NRx Pharmaceuticals ( NASDAQ: NRXP ) on Monday reported the minutes of a Type B meeting with the U.S. Food and Drug Administration's (FDA) Division of Psychiatry Products held on Jan. 11 linked to filing of a new drug application (NDA) for NRX-101 for severe bipolar depression.
The FDA suggested that a broadening of the addressable population of the indication (under a Special Protocol Agreement (SPA) granted in April 2019 or otherwise) to patients with severe bipolar depression and recent acute Suicidality regardless of how the initial stabilization was accomplished could represent a more straightforward development program.
NRX-101 is an oral fixed dose combination of D-cycloserine and lurasidone.
This broader indication would enable the company to potentially show the use of NRX-101 to maintain stabilization from suicidality in patients stabilized either with ketamine or with other standard of care therapeutic approaches. This broader use does not require ketamine as the only stabilization agent, according to NRx.
The company said that this broader indication is not expected to delay the acute care trial expected to be completed in 2023.
The FDA, however, noted that if the results of such a study would be driven mainly by patients stabilized with ketamine, a NDA for ketamine would also be required.
The FDA further guided the company to broaden the study of NRX-101 to include chronic/intermittent treatment of patients with Bipolar Depression and suicidality.
The FDA accepted the company's rationale for deferring pediatric and adolescent studies with NRX-101 until after drug approval and advised the company to include this rationale in its regulatory filings.
"We anticipate amending the indication under our SPA to align with the broader stabilized patient population, and we will discuss this issue further with the FDA at our Breakthrough Therapy Planning Meeting," said NRx CEO Stephen Willard.
The company noted that NRX-101 had received the FDA's breakthrough therapy designation to treat severe bipolar depression in patients with ASIB after initial stabilization with ketamine or other effective therapy.
NRx added that it is considering expanding its current phase 2 trial to a potential registration study based on the FDA's guidance using newly released commercial-scale NRX-101 product.
In January, the company had said that it had reached an alignment with the FDA regarding its proposed registration manufacturing plan.
NRXP +0.89% to $1.13 premarket Feb. 13
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NRx says FDA suggests broadening use of bipolar depression disorder drug in trial