In a milestone moment for chronic pain management, Tonix Pharmaceuticals announced on August 15, 2025, that its novel sublingual therapy Tonmya has received approval from the U.S. Food and Drug Administration (FDA) – marking the first new drug for Fibromyalgia in more than 15 years. The medication is now commercially available by prescription in U.S. pharmacies, offering new hope to the roughly 10 million American adults affected by this debilitating condition.

A first-in-class, non-opioid approach

Tonmya represents a new therapeutic class: a non-opioid, once-daily sublingual tablet designed for bedtime use. Importantly, Tonmya’s mechanism doesn’t rely on opioid pathways: instead, it modulates receptors including 5-HT2A, α1, H1, and M1. Tonix notes that its formulation targets sleep architecture and central pain processing: a dual approach that could help address both pain and nonrestorative sleep, key components of fibromyalgia.

Proven in clinical trials

The FDA’s approval rests on data from two Phase 3 randomized, double-blind, placebo-controlled trials (RELIEF and RESILIENT), which together enrolled nearly 1,000 adults with fibromyalgia. In both trials, patients receiving Tonmya experienced statistically significant reductions in daily pain scores after 14 weeks compared to placebo -the primary endpoint.  Moreover, a larger proportion of Tonmya-treated patients achieved a clinically meaningful ≥ 30 % improvement in pain after three months.

A long-awaited option for patients

As noted by Tonix CEO Seth Lederman, the approval of Tonmya reflects the company’s long-term commitment to delivering a therapeutic advance that was overdue. This success mirrors broader trends in the non-opioid pain landscape, where the past year has seen multiple long-anticipated clinical milestones, signalling a transition from exploratory promise to real commercial viability. One of the most notable being the recent FDA approval of Vertex’s size tribune (Journavx^™), the first new non-opioid oral analgesic in decades.

For the first time in over a decade, chronic pain research is no longer focused on a single mechanism. It has evolved into a multi-mechanistic, competitive landscape, featuring a diverse array of scientific approaches and therapeutic targets.

Both Gregory Sullivan, Chief Medical Officer of Tonix Pharmaceuticals, and Richard Scranton, Vice President of Pain Clinical Development at Vertex, will be speaking at the Non-Opioid Pain Therapeutics Summit this January, joining a world-class faculty that you can explore . Highlights of the agenda include exploration of novel targets beyond NaV1.8, advancements in patient-reported outcomes (PROs) for pain clinical trials, evaluation of gold-standard human pain models and a pharma perspective panel featuring leaders from Eli Lilly, AbbVie, Novartis, and Merck.

Join over 80 discovery, preclinical, translational, and clinical experts driving momentum in non-opioid pain therapeutics in Boston to give your team a headstart in the pain wave in 2026.