Your source for the latest industry trends and drug information news.
Volume 7 | Issue 18
September 15, 2025
Contributors:
Chief Authors: Rebecca Waite, PharmD & Christina Ramsay, PharmD
Contributing Authors: Xintian Wu, PharmD/MBA Candidate, and Jessica Lin PharmD/MBA Candidate
On August 15, 2025, the U.S. Food and Drug Administration (FDA) approved Tonmya™ (cyclobenzaprine hydrochloride) sublingual tablets for the treatment of adult patients with fibromyalgia, a chronic condition causing persistent widespread pain, fatigue and difficulty sleeping. The cause of fibromyalgia is not known, however, there may be a genetic link associated with the condition, along with an increased risk for people with a history of multiple injuries or past illness or infection. Fibromyalgia affects approximately 4 million adults in the United States according to the Centers for Disease Control and Prevention (CDC) and is more common in women than men. Tonmya™ is a sublingual (under the tongue) tablet, which is designed to be absorbed more rapidly into the body. Tonmya™ should not be chewed or crushed. Other drugs FDA approved for the treatment of fibromyalgia include Savella® (milnacipran), Cymbalta® (duloxetine) and Lyrica® (pregabalin). Duloxetine and pregabalin are available as generic equivalents. The active ingredient in Tonmya™, cyclobenzaprine, is also available as an immediate-release (Flexeril®) tablet and an extended-release tablet (Amrix®). Both the immediate-release tablet and the extended-release tablet are available as generic equivalents and are FDA approved for the treatment of muscle spasm only but have been prescribed “off-label” (to treat an indication that is not FDA approved) if the benefits of therapy outweigh the risks.
The efficacy of Tonmya™ for the treatment of fibromyalgia was tested in three randomized, double-blind, placebo-controlled clinical trials with 1,474 patients. The primary endpoint in the trials was a reduction in pain intensity scores measured at week 14 and compared to the patient’s starting pain intensity score. In two out of the three of the clinical trials, Tonmya™ achieved a statistically significant reduction of pain intensity scores versus placebo. The most common side effects observed with Tonmya™ during clinical trial were drowsiness, fatigue, mouth pain, numbness/tingling of the mouth, dry mouth and abnormal product taste. Warnings and precautions for use of Tonmya™ include the avoidance of use during pregnancy due to risk of harm to an unborn baby and the increased risk of serotonin syndrome, especially if used in combination with other drugs, such as antidepressants, that raise serotonin levels. Serotonin syndrome is a serious, potentially life-threatening, drug reaction that occurs from high levels of serotonin that build up in the body. Contraindications to Tonmya™ include use in patients also treated with monoamine oxidase inhibitors (MAOIs) or in those with certain heart conditions (like arrhythmias or congestive heart failure) or hyperthyroidism (overactive thyroid).
On August 22, 2025, the FDA issued a safety notification to the public regarding an over-the-counter product called Pain Flex, which is sold online at Amazon and may also be sold in some retail stores. Pain Flex is a dietary supplement marketed for relief of joint pain. Pain Flex is not an FDA-approved medication. Upon analysis of the ingredients in Pain Flex, the FDA found that the product contained hidden ingredients that are not listed on the package labeling. The FDA found dexamethasone and methocarbamol, which are drugs available by prescription only and should not be found in Pain Flex. Dexamethasone is a steroid that may be prescribed by a doctor to reduce inflammation and is used for short time periods only. The risk of adverse effects, including infection, high blood pressure, high blood sugar and weak bones, increases with long-term use of steroids like dexamethasone. Methocarbamol is a muscle relaxant that may be prescribed by a doctor to reduce pain and muscle stiffness. Methocarbamol is generally used for short time periods only and may cause side effects such as drowsiness, dizziness and headache. Methocarbamol may also impact coordination and impair the ability to drive.
Anyone who purchased or is taking Pain Flex should contact their health care provider immediately to determine how to safely stop taking Pain Flex. There may be risks associated with abrupt discontinuation of the product due to the presence of dexamethasone. If dexamethasone is taken for more than a few weeks, there is a risk of withdrawal and adrenal insufficiency if the drug is stopped suddenly. Symptoms of withdrawal may include severe fatigue, weakness, nausea, vomiting, headache, anxiety, and low blood pressure. Over time, when taking dexamethasone, the body slows down or stops producing its own cortisol, which is a hormone produced by the adrenal glands. Tapering off dexamethasone, which means decreasing the drug gradually, gives the body time to restart producing its own cortisol. Healthcare professionals and patients may submit any product safety concerns regarding Pain Flex to the FDA using the FDA’s MedWatch Program online. Over-the-counter dietary supplements, like Pain Flex, are not FDA approved, and the FDA recommends consumers use caution when purchasing these supplements.
On August 15, 2025, the FDA granted accelerated approval to Wegovy® (semaglutide) for the treatment of adult patients with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (excessive scar tissue caused by inflammation and liver cell damage). MASH is a chronic, progressive, liver disease that if left untreated can lead to liver fibrosis and cirrhosis. Liver fibrosis is measured using the following fibrosis scores: F0 (no scarring), F1 (mild scarring), F2 (moderate scarring), F3 (severe scarring) and F4 (severe scarring and advanced liver disease, also called cirrhosis). The precursor to MASH is metabolic dysfunction-associated steatotic liver disease (MASLD), which is a buildup of fat cells in the liver not caused by increased alcohol consumption. Obesity, type 2 diabetes and high cholesterol are risk factors for the development of MASLD, which is estimated to affect 25% of adults in the U.S. There is currently no FDA-approved drug treatment for MASLD, and recommendations for treatment involve lifestyle modifications, including dietary changes and more exercise, to reduce body weight and lower blood sugar. MASH, which is less common but more severe than MASLD, affects 5-6% of adults in the U.S.
The safety and efficacy of Wegovy® for MASH was evaluated in a randomized, double blind, placebo-controlled trial including 800 patients. Patients were randomly assigned Wegovy® or placebo, along with standard of care treatment for comorbid conditions (like high cholesterol and type 2 diabetes) and lifestyle changes (reduced calorie diet and increased exercise). Efficacy of Wegovy® for treatment of MASH was evaluated by a liver biopsy at week 72 to determine if there was resolution of MASH and no further decline in liver fibrosis score, and secondarily, an improvement of one stage or more in the patient’s starting fibrosis score with no worsening of MASH. Results of the trial showed that 63% of participants on Wegovy® had resolution of MASH and no further decline in liver fibrosis score compared to 34% for placebo, and 37% of participants on Wegovy® had at least a one stage improvement in their starting fibrosis score with no worsening of MASH compared to 22% for placebo. The exact mechanism by which Wegovy® works to treat MASH is not known, but it is theorized that a reduction in body weight contributes to reducing inflammation. Common side effects of Wegovy® are gastrointestinal upset, such as nausea, vomiting, diarrhea and stomach pain. Other side effects include headache, dizziness and increased risk of low blood sugar. Wegovy® was granted an accelerated approval for MASH based on the need for medications to manage the medical condition, as there is only one other FDA-approved treatment option, Rezdiffra™ (resmetirom). Further clinical trials that show clinical benefit are required for Wegovy® to be granted full approval for this indication by the FDA. Besides MASH, Wegovy® is also FDA approved for the treatment of obesity and to reduce the risk of major adverse cardiovascular events (MACE) in adults with cardiovascular disease who are overweight or obese.
New Drug: Dawnzera™ (donidalorsen)
Subcutaneous (under the skin) injection approved for the prevention of hereditary angioedema (HAE) attacks in adult and pediatric patients 12 years and older. HAE is a rare genetic disorder in which a patient experiences episodes of severe swelling in areas of the body, including the arms, legs, face, lungs and intestines. [8/21/2025 – Ionis Pharmaceuticals, Inc.]
Tracleer® (bosentan)
Indication: For the treatment of pulmonary hypertension (high blood pressure in the arteries of the lungs).
Dosage Form/Strength: 32mg tablet for oral suspension
Average Wholesale Price (AWP): Generic = $14,460 | Brand = $16,080
