This summer’s approval of Tonix Pharmaceuticals’ fibromyalgia drug, Tonmya, ended a 15-year dry spell in a market long beset by challenges. But it remains to be seen if this repurposed version of a decades-old drug will give patients the game-changing approach they’re looking for — and it could be a while before another new option comes along.
Fibromyalgia research is progressing as scientists better understand the drivers of chronic pain and regulators push for non-narcotic solutions. The January approval of Journavx, a non-opioid pain signal inhibitor from Vertex Pharmaceuticals, has spurred further interest in the field, and fibromyalgia researchers are exploring new avenues to tackle pain, including psychedelics and GLP-1 obesity drugs.
Tonmya is a reformulated version of the muscle relaxer, cyclobenzaprine hydrochloride. Doctors have prescribed the drug off-label to fibromyalgia patients for years to treat the condition’s widespread pain and fatigue. In phase 3 trials, Tonix’s under-the-tongue tablet produced a statistically significant reduction in daily pain scores compared with placebo, which helped it earn a spot as the fourth FDA-approved drug for the condition.
While some experts argue that Tonmya will likely confer modest symptom improvements, the drug could still appeal to patients to the tune of $219 million to $365 million in yearly revenue, according to Seeking Alpha analysts.
The dearth of other options will likely help give Tonmya traction on the market.
Tonix’s current competition is limited to Pfizer’s Lyrica, Eli Lilly’s Cymbalta and AbbVie’s Savella — all drugs that don’t always make a big difference on fibromyalgia symptoms and can bring significant side effects that cause patients to stop taking them. When those drugs fail, doctors often move to off-label options including antidepressants, gabapentin and muscle relaxers.
For the 10 million Americans struggling with the daily pain and fatigue of fibromyalgia, the wait for effective treatment options has been frustrating and slow. Tonmya could be attractive because it’s easy-to-use and well tolerated.
Still, the opportunity to make a deeper impact remains large.
The next contenders
Tonix’s closest contender, Axsome Therapeutics, was nearing the finish line with its Pfizer-licensed drug, AXS-14, when it faced a setback. After submitting an approval application, the FDA identified a design flaw in one of the biotech’s trials. Axsome is now planning a replacement trial, expected to start in the fourth quarter of 2025.
Many of the other drugs in fibromyalgia’s thin pipeline are in earlier stages. Yet, these rising contenders are taking advantage of other breakthroughs in the space.
Discovering the more recently recognized nociplastic pain, for example, has deepened scientists’ understanding of pain that originates from a malfunction in the central nervous system, not from inflammation or nerve damage. Tonmya addresses this pain processing system misfire.
“Fibromyalgia is the prototype of nociplastic pain syndrome,” said Dr. Seth Lederman, Tonix’s CEO.
This shift in understanding is also leading to a pivot toward new treatment strategies, including psychedelics. Tryptamine Therapeutics’ mid-stage candidate, TRP-8802 was developed with synthetic psilocybin and delivered favorable results in a very small preliminary trial
Companies are also exploring ways to reset the body’s pain system. Scilex Holding Company, which is developing non-opioid pain management options, is preparing for phase 2 with its low-dose naltrexone drug SP-104.
Researchers are also testing whether GLP-1s could make their mark in pain and early observational evidence among patients taking the blockbuster diabetes and weight loss medications indicate they might improve symptoms of fibromyalgia.
Dogwood Therapeutics, meanwhile, is exploring treatments based on the theory that a faulty immune system reaction caused by reactivation of herpes viruses triggers fibromyalgia symptoms.
In the meantime, Tonix is working toward its launch in the fourth quarter of 2025.
“We've been recruiting great people and putting together a great organization, and have everything aligned for a successful launch,” Lederman said.
While Tonmya may not be a revolutionary breakthrough, it’s a step in the right direction.
“We're very well positioned to have a good reception in the market,” Lederman said.
