FDA Approves Fleqsuvy for Treatment of Spasticity Related to Multiple Sclerosis

The agency has also approved the baclofen oral suspension for Azurity Pharmaceuticals to treat individuals with other spinal cord diseases or injuries.

The FDA has approved baclofen oral suspension (Fleqsuvy, Azurity Pharmaceuticals) at the 25-mg-per-5-mL strength for the treatment of individuals with spasticity from multiple sclerosis (MS) or individuals with other spinal cord diseases or injuries.1

"The approval of Fleqsuvy represents our commitment to providing innovative alternative formulations that address individualized patient needs. The clinical profile of Fleqsuvy allows for a tailored and flexible approach to dosing for patients suffering from spasticity, a debilitating symptom that may impact daily functioning," Amit Patel, chairman and CEO of specialty pharmaceutical company Azurity Pharmaceuticals, said in a statement.1

Nearly 1 million individuals have MS in the United States. Spasticity is a commonly reported symptom for MS. Because of the severity of spasticity resulting from MS or patients with other spinal cord diseases or injuries, dosing becomes paramount to providing appropriate relief.1

In addition, dysphagia is commonly experienced with MS. Fleqsuvy provides an option as a baclofen oral liquid medication at an effective dose for patients who have trouble swallowing pills or prefer a liquid formulation. As the most concentrated FDA-approved oral liquid baclofen formulation, Fleqsuvy allows for the lowest volume to be prescribed for patients, which can be an important consideration for those suffering from dysphagia.1

Fleqsuvy is a grape-flavored oral suspension formulation, particularly for the relief of clonus, flexor spasms and concomitant pain, and muscular rigidity. It is available in bottles of either 120 or 300 mL.1

Fleqsuvy is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders, according to the statement.

A spinal cord injury occurs when there is damage to a bundle of cells and nerves that sends and receives signals from the brain and the rest of the body, according to the National Institutes of Health (NIH).2

Spinal cord injuries can result in either permanent or temporary changes in movement, sensation, strength, and bodily functions below the site of injury. The most common causes of spinal cord injuries in the United States are catastrophic falls and motor vehicle accidents.2

Injuries with little or no cell death can result in an almost complete recovery.2

However, injuries that occur higher on the spinal cord are often more serious and can cause paralysis in the body, according to the NHI.2


1. Azurity Pharmaceuticals, INC announces FDA approval of Fleqsuvy (baclofen oral suspension). PR Newswire. News release. February 7, 2022. Accessed February 7, 2022. Email.

2. National Institute of Neurological Disorders and Stroke. Spinal cord injury information page. Updated June 4, 2021. Accessed February 7, 2022. https://www.ninds.nih.gov/Disorders/All-Disorders/Spinal-Cord-Injury-Information-Page