An oral once-daily extended release formulation of topiramate (Trokendi XR) for the treatment of epilepsy has received final approval from the US Food and Drug Administration (FDA), according to an announcement from Supernus Pharmaceuticals Inc.
The specialty pharmaceutical company said the product should be available in pharmacies over the next few weeks. It is indicated for initial monotherapy in patients 10 years of age and older with partial-onset or primary generalized tonic-clonic seizures, adjunctive therapy in patients 6 years of age and older with partial-onset or primary generalized tonic-clonic seizures, and adjunctive therapy in patients 6 years of age and older with seizures associated with Lennox-Gastaut syndrome.
"We are very excited about the approval of Trokendi XR and its upcoming launch," said Jack Khattar, chief executive officer, president and director of Supernus, in a press statement. "This is excellent news for Supernus, its shareholders, and patients with epilepsy. We remain committed to the epilepsy community and very much look forward to now having two products, Trokendi XR and Oxtellar XR, available to patients."
The approval letter states that the FDA has completed its review of the application and that Trokendi XR is approved effective August 16 for use as recommended in the agreed-upon labeling, according to the statement that appears on the Supernus Web site.
The company noted that the product will be available in 25-mg, 50-mg, 100-mg, and 200-mg extended-release capsules.
The FDA granted a waiver for certain pediatric study requirements and a deferral for submission of postmarketing pediatric pharmacokinetic assessments that are due in 2019, followed by clinical assessments in 2025, according to the press release.
Oxtellar XR (extended-release oxcarbazepine) received FDA approval in late 2012 and was introduced in the United States earlier this year. Oxtellar XR is indicated for adjunctive therapy in the treatment of partial seizures in adults and in children aged 6 to 17 years.
Supernus Pharmaceuticals focuses on developing and commercializing products for the treatment of central nervous system (CNS) diseases. In addition to Oxtellar XR and Trokendi XR, the company is developing several product candidates in the field of attention-deficit/hyperactivity disorder.
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Cite this: FDA Approves Extended-Release Once-Daily Epilepsy Drug - Medscape - Aug 21, 2013.