Positive mid-stage results for Forest Labs and Gedeon Richter’s cariprazine in MDD

US drugmaker Forest Laboratories (NYSE: FRX) and Gedeon Richter (RICHT: HB), Hungary’s largest pharma company, have released positive top-line results from a Phase IIb trial evaluating the efficacy and safety of the investigational antipsychotic cariprazine as adjunctive treatment in adult patients with major depressive disorder (MDD) who have demonstrated an inadequate response to antidepressant therapy (ADT).

The trial consisted of three treatment groups, cariprazine 1.0 – 2.0mg/day + ADT and cariprazine 2.0 – 4.5mg/day + ADT, and placebo + ADT. The group who received cariprazine 2.0 – 4.5mg/day + ADT demonstrated statistically significant improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) total score versus placebo at 8 weeks, the primary endpoint.

“Forest is committed to addressing the therapeutic needs of people living with MDD as part of our growing mental health portfolio, and we are excited at the prospect to one day offer a new treatment option for appropriate patients seeking an alternative treatment to manage the condition,” said Marco Taglietti, chief medical officer and executive vice president, drug development and research at Forest Laboratories.