FDA Issues Special Protocol Agreement for Severe Bipolar Depression Treatment

The FDA awarded a Special Protocol Agreement (SPA) letter to NeuroRx, a clinical-stage biopharmaceutical company, for NRX-101, the first drug regimen designed to treat patients with severe bipolar depression and acute suicidal ideation and behavior, the company announced. The FDA has agreed to the design of a phase 2b/3 study of NRX-101, a formulation of d-cycloserine and lurasidone, with the primary endpoints being the change from baseline in measurements of depression via the Montgomery—Åsberg Depression Rating Scale (MADRS) and suicidality via the Columbia Suicide Severity Rating Scale (C-SSRS).

Ultimately the goal is to enroll between 140 and 170 patients. If successful, the therapy could have immense implications for patients suffering from depression with suicidal ideation, who face a multitude of treatment challenges.

“I think it’s becoming increasingly apparent that 50 years of serotonergic drugs have benefitted, at most, half of the people that need them,” Jonathan Javitt MD, MPH, the chief executive officer of NeuroRx, told MD Magazine at the American Psychiatric Association's annual meeting in New York City. “Every one of those drugs has a warning on the label that says it may cause suicide—and there’s a good reason for that. Everything you do to raise serotonin in the brain has the potential to cause an [adverse effect] called akathisia. People with bipolar depression, tragically, are even more susceptible.”

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