AZURITY PHARMACEUTICALS, INC. ANNOUNCES FDA APPROVAL OF EPRONTIA™ (topiramate) oral solution

The first and only FDA-approved ready-to-use liquid topiramate

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Nov 08, 2021, 06:00 ET

WOBURN, Mass., Nov. 8, 2021 /PRNewswire/ -- 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 EPRONTIA™ (topiramate) oral solution, 25 mg/mL.

"Our ability to address each patient's needs, with a tailored approach and a proven therapy, is transformative for patients, caregivers, and the healthcare professionals (HCPs) who treat them," said Amit Patel, Chairman and CEO of Azurity Pharmaceuticals. "EPRONTIA's ready-to-use liquid formulation provides HCPs a therapy that addresses an unmet medical need."

Globally, an estimated 65 million people have epilepsy, and 1 billion suffer from migraine. In the United States, 1 in 26 people will develop epilepsy at some point during their lifetime and approximately 39 million people suffer from migraines.^1,2 For HCPs working with patients suffering from serious neurological conditions, such as seizures associated with epilepsy and migraine headaches, EPRONTIA™ provides a ready to use liquid medication for patients, such as those who have trouble swallowing pills. Caregivers also may benefit from the ease of giving the medication.

"I am pleased that there will now be an FDA-approved liquid formulation of topiramate for patients who may require or prefer a liquid formulation," said Michael C. Smith, MD, Director, Rush Epilepsy Center, and Professor, Department of Neurological Sciences, Rush University Medical Center. "Clinical challenges have existed for years for clinicians looking for a high quality, predictable formulation option of topiramate to effectively meet the varied needs of patients and caregivers."

About EPRONTIA™
EPRONTIA™ is the first and only liquid formulation of topiramate to be approved by the U.S. Food and Drug Administration as a monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; an adjunctive therapy for treatment of partial-onset seizures, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older; and, as a preventive treatment of migraine in patients 12 years of age and older.

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. For more information, visit www.azurity.com.

¹www.epilepsy.com
²www.migraineresearchfoundation.org

SOURCE Azurity Pharmaceuticals