FDA Approves Fleqsuvy, a Concentrated Baclofen Oral Suspension, for the Treatment of Spasticity in Patients with Multiple Sclerosis

The oral formulation of the muscle relaxant was also approved as a treatment for spasticity associated with spinal cord injuries.

The FDA has approved Fleqsuvy (baclofen oral suspension) to treat spasticity resulting from multiple sclerosis (MS) and when it is associated with spinal cord injuries or other spinal cord disorders. Fleqsuvy, approved for use in adults, is a gamma-aminobutyric acid (GABA-ergic) agonist that offers relief of flexor spasms and concomitant pain, clonus and muscle rigidity.

Azurity Pharmaceuticals, the developer of Fleqsuvy, is a Massachusetts-based company that focuses on drugs for use in patients with underserved conditions. MS affects close to a million people in the United States, and spasticity is a symptom reported by about two-thirds of those living with MS. Spinal cord injuries can affect movement, strength, sensation, and bodily functions. Depending on the severity of the injury, damage may be temporary or permanent.

Dysphagia is a common complication of both MS and spinal cord injuries, affecting about 43% of MS patients and up to 30% of spinal cord injury patients, respectively.

Fleqsuvy is available as a grape-flavored 25 mg per 5 mL (5 mg/mL) suspension, offering the most concentrated oral liquid baclofen formulation available. Ozobax, another FDA-approved form of oral liquid baclofen, is available as an oral solution in a 5 mg per 5 mL concentration. For patients with dysphagia and other issues with swallowing, a more concentrated product allows for accurate dosing with a minimum volume of liquid to swallow.

“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 Azurity Pharmaceuticals, said in a news release.

The approval of Fleqsuvy was based on a pharmacokinetic study of healthy adults comparing the bioavailability of Fleqsuvy versus baclofen 20 mg tablets under fasting conditions. Study results showed that Fleqsuvy and baclofen tablets have similar bioavailability.

Fleqsuvy is not indicated for the treatment of skeletal muscle spasms that are associated with rheumatic diseases.