Food And Drug Administration Accepts Allergan PLC (AGN) Vraylar For Review As A Supplemental Drug

Allergan plc Ordinary Shares (NYSE:AGN) has announced that an application to have new clinical data for Vraylar evaluated has been accepted by the Food and Drug Administration of the United States.

The new clinical data that is set to be evaluated shows evidence that Vraylar may be effective in schizophrenia’s maintenance treatment. This is because there is a high rate of relapse when it comes to schizophrenic patients who are not on any kind of psychotic treatment.

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“Most patients with schizophrenia are at very high risk of relapse in the absence of antipsychotic treatment. Without maintenance treatment, 60–70 percent of patients relapse within one year, and almost 90 percent relapse within two years,” Herbert Meltzer, a psychiatry professor at Northwestern School of Medicine said.

Open-Label Phase

The new data was gathered from a Phase III study that was placebo-controlled, double-blind, randomized and multinational. Participants who were put on Vraylar (cariprazine) took longer to relapse compared to patients who were taking a placebo. In the course of the study, a period of 20 weeks was used as an open-label phase during which participants suffering from schizophrenia received cariprazine in doses of either 3, 6, or 9 grams. The participants who responded positively and who were able to stabilize were then randomly placed on a placebo or cariprazine with the primary endpoint being to observe first symptom relapse.

From the study it was observed that the rate of relapse in participants who were on placebo was double that of the patients who were on cariprazine.

Gedeon Richter

Cariprazine got the approval of the Food and Drug Administration in 2015. In the United States, it is marketed under the Vraylar brand name and is used for the treatment of bipolar disorder as well as schizophrenia in adults. The drug is taken orally and the recommended dosage is usually once a day. Gedeon Richter initially discovered vraylar and also co-developed it. Allergan plc Ordinary Shares (NYSE:AGN) has the license for the drug in both Canada and the United States.

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Note: This article is written by Andy Parker and was originally published at Market Exclusive.