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news.Irish pharmaceutical firm Actavis has received approval from the US Food and Drug Administration (FDA) for a lower therapeutic dose of VIIBRYD (vilazodone HCl) (20mg) designed to treat adults with major depressive disorder (MDD).
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The supplemental new drug application (sNDA) approval for VIIBRYD expands dosing options available to health care providers when using it to treat MDD in adult patients.
The company said that the VIIBRYD 20mg therapeutic dose is now available in pharmacies.
In January 2011, VIIBRYD was approved as the first and only selective serotonin reuptake inhibitor (SSRI) and 5HT1a receptor partial agonist to treat MDD in adults at a dose of 40mg/day.
The approval of the 20mg dose fulfills a post-marketing commitment with the FDA to identify the minimum effective dose of vilazodone.
The FDA approval was based on data from a 10-week, multicenter, double-blind, placebo-controlled and active-comparator, parallel-group, fixed-dose trial, which included 1133 adult patients with MDD.
The trial’s primary efficacy outcome was the mean change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to week 10, while a secondary outcome was the change from baseline to week 10 on the Clinical Global Impressions-Severity scale (CGI-S).
The company is focused on developing, manufacturing and commercializing generic, brand, branded generic, legacy brands and over-the-counter (OTC) pharmaceutical products for patients through its more than 30 manufacturing and distribution facilities located around the world.