FDA Approves Fleqsuvy (baclofen oral suspension) for the Treatment of Spasticity

Azurity Pharmaceuticals, Inc., a private specialty pharmaceutical company, focused on developing innovative products to meet the unique needs of patients with underserved conditions,  announced the U.S. Food and Drug Administration (FDA) approval of Fleqsuvy™ (baclofen oral suspension), 25 mg per 5 mL (5 mg/mL), Concentrated Formulation for the treatment of spasticity from multiple sclerosis (MS) or patients with spinal cord injuries and other spinal cord diseases.

“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,” said Amit Patel, Chairman and CEO of Azurity Pharmaceuticals.

Nearly 1 million people are living with Multiple Sclerosis in the United States.1 Spasticity is a commonly reported symptom for MS, with an estimated prevalence of spasticity of 67%.2 Due to the severity of spasticity resulting from multiple sclerosis or patients with spinal cord injuries and other spinal cord diseases, dosing becomes paramount to providing appropriate relief. Furthermore, dysphagia is commonly experienced, affecting approximately 43% of multiple sclerosis patients3 and 16-30% of patients with spinal cord injuries. 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.

About Fleqsuvy™

Fleqsuvy™ is a grape-flavored oral suspension formulation of baclofen approved by the FDA for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. It may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Fleqsuvy™ contains 25 mg per 5 mL (5 mg/mL) and is supplied in bottles of either 120mL or 300mL. Limitations of Use: Fleqsuvy™ is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.