NRX-101 is being evaluated as therapeutic for for suicidal treatment-resistant bipolar depression.
NRx Pharmaceuticals said it has achieved “data lock” in its Phase 2b/3 study of NRX-101 for suicidal treatment-resistant bipolar depression.
Data lock, or database lock, is the process of finalizing and securing the trial database after all data has been reviewed, validated and approved by the principal investigator, marking a critical milestone before FDA submission.
NRx said it expects to release top-line data later this month.
With positive data from the study and FDA comment, NRx will become eligible to receive the balance of its first milestone payment – an additional $4 million – from partners Alvogen and Lotus Pharmaceuticals, according to the company.
Alvogen and Lotus Pharmaceuticals then would be responsible for all future development costs in this indication, NRx added.
“NRx retains rights for all other indications, including chronic pain and PTSD,” the company explained in a news release. “NRx is then poised to receive $320 million in further milestones along with mid-teen royalties on net sales.”
NRX-101 is a patented, oral fixed-dose combination of two FDA-approved drugs: D-cycloserine, an NMDA receptor modulator at certain dosage ranges; and Lurasidone, a 5-HT2a receptor antagonist.
The FDA has awarded breakthrough-therapy designation, fast-track designation, a biomarker letter of support and a special protocol agreement to NRX-101 for treatment of suicidal treatment-resistant bipolar depression.
“It is the only oral medication to have demonstrated both reduced symptoms of depression and reduced suicidal ideation in patients with bipolar depression, a lethal disease that claims the lives of one in five who live with it,” NRx said.
The previous STABIL-B trial resulted in the award of breakthrough-therapy designation for the use of NRX-101 following ketamine in hospitalized patients with severe bipolar depression and acute suicidal ideation. The FDA cleared NRx to conduct a Phase 3 trial in this regard under the special protocol agreement.
FDA then suggested that the company explore whether NRX-101 might be applicable to the much larger population of patients with subacute suicidality who are cared for in the outpatient setting on a chronic basis. The purpose of the trial was to determine whether a signal could be detected that would support a much broader indication for NRX-101, the company noted.
Successful data in this regard would expand the potential market for NRX-101 from several hundred thousand patients per year to several million patients per year, according to NRx.
“Patients with active suicidal ideation have been excluded from the clinical trials of all previously known oral antidepressants,” said Dr. Jonathan Javitt, founder, chairman and chief scientist of NRx Pharmaceuticals. “This trial of NRX-101 is the first under an FDA investigational new-drug application to attempt to develop an oral therapy that offers patients with suicidal bipolar depression an alternative to electroconvulsive therapy, which is currently the only FDA-approved therapy for suicidal depression.”
NRx also has announced plans to submit a new-drug application to FDA this quarter for the use of ketamine as a short-term therapy for suicidal bipolar depression.
“We believe this is the first trial to demonstrate that suicidal patients can safely be enrolled and treated within the context of a clinical trial, and this was only possible because of the close monitoring of our study investigators and site personnel,” Javitt said. “We are deeply appreciative of the tremendous work done by our clinical development team, the study sites and, most importantly, the patients who participated in our trial.”
The Phase 2B/3 trial is a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over six weeks. The principal investigator is Professor Andrew Nierenberg of Harvard Massachusetts General Hospital.