Recently, in a press release, the manufacturer, Azurity Pharmaceuticals, Inc. announced the FDA approval of its product, Eprontia, its ready-to-use oral solution, 25 mg/mL formulation of topiramate.
The approval of Eprontia is the first and only liquid formulation of topiramate to be approved by the FDA as a monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients aged 2 years and older; as an adjunctive therapy for treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients aged 2 years and older; and as a preventive treatment of migraine in patients aged 12 years and older.
In the press release, Amit Patel, chairman and CEO of Azurity Pharmaceuticals, stated, "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. Eprontia's ready-to-use liquid formulation provides HCPs a therapy that addresses an unmet medical need."
Michael C. Smith, MD, director at Rush Epilepsy Center, and professor at the Department of Neurological Sciences, Rush University Medical Center, added, "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. 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."
Azurity Pharmaceuticals, Inc. is a private specialty pharmaceutical company focused on developing innovative products to meet the unique needs of patients with underserved conditions.
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