FDA Approves Fleqsuvy (baclofen oral suspension) for the Treatment of Spasticity
WOBURN, MA, February 7, 2022 -- Azurity Pharmaceuticals, Inc., a private specialty pharmaceutical company, focused on developing innovative products to meet the unique needs of patients with underserved conditions, today 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.2 Furthermore, dysphagia is commonly experienced, affecting approximately 43% of multiple sclerosis patients3 and 16-30% of patients with spinal cord injuries.4 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,5,6 which can be an important consideration for those suffering from dysphagia.
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.
About Azurity Pharmaceuticals, Inc.
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of patients with underserved conditions. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients.
1. Wallin MT, Culpepper WJ, Campbell JD, et al. The prevalence of MS in the United States: A population-based estimate using health claims data. Neurology. 2019;92(10):e1029-31040. Published online before print February 15, 2019 DOI 10:1212/WNL.0000000000007035
2. McGuire JR. Epidemiology of spasticity in the adult and child. In: Brashear A, Elovic, eds. Spasticity. 2 ed. New York: Demos Medical; 2016: 5-15.
3. Ansari NN, Tarameshlu M, Ghelichi L. Dysphagia in multiple sclerosis patients: diagnostic and evaluation strategies. Degener Neurol Neuromscul Dis. 2020;10:15-29. doi: 10.2147/DNND.S198659
4. Spinal Cord Injury Research Evidence Project (SCIRE). Dysphagia. https://scireproject.com/evidence/rehabilitation-evidence/nutrition-issues-following-spinal-cord-injury/dietary-int-0/#:~:text=The prevalence of dysphagia. Accessed January 24, 2022.
5. FLEQSUVY [package insert]. Wilmington, MA: Azurity Pharmaceuticals, Inc.; 2022.
6. Ozobax [package insert]. Athens, GA: Metacel Pharmaceuticals, LLC; 2019.
Source: Azurity Pharmaceuticals, Inc.
Posted: February 2022