By RTT News,
February 06, 2014, 06:18:00 PM EDT
(RTTNews.com) - Shire plc (SHP.L, SHPG) said Thursday that two pivotal Phase 3 investigational studies evaluating the efficacy and safety of Vyvanse Capsules versus placebo as an adjunctive treatment for major depressive disorder in adults who inadequately responded to antidepressant monotherapy with a SSRI or SNRI did not meet their primary efficacy endpoints.
The safety profile for Vyvanse in the two studies appears to be generally consistent with the known profile established in studies in adults with Attention-Deficit/Hyperactivity Disorder.
Based on the results, Shire said it will no longer pursue the clinical development program.
Vyvanse is a prescription medicine currently only approved for the treatment of ADHD in the United States, Canada, Australia, several European countries and Brazil.
"While this news in major depressive disorder is disappointing for patients and Shire, we will later in the year be filing with the FDA for a new indication for Vyvanse in Binge Eating Disorder in adults, and Vyvanse is an effective and leading treatment for ADHD," said Flemming Ornskov, Shire's Chief Executive Officer.
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