Trokendi XR

‘Tentative’ FDA Nod to Trokendi XR for Migraine Prevention

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The US Food and Drug Administration (FDA) has granted tentative approval to expand the label for an extended-release formulation of topiramate (Trokendi XR, Supernus Pharmaceuticals), approved for epilepsy, to include prophylaxis of migraine headache in adults, the company announced.

The approval of the company’s Supplemental New Drug Application (sNDA) is tentative because while the FDA has determined that the drug meets all the required quality, safety, and efficacy standards for approval, it is subject to pediatric exclusivity, which expires March 28, 2017, the company reports in a press release August 22.

Final approval may not be made effective until this exclusivity period has expired, the release notes.

“We will continue to work with the FDA to gain final approval upon the expiration of pediatric exclusivity,” said Jack Khattar, president and chief executive officer of Supernus Pharmaceuticals, in a press release. “We are prepared and ready to launch the migraine indication upon receiving full FDA approval.”

Supernus further announced that the FDA has granted final approval to expand the label for Trokendi XR for monotherapy treatment of partial-onset seizures to include patients 6 years and older, rather than 10 years and older, as well as adults.

In addition to now being indicated for initial monotherapy in patients 6 years and older with partial-onset or primary generalized tonic-clonic seizures, Trokendi XR is also indicated as adjunctive therapy in these patients and in those 6 years of age and older with seizures associated with Lennox-Gastaut syndrome.

The product is available in 25-mg, 50-mg, 100-mg, and 200-mg extended-release capsules.

Another extended-release topiramate (Qudexy, Upsher-Smith) received FDA approval as an initial monotherapy in patients as young as 2 years with partial-onset seizures or primary generalized tonic-clonic seizures in June 2015.
It was previously approved in March 2014 for use as initial monotherapy in patients 10 years of age and older with partial-onset seizures or primary generalized tonic-clonic seizures, and as adjunctive therapy in patients 2 years of age or older with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome.

FDA Approves Extended-Release Once-Daily Epilepsy Drug.

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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.

Source: medscape.com