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FDA approval for Lundbeck and Takeda

Anders Gersel Pedersen

The two companies can once again expand the Clinical Trials section of the U.S. label of their antidepressant Trintellix (vortioxetine) as the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application for the medicine.

Trintellix is a prescription medicine approved for the treatment of adults with Major Depressive Disorder (MDD), also known as depression.

An importan unmet need

The U.S. labeling of Trintellix now includes data from a head-to-head clinical study that demonstrates Trintellix is superior to the commonly-used selective serotonin reuptake inhibitor (SSRI) Lexapro (escitalopram) in improving SSRI-induced sexual dysfunction in adults with MDD. In this study, patients with well-treated depression who were experiencing SSRI-induced sexual dysfunction while taking paroxetine, sertraline or citalopram were switched to Trintellix or escitalopram. Switching to Trintellix led to improvement of TESD.

“Sexual dysfunction can be an issue for patients with MDD. We are hopeful that expanding Trintellix’s label to include TESD data can help address an important unmet need,” says Anders Gersel Pedersen, Executive Vice President, Research and Development, Lundbeck.

In the five years since FDA approval on September 30, 2013, more than 845,000 patients have been prescribed Trintellix. Vortioxetine is approved in 82 countries. This is the second time this year FDA has approved a supplemental new drug application for Trintellix to add new data to the Trintellix U.S. labeling.

Photo of Anders Gersel Pedersen: Lundbeck