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FAQ: Tonix Pharmaceuticals' TONMYA™ Phase 3 Fibromyalgia Data and Company Overview
TL;DR
Tonix Pharmaceuticals' TONMYA offers a competitive edge as a first-in-class non-opioid fibromyalgia treatment with proven pain reduction and sleep improvement in Phase 3 trials.
TONMYA demonstrated statistically significant pain reduction and functional improvements in a 14-week Phase 3 trial with 456 fibromyalgia patients using bedtime sublingual administration.
This non-opioid treatment improves quality of life for fibromyalgia patients by addressing both chronic pain and sleep disturbances with minimal side effects.
TONMYA represents the first new FDA-approved fibromyalgia medicine in over 15 years, showing promise beyond pain relief to enhance sleep and daily function.
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Tonix Pharmaceuticals presented positive Phase 3 clinical data for TONMYA™ (previously TNX-102 SL) in treating fibromyalgia at the 2026 Non-Opioid Pain Therapeutics Summit, showing significant pain reduction and improvements in sleep disturbance, fatigue, and functional outcomes.
In the RESILIENT trial involving 456 fibromyalgia patients, bedtime sublingual TONMYA demonstrated statistically significant reduction in weekly average pain scores at Week 14 versus placebo (p<0.0001), along with significant improvements in sleep disturbance, fatigue, and functional outcomes, with good tolerability and low discontinuation rates.
TONMYA is the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years, representing a first-in-class, non-opioid analgesic designed to address both pain and non-restorative sleep in fibromyalgia patients.
The data were presented at the 2026 Non-Opioid Pain Therapeutics Summit held on January 29, 2026, in Boston, Massachusetts.
Tonix markets FDA-approved TONMYA™ for fibromyalgia, plus two treatments for acute migraine in adults: Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray).
Tonix's development portfolio includes treatments for central nervous system disorders (acute stress reaction, acute stress disorder, major depressive disorder), immunology (organ transplant rejection, autoimmunity, cancer), rare diseases (Prader-Willi syndrome), and infectious diseases (mpox, smallpox, Lyme disease, biological threats).
TONMYA was well tolerated in the Phase 3 trial, with low discontinuation rates and primarily mild, self-limited adverse events.
The full press release can be viewed at https://ibn.fm/VizLh.
All of Tonix's product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and they have not been approved for any indication.
Tonix has a contract with the U.S. Department of Defense's Defense Threat Reduction Agency (DTRA) for up to $34 million over five years for TNX-4200, a broad-spectrum antiviral agent, and the OASIS study for TNX-102 SL in acute stress disorders is funded by the U.S. Department of Defense.
Curated from InvestorBrandNetwork (IBN)
