Vanda Pharmaceuticals Inc. VNDA announced encouraging data from a randomized, double-blind, placebo-controlled, long-term maintenance study (relapse prevention study in patients with schizophrenia (REPRIEVE)) on Fanapt evaluating its ability to prevent relapse or possible relapse in schizophrenia patients.
In the REPRIEVE study, patients who remained clinically stable for at least 12 weeks were advanced to the ‘Relapse Prevention’ phase, in which they were randomized 1:1 to either continue on the flexible dose regimen of Fanapt or placebo in a double-blinded way. Meanwhile, 79.6% of the patients in the Fanapt arm remained relapse-free at the end of the Relapse Prevention phase compared to 36.6% of the patients in the placebo arm.
The company conducted a predefined un-blinded interim analysis once 68 relapse or impending relapse events were observed. The primary outcome of the study was time-to-relapse or impending relapse using the interim analysis patient population. Mean time-to-relapse was 139 days for patients treated with Fanapt compared to 71 days for placebo.
The data were presented at the annual meeting of the American Society of Clinical Pharmacology.
We note that Fanapt is already approved for the treatment of schizophrenia in adults. In 2014, Fanapt generated $37.4 million (including net product revenue, royalty and licensing fees). Currently, Vanda Pharma intends to submit a supplemental new drug application for Fanapt in the U.S. in the second half of 2015 to include data from the REPRIEVE study in the package insert of the product.
Vanda Pharma carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include Gilead Sciences Inc. GILD, Acorda Therapeutics, Inc. ACOR and Anacor Pharmaceuticals, Inc. ANAC. While Gilead holds a Zacks Rank #1 (Strong Buy), Acorda and Anacor carry a Zacks Rank #2 (Buy).
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