FDA Approves First New Fibromyalgia Drug in 15 Years

By Pat Anson

Fibromyalgia sufferers who have yearned for new treatments finally have one. Tonix Pharmaceuticals says the Food and Drug Administration has approved Tonmya for the treatment of fibromyalgia in adults -- the first new FDA-approved therapy for fibromyalgia in over 15 years.

Fibromyalgia is a poorly understand chronic pain condition that affects about 10 million Americans, most of them women. It causes an array of symptoms, such as widespread body aches, fatigue, insomnia, mood disorders and brain fog.

Until now, the FDA has approved only three medications for fibromyalgia: duloxetine (Cymbalta), pregabalin (Lyrica), and milnacipran (Savella). Many patients consider the drugs ineffective or have too many side effects.

“The FDA approval of Tonmya as a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the U.S. suffering from the debilitating pain this condition causes,” Seth Lederman, MD, CEO of Tonix, said in a press release. “At Tonix, we recognized the transformative potential of pursuing a new approach with Tonmya for fibromyalgia, a chronic overlapping pain condition, that has gone without innovation for many years.”

Tonmya is more of a sleep aid than an analgesic. The tablet is a new, faster-acting formulation of an old drug: cyclobenzaprine hydrochloride (Flexeril), a muscle relaxant that was originally developed as an antidepressant. Tonmya is meant to be taken before bedtime sublingually, to be dissolved under the tongue for rapid absorption into the bloodstream.

Tonix believes that improving sleep quality, specifically restorative sleep, is the key to reducing fibromyalgia symptoms. Poor sleep not only worsens pain, but causes anxiety and depression, which are common features of fibromyalgia. Pain, insomnia, and mood disorders become a vicious cycle when fibromyalgia is poorly treated.

In a Phase 3 clinical study, fibromyalgia patients taking Tonmya reported better sleep and less fatigue after three months, which coincided with at least a 30% reduction in pain in about half of patients. Tonmya was generally well tolerated, with fewer side effects than the other three fibromyalgia medications.

It’s notable that all of the FDA-approved drugs for fibromyalgia are neither new or novel. They were originally developed for other purposes — to relieve depression or seizures — and are simply being repurposed as fibromyalgia treatments.

“The chronic pain of fibromyalgia is debilitating to every aspect of a person’s life, including causing sleep disturbance and fatigue, all of which can negatively impact someone’s ability to carry out their daily activities,” said Sharon Waldrop, founder of the Fibromyalgia Association. “For over 15 years, this community has been underserved and waiting for new treatment options. This approval is a promising step forward and brings renewed hope to millions.”

Tonmya is expected to become available in the fourth quarter of 2025.

We Need Better Treatments for Long Covid, Fibromyalgia, Chronic Fatigue and More

By Dr. Seth Lederman

Headlines about COVID have faded, and the United States will soon turn the page on public emergency status for the pandemic. The virus no longer dominates most of our lives, yet there are still thousands of new hospitalizations daily and an estimated 15 million Americans currently suffer from Long COVID.

The deep impact of long-haul cases has contributed to a surge of patients with disabling conditions, who are often misdiagnosed or treated ineffectively. More than one in five people infected with COVID-19 develop Long COVID and its constellation of physical and neurological symptoms. The persistent pain, fatigue, sleep problems and brain fog are similar to two other post-infectious syndromes, fibromyalgia and chronic fatigue syndrome (CFS/ME).

A recent study of both conditions and Long COVID documented that the physical and cognitive impairments of Long COVID were exacerbated in people previously diagnosed with CFS/ME or fibromyalgia. These types of chronic overlapping pain conditions have long been recognized by the National Institutes of Health (NIH), and the president’s National Research Action Plan on Long COVID similarly makes the connection between CFS/ME and Long COVID.

More than 50 million people struggle with these neurological illnesses every year in our country, and the burden of their chronic diseases comes at incalculable personal harm, along with billions of dollars in healthcare costs and lost productivity. 

There is one common denominator among all these unrelenting illnesses: the human brain. Physicians like me who study infectious and neurological diseases know that getting a drug’s active ingredients into the brain is not easy. Unlike biologic drugs, which are usually administered by injection, the only medications that can cross from the bloodstream into the brain are small-molecule drugs.

But big pharmaceutical companies have largely abandoned the development of new small-molecule therapeutics, instead pursuing biologic drugs which tend to be more expensive and profitable. That is because of a complex mix of federal laws granting longer market exclusivity to biologics, patent law changes that remove economic incentives to develop new small-molecule therapeutics, and mounting Food and Drug Administration hurdles.

Yet small-molecule drugs can be highly effective and life-changing, as well as relatively cost-effective to manufacture and distribute. They are our best hope for offering real relief to people struck by cruel conditions rooted in brain function.

As we pick up the pieces from a once-in-a-generation pandemic, we cannot ignore the rise in debilitating post-infectious diseases. In a sense, the people afflicted by these illnesses are living with invisible scars from the infections that preceded their current illnesses. There is an urgent need to help them by restoring incentives for small-molecule drug development and streamlining regulatory processes for new treatments.

The government should be accelerating efforts to expand its support for new drug therapies to address fibromyalgia, CFS/ME, Long COVID, and other illnesses that originate in the brain. The untapped potential of emerging therapeutics is unacceptable, as is the fact that many patients’ symptoms are frequently misinterpreted or dismissed.

It is good news that the Advanced Research Project Agency for Health has been established within NIH to pursue biomedical breakthroughs. But our country could still be doing more on this front. Congress has the power to legislate a more level playing field for small-molecule drug development, correcting decades of bureaucratic bias.

Lawmakers should appropriate more resources to fast-track clinical trials and scale-up delivery of novel therapies for post-infectious diseases. Public-private partnerships could also go a long way towards bridging the gap between treatments that would transform patients’ lives and their current limited options.

We know from our experience with COVID that medical science is capable of swift and significant breakthroughs. Our public health system should be equipped to readily diagnose and effectively treat people with fibromyalgia, CFS/ME, Long COVID, and similar devastating illnesses.

While the symptoms of these diseases are often not visible, our responsibility to provide patients with advanced and effective care is very real. For millions of Americans and their families, the time for better treatments is now.

Seth Lederman, MD, is a physician-scientist and CEO of Tonix Pharmaceuticals, a company developing technologies to treat Long COVID, PTSD, fibromyalgia, and other diseases.

Study of Fibromyalgia Drug Continues Despite Disappointing Results

By Pat Anson, PNN Editor

New Jersey-based Tonix Pharmaceuticals says it will proceed with a Phase 3 study of a drug to treat fibromyalgia, despite disappointing results that caused the company to stop enrolling new patients.

Based on an interim analysis of the first 337 participants enrolled in the RALLY study, an independent data monitoring committee found that TNX-102 SL was unlikely to demonstrate a statistically significant improvement in pain compared to placebo. No issues were reported on the safety of the drug.

The finding of the monitoring committee is somewhat surprising, because Tonix recently reported results from another Phase 3 study, which found that TNX-102 SL significantly reduced pain compared to placebo and also improved sleep, fatigue and function in fibromyalgia patients.

“We are surprised and disappointed that the interim analysis did not support continued enrollment in this Phase 3 RALLY study, especially considering the previous Phase 3 RELIEF study, which had a similar design and achieved statistical significance on the primary endpoint,” said Seth Lederman, MD, President and CEO of Tonix. “These results underscore the difficulty in managing and treating fibromyalgia.”

Lederman said the company would continue its Phase 3 trial with the patients who are already enrolled and report the results in the fourth quarter of 2021. It will then determine its next steps.

TNX-102 SL is a sublingual tablet formulation of cyclobenzaprine hydrochloride, a muscle relaxant and anti-depressant that’s being evaluated as a daily bedtime treatment for fibromyalgia. The goal is to see if TNX-102 SL helps fibromyalgia patients sleep better.  In addition to fibromyalgia, TNX-102 SL is also being considered as a treatment for post-traumatic stress disorder (PTSD), alcohol use disorder and agitation in Alzheimer’s disease.

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep and depression. The National Institutes of Health estimates about 5 million Americans have fibromyalgia. Most people diagnosed with fibromyalgia are women, although men and children can also be affected.

The FDA has approved only three drugs to treat fibromyalgia; the antidepressants duloxetine (Cymbalta) and milnacipran (Savella), and the anti-seizure medication pregabalin (Lyrica). Many fibromyalgia patients say the drugs are ineffective and have unwelcome side effects. A recent analysis found little evidence to support the long-term use of any medication or therapy to treat fibromyalgia.