WASHINGTON (dpa-AFX) - Allergan plc (AGN) Wednesday said that topline results from three major studies of rapastinel as a treatment of major depression disorder failed to meet main goals.
The company said, in three acute studies, the rapastinel treatment arms did not differentiate from placebo on the primary and key secondary endpoints. In all three acute studies rapastinel was well tolerated without any signal of psychotomimetic side effects.
The company also noted that the rapastinel relapse prevention study suggests the primary and key secondary endpoints will not be met.
'We are deeply disappointed with these results, and they are a vivid reminder that drug development is extremely challenging, especially in mental health. We are grateful to the patients, their caregivers, and the investigators who supported these clinical studies. We remain committed to the development of new life changing medications to combat the rising global toll of mental illness,' said David Nicholson, Chief Research & Development Officer at Allergan. 'We will evaluate the impact of these data on the ongoing monotherapy MDD program and suicidality in MDD study. We expect to make a decision on these programs during the course of 2019.'
'As the number of deaths from suicide, alcohol and drugs continue to rise, it is clear that we need effective new approaches for mental illness. We thank Allergan for its long-standing commitment and investment in this important, yet difficult area,' said Michael R. Liebowitz MD, Professor of Clinical Psychiatry, Columbia University, Managing Director, The Medical Research Network in New York City.
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