings extend beyond the immediate patient population to the broader healthcare system and pharmaceutical industry. As concerns about opioid misuse and addiction continue to shape pain management strategies, TONMYA offers a non-opioid alternative that addresses multiple fibromyalgia symptoms simultaneously. The treatment's bedtime administration schedule and sublingual delivery method may improve patient adherence compared to traditional pain medications, potentially leading to better long-term outcomes.
Tonix Pharmaceuticals, a fully-integrated biotechnology company, markets TONMYA alongside two treatments for acute migraine in adults: Zembrace SymTouch and Tosymra. The company's development portfolio includes multiple candidates for central nervous system disorders, immunology, rare diseases, and infectious diseases, though all product development candidates remain investigational with efficacy and safety not yet established for any indication beyond TONMYA's approved use for fibromyalgia.
