FDA Approves First New Fibromyalgia Drug in 15 Year
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.
How Fibromyalgia Is Treated: Medication, Exercise, Diet, and More
Many treatment options are available to address fibromyalgia’s various symptoms, so treatment for fibromyalgia should be multifactorial, individualized, and based on what specific issues and symptoms are affecting you most.
Fibromyalgia is a common but often misdiagnosed and misunderstood disorder. This chronic condition causes widespread muscle pain, known as myalgia, and extreme tenderness in many areas of the body. Many people with fibromyalgia experience other symptoms in addition to musculoskeletal pain, including sleep disturbances, fatigue,
headaches, and mood issues like depression and anxiety.
In the United States, fibromyalgia affects about 2 percent of people by age 20. That increases to about 8 percent of people by age 70. It’s the most common cause of generalized musculoskeletal pain in women 20 to 55 years old. Fibromyalgia is more common in women than men.
Many fibro patients report a life of chronic pain. Muscles and tendons are excessively irritated by various painful stimuli in people with fibromyalgia. “It can be anything sensory — touch, smell, light, sound, taste,” says Kevin Hackshaw, MD, a rheumatologist who specializes in treating patients with fibromyalgia at The Ohio State University Wexner Medical Center in Columbus.
“Any of these sensory nerves can lead to enhanced signaling or some form of discomfort,” says Dr. Hackshaw, who is also an associate professor in the division of rheumatology and immunology. This is thought to be due to a heightened perception of pain, called central sensitization.
It’s not clear why or how some people develop central sensitization, but it may have a genetic component, with some people predisposed to a heightened sense of pain. A lot of speculation exists as to why this is the case, says Dr. Hackshaw.
Quality of Life with Fibromyalgia
Quality of life varies for each person with fibromyalgia, says Tami Stackelhouse, a certified health coach who has fibromyalgia, founder of the International Fibromyalgia Coaching Institute, and author of Take Back Your Life: Find Hope and Freedom From Fibromyalgia Symptoms and Pain. For many fibro patients, the condition has a significantly negative impact on quality of life and ability to partake in and enjoy everyday activities.
Many fibro patients have constant pain and fatigue, though everything from parenting to chores must go on. “Activities that take a lot of energy are difficult,” says Stackelhouse. “Even standing in the shower and washing your hair can be difficult.”
That’s why you have to make adjustments, she says. Stackelhouse, for example, breaks up activities like showering, washing her hair one day and her body another day. “My fibromyalgia impacts every decision that I make from what I eat, to the things I do, to how I structure my day,” she says. “I do my best to stay well so I make certain choices.”
Dr. Hackshaw says that he has patients complete a fibromyalgia impact questionnaire at each visit. It surveys their ability to conduct daily activities like vacuuming, walking, driving, and shopping. It allows him to see how patients are doing with managing their symptoms and if medications have been effective.
You can use our ArthritisPower app to track your symptoms and share your results with your doctor.
Treatment for Fibromyalgia: The Big Picture
There’s not necessarily a straightforward or universal way to treat fibromyalgia, as the condition affects each patient differently and many fibro patients are also managing other co-occurring diseases at the same time, such as different kinds of arthritis. Many treatment options are available to address fibromyalgia’s various symptoms, so treatment for fibromyalgia should be multifactorial, individualized, and based on what specific issues and symptoms are affecting you most.
“Not everyone gets the same fibromyalgia treatment,” says Dr. Hackshaw. “We figure it out based on the symptoms that are most concerning for that patient.” He adds that doctors aim to use medications that treat multiple symptoms instead of prescribing multiple medications. “The key is that you need to find your ‘magic’ combination that works for you,” says Stackelhouse.
Medications for Fibromyalgia
Various medications can help reduce the pain of fibromyalgia and improve sleep. Common options include.
Anti-seizure drugs
Some medications used to treat epilepsy are often useful in reducing pain and improving sleep in fibromyalgia. These medications prevent sensitive nerves from sending too many pain signals to the brain. Gabapentin (Neurontin) may help lessen pain and fatigue and improve sleep. Pregabalin (Lyrica) was the first drug approved by the Food and Drug Administration to treat fibromyalgia pain, fatigue, and sleep problems. These drugs are thought to relieve pain by blocking certain chemicals that increase pain transmission. Side effects include weight gain, swelling in lower legs, blurred vision, and dizziness.
Antidepressants
Several different classes of drugs that are used to treat depression can also effectively treat fibromyalgia. “These drugs work just as well in fibromyalgia patients who are not depressed as those who are,” says Daniel Clauw, MD, professor of anesthesiology, medicine (rheumatology), and psychiatry at the University of Michigan in Ann Arbor. “They work by changing levels of neurotransmitters, or brain chemicals, that are abnormal in people with fibromyalgia.”
Tricyclic antidepressants
Tricyclic antidepressants (TCAs) are often used first in treating fibromyalgia. Examples include amitriptyline (Elavil), nortriptyline (Pamelor), and cyclobenzaprine (Flexeril). Taking TCAs before you go to sleep may help alleviate muscle pain and promote deeper sleep. While doses used in fibromyalgia are lower than in depression, side effects are still common. They can include fluid retention, weight gain, drowsiness, constipation, dry mouth, and difficulty concentrating.
Serotonin-norepinephrine reuptake inhibitors (SNRIs)
SNRIs can help particularly with fibromyalgia-related cognitive issues as well as well as pain, fatigue, anxiety, depression, and sleep problems. You may be prescribed duloxetine (Cymbalta) or milnacipran (Savella). Side effects include nausea, dizziness, dry mouth, headache, and sweating.
Selective serotine-reuptake inhibitors (SSRIs)
SSRIs may help with fibromyalgia-related cognitive issues as well as pain and depression. They increase the concentration of serotonin, a brain chemical that regulates the delivery of messages between nerve cells. You may be prescribed fluoxetine (Prozac) or paroxetine (Paxil, Pexeva). Side effects include nausea, vomiting, diarrhea, drowsiness, dry mouth, and effects on sexual desire and appetite.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Over-the-counter medications like ibuprofen (Advil) and naproxen (Alleve) may help relieve some fibro pain. “They may help relieve some of the pain of fibromyalgia, but in general these drugs do not help this type of pain as much as pain from other conditions [like arthritis],” says Dr. Clauw, who serves as director of the University of Michigan’s Chronic Pain and Fatigue Research Center. Even though many NSAIDs are available over the counter, they can have side effects such as stomach ulcers and kidney dysfunction.
Exercise for Fibromyalgia
Aerobic exercise
Exercise may be the last thing you want to do when you’re battling the fatigue, pain, and depression that come along with fibro, but many people find that once they begin exercising, it helps ease their fibromyalgia symptoms. Experiment to find the exercise routine that works best for you. You don’t need to spend hours in the gym to have an impact. Even walking for 10 minutes is a good start. Gentle, low-impact activity like walking, cycling, and swimming can help reduce muscle pain and improve muscle strength. A review that analyzed previous studies of aerobic exercise to treat fibromyalgia found that aerobic exercise can improve quality of life, stiffness and pain, and may improve muscle function.
Strength training
Strength training, which can include classes at a local gym or lifting weights at home, may help strengthen muscles and improve fibro symptoms. A study of women with fibromyalgia found that progressive resistance training was linked to greater overall health, pain relief, and muscle strength.
Tai chi
Some people with fibromyalgia may benefit from tai chi, a traditional Chinese exercise that combines mind-body practice with gentle, flowing movement exercises. Since tai chi promotes mind-body awareness, it may help with fibromyalgia’s physical and emotional symptoms. A study found that yang-style supervised tai chi could be as effective or more effective than aerobic exercise for managing fibromyalgia symptoms. Study participants got the most relief when they attended tai chi classes regularly. People who attended two classes a week for 24 weeks had the most significant symptom improvements.
Yoga
In yoga, you engage in gentle stretching and work on mind-body awareness. A study found that yoga may help with fibromyalgia symptoms including perceived disability, depression, and fear of movement. This study suggests that yoga might also serve as a bridge to other forms of exercise, such as aerobic exercise, for people whose fibro symptoms prevent them from doing higher-intensity exercise.
Regardless of what kind of exercise you do, it’s important to pace yourself and give yourself plenty of rest time between exercise sessions, says Stackelhouse. If you’re walking for exercise, for example, you might walk five to 10 minutes on Monday. Rest on Tuesday and maybe even Wednesday. Then increase your time by a few minutes the next time you walk. “Build that capacity. Start small and go slow,” she says. “I mean really small and slow.”
Diet for Fibromyalgia
There’s no one diet for fibromyalgia, but a healthy, balanced diet that includes combinations of whole grains, protein, and healthy fats at most meals and snacks can help maintain energy and combat fatigue. The components of anti-inflammatory diets like a Mediterranean-style diet work well for fibro patients. This includes eat more fruits, vegetables, legumes, and plant-based foods; getting more omega-3s; and reducing sugar, refined grains, and processed foods. In addition, experts advise keeping a food diary for a short period of time to identify potential food triggers that may make fibro symptoms worse, including dairy, MSG, caffeine, or artificial sweeteners.
