By: DERRICK GINGERY, Internal Medicine News Digital Network
Food and Drug Administration advisory committee members have recommended lamotrigine extended-release tablets as a monotherapy for partial seizures, relying on the knowledge that the immediate-release version of the drug works for the indication.The Peripheral and Central Nervous System Drugs Advisory Committee found that substantial evidence had been submitted to support the recommendation, but not because of the novel clinical trial design GlaxoSmithKline (GSK) utilized for the supplemental indication. It was the fact that the immediate-release (IR) version of the same drug already had been approved for monotherapy that swayed a majority of the committee during its March 10 session.
The committee voted 10 to 2 in favor of the evidence of effectiveness for Lamictal XR (extended release). There was one abstention and one member absent for the vote. All the committee members who voted in favor said knowing the immediate-release version was effective affected their decision.
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