Allergan's Vraylar Positive For Bipolar Disease In Phase III

Allergan plc (NYSE:AGN) , along with partner Gedeon Richter, announced positive top-line results from a second pivotal phase III study on its schizophrenia drug Vraylar.

The study evaluated Vraylar (cariprazine) for treatment of adult patients with major depressive episodes associated with bipolar I disorder (bipolar I depression).

Notably, Vraylar is already approved in the United States and the EU for the acute treatment of manic or mixed episodes associated with bipolar I disorder as well as for schizophrenia. Additionally, the FDA approved the drug last month for an expanded use as a maintenance therapy for treatment of schizophrenia.

Shares of Allergan have declined 18.6% this year so far, comparing favorably with the industry’s decrease of 26%.

The phase III (RGH-MD-54) study was investigating two doses of Vraylar (1.5 mg and 3 mg) in a total of 488 patients with bipolar I depression. The study met its primary endpoints and showed a significant improvement in patients compared with placebo. The drug was generally well-tolerated in the study. However, we also note that of the total number of patients, around 5.0% being treated with Vraylar discontinued the trial due to adverse events in comparison to 2.5% treated with placebo.

Based on the above reported data, the company is planning to submit regulatory applications to the FDA in the second half of 2018.

Significantly, Allergan has a licensing agreement with Gideon Richter, a Hungarian multinational pharmaceutical and biotechnology company, to co-develop and market Vraylar in the United States as well as Canada.

Vraylar has performed well in the first nine months of 2017, recording sales of $200.1 million compared with $51.1 million, registered in the same period a year ago. The drug is likely to be a key driver of Allergan’s top line in 2018.

Per National Alliance of Mental Illness, bipolar disorder is one of the most common mental diseases and the third most common cause of hospitalization in the United States for both youth and adults aged between 18 and 44 years. Moreover, 2.6% of adults in the country live with bipolar disorder. Hence, approval of the drug for the expanded indication will provide the company with access to a wider patient population base with bipolar issues.

Other players in the bipolar disorder and schizophrenia treatment market include AstraZeneca plc's (NYSE:AZN) Seroquel XR, Johnson & Johnson's (NYSE:JNJ) Risperdal Consta and Alkermes plc's (NASDAQ:ALKS) Aristada.

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Allergan carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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