Allergan plc announced topline results from three pivotal studies of rapastinel as an adjunctive treatment of Major Depressive Disorder (MDD). In three acute studies (RAP-MD-01,-02,-03), 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. In addition, an interim analysis of the rapastinel relapse prevention study (RAP-MD-04) 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. 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,
said David Nicholson,
Chief Research & Development Officer at Allergan.
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.
These Phase 3 adjunctive MDD trials evaluated the efficacy, safety and tolerability of rapastinel, compared to placebo, both in combination with antidepressant therapy (ADT) in patients with MDD who had a partial response to ADT. In all three pivotal clinical trials rapastinel was well tolerated and demonstrated a safety and tolerability profile similar to placebo.
Patients who completed the acute trials were eligible to enter the relapse prevention trial (RAP-MD-04). An interim analysis of (RAP-MD-04) was conducted of the primary and secondary efficacy endpoints of all randomized patients in the double-blind treatment period. At the time of the analysis, all patients had completed all visits relevant for determining a relapse.