The drug is indicated for depressive episodes associated with bipolar in adults. It also holds approval for treating manic or mixed episodes in adults.
Vraylar is an oral, once daily, atypical antipsychotic. The efficacy of the drug is believed to be mediated via partial agonist activity at central dopamine D₂ and serotonin 5-HT1A receptors, along with antagonist activity at serotonin 5-HT2A receptors.
Gedeon Richter discovered and co-developed the drug, while Allergan licensed it in the US and Canada.
Allergan chief research and development (R&D) officer David Nicholson said: “We are committed to developing therapies for complex mental health disorders, including Vraylar, which is currently in Phase III clinical trials for the treatment of major depressive disorder.”
The FDA’s approval of the company’s supplemental new drug application (sNDA) is based on data from pivotal trials RGH-MD-53, RGH-MD-54 and RGH-MD-56.
Study results demonstrated greater improvement when treated with Vraylar in the change from baseline to week six on the Montgomery Asberg Depression Rating Scale (MADRS) compared to placebo.
A 1.5mg dose led to a statistically significant improvement in all the three trials. A 3mg Vraylar dose showed statistical significance over placebo in the RGH-MD-54 study.
Common adverse events observed in the studies were nausea, akathisia, restlessness and extrapyramidal symptoms.
Gedeon Richter research director Dr István Greiner said: “This approval is considered a notable achievement in the development process of cariprazine, our flagship product.
“We are pleased that more and more patient groups suffering from psychiatric disorders will get access to cariprazine as a treatment option.”
Vraylar has been assessed in more than 20 trials for patients with a variety of mental health illnesses.