Azurity Pharmaceuticals gets FDA OK for Eprontia
Azurity Pharmaceuticals, a private specialty pharmaceutical company focused on developing innovative products to meet the unique needs of patients with underserved conditions, has obtained the Food and Drug Administration's blessing for Eprontia (topiramate) oral solution, 25 mg/mL.
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 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.
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"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 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. The company noted that for health care providers 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.
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"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 Smith, director of the 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."