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Allergan's Vraylar Meets Endpoints in Bipolar I Phase III

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Allergan plc and Hungary-based partner Gedeon Richter Plc. have announced positive top-line results from the third pivotal study, evaluating the companies’ schizophrenia drug Vraylar (cariprazine) for an expanded indication. Both entities are looking to get Vraylar approved for the treatment of adults with major depressive episodes related to bipolar I disorder.

Notably, Vraylar is already approved in the United States and the EU for the acute therapy of manic or mixed episodes associated with bipolar I disorder as well as for schizophrenia. Additionally, the FDA approved the drug in November 2017 for an expanded use as a maintenance therapy for treatment of schizophrenia.

Shares of Allergan have inched up 0.7% this year so far against the industry’s decrease of 5.9%.

 

The phase III (RGH-MD-53) study was investigating two doses of Vraylar (1.5 mg and 3 mg) in 493 adult patients with major depressive episodes associated with bipolar I disorder (bipolar I depression) compared with placebo. The study met its primary as well as secondary endpoints.

Though Vraylar’s 1.5 mg dosage showed a significantly greater improvement than placebo on the Montgomery Asberg Depression Rating Scale (MADRS) from baseline to week 6, the 3 mg dose failed to reach statistical significance. However, the drug was generally well-tolerated in the trial. We also note that around 5% of the total patients, under Vraylar treatment, discontinued the trial due to adverse events in comparison to 3% treated with placebo.

We remind investors that last December, Allergan and Gedeon produced positive top-line results from the second pivotal phase III (RGH-MD-54) program, examining Vraylar for treatment of bipolar I depression. This study also met its primary endpoint.

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

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.

The schizophrenia drug performed well in 2017, recording sales of $287.8 million compared with $94.3 million in 2016. It 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 frequent 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 are affected with bipolar disorder. Hence, approval of the drug for the expanded indication will provide the company with access to a wider patient population base suffering bipolar issues.

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

 

Zacks Rank

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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