Clinical studies evaluating the safety, efficacy and tolerability of rapastinel as an adjunctive treatment for major depressive disorder (MDD) did not meet primary and key secondary endpoints, according to topline results announced by Allergan.
Rapastinel is an investigational intravenous (IV) formulation of a novel N-methyl-D-asparate (NMDA) receptor partial agonist. In a phase 2 study, the drug was found to produce a rapid (within 1 day) and sustained antidepressant effect.
The 3 pivotal trials (RAP-MD-01, RAP-MD-02, RAP-MD-03) included patients with MDD who had a partial response to antidepressant therapy (ADT); patients were randomized to receive rapastinel once weekly as a bolus IV injection or placebo in combination with an oral ADT.
Findings from the 3 acute studies showed that the raspatinel treatment arms did not differentiate from placebo based on change from baseline on Montgomery-Asberg Depression Rating Scale (MADRS) total score (primary endpoint). In addition, interim analysis from a study evaluating rapastinel for the prevention of relapse in patients with MDD (RAP-MD-04) suggests that the primary and secondary endpoints of this trial will also 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,” 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.”
For more information visit Allergan.com.