NeuroRx has completed the feasibility enrolment portion of its Phase llb/lll clinical trial of NRX-101 for the treatment of suicidal bipolar depression.
Patients with Montgomery Asberg Depression Rating Scores of 30 or higher and Columbia Suicide Severity Rating Scale scores of four or five, who are considered to be at highest risk of potential suicide, have been enrolled in the trial.
The trial aims to prove the superiority of NRX-101 against standard of care while maintaining remission from depression and suicidal ideation in patients who have Severe Bipolar Depression and Acute Suicidal Ideation and Behavior.
The feasibility phase of the trial seeks to identify whether patients with suicidal bipolar depression can safely be enrolled and monitored during a six-week trial that begins in the hospital setting and transitions to the outpatient setting as soon as the patient is deemed stable by treating physicians.
A total of 12 patients were enrolled under this phase at hospitals in US states Alabama, North Carolina, and Florida, and were treated initially in the hospital with intravenous ketamine or placebo.
The patients who responded to initial treatment were randomised to receive oral NRX-101 or lurasidone alone on an outpatient basis.
So far, the feasibility phase has not observed any drug-related serious adverse events.
The blinded trial plans to include a complete feasibility assessment by the study’s Data Safety and Monitoring Committee before initiating the pivotal Phase llb/lll efficacy study later this year.
Additionally, in April this year, the US Food and Drug Administration (FDA) granted a Special Protocol Agreement (SPA) to NeuroRx to begin a pivotal trial of NRX-101.
In pursuant to the approval, the pivotal phase under the Special Protocol Agreement expects to include 150 patients at ten or more study sites.
Harvard Medical School Psychiatry professor Andrew Nierenberg will lead the trial.