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Vraylar ineffective as adjunct therapy for treatment-resistant MDD
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Allergan and Gedeon Richter recently released findings that indicated inefficacy of flexible doses of Vraylar as adjunctive treatment for treatment-resistant major depressive disorder.
To assess efficacy of flexible doses of Vraylar (cariprazine, Allergan) as an adjunctive treatment for major depressive disorder among adults who failed to respond to antidepressant monotherapy, researchers conducted the MD-72 trial, a prospective, randomized, double-blind, placebo-controlled parallel-group study. Doses of cariprazine ranged from 1.5 mg to 4.5 mg. The study was conducted at multiple sites within the U.S.
Analysis indicated that flexible doses of cariprazine did not have significant efficacy compared with placebo.
C. David Nicholson
Previous findings from the MD-75 trial indicated flexible doses of cariprazine, ranging from 2 mg to 4 mg, were significantly more effective as an adjunctive treatment to antidepressant therapy in adults with major depressive disorder who failed to respond to monotherapy, compared with placebo.
“We are disappointed with the results of this trial. However, we believe that our plan to move forward with another phase 3 study in adjunctive MDD coupled with our previous positive clinical trial would provide the two studies needed for submission. This is an important next step to further develop the cariprazine program,” C. David Nicholson, PhD, head of brand research and development at Allergan, said in a press release.
Patient enrollment for a phase 3 clinical trial assessing cariprazine for bipolar depression has begun, according to the release. Two parallel studies will be conducted at approximately 85 sites in the U.S. and Europe.