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NRx Pharmaceuticals Reports Minutes of Recent U.S. Food and Drug Administration (FDA) Meeting on the Development of NRX-101 to Treat Severe Bipolar Depression in Patients with Suicidality
FDA discussed a broader indication of "treatment of recently acutely suicidal patients" with Bipolar Depression.This broader indication does not require
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"FDA discussed a broader indication of \"treatment of recently acutely suicidal patients\" with Bipolar Depression.This broader indication does not require ketamine as the only stabilization agent.The Company estimates this substantially increases the addressable acute population for its treatment.FDA encouraged NRX to request a Breakthrough Therapy Planning Meeting for NRX-101.FDA suggested the NRX-101 clinical development program be enlarged to allow for chronic treatment of patients with Bipolar Depression and intermittent suicidality.This expanded development program could enable the use of NRX-101 by a broader segment of the approximately 7 million individuals in the U.S. with Bipolar Disorder on a long-term basis.The Company is considering expanding its current phase 2 clinical trial to a potential registration study based on the FDA current guidance using newly released commercial-scale NRX-101 product.FDA deemed the Company's remaining nonclinical development plan to be reasonable and indicated that deferring Pediatric and Adolescent trials until after drug approval appears reasonable.RADNOR, Pa., Feb. 13, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (\"NRx Pharmaceuticals\", the \"Company\"), a clinical-stage biopharmaceutical company, today reported the minutes of a Type B meeting with the U.S. Food and Drug Administration's Division of Psychiatry Products held on January 11, 2023.\n\n \n \n \n \n \n \n\n \nNRx Pharma Announces FDA Guidance from January 11, 2023, Type B MeetingThe purpose of the meeting was to discuss requirements for submission of a New Drug Application for NRX-101. FDA noted in written correspondence that the Special Protocol Agreement (SPA), granted in April 2019 remains in effect. Additionally, the FDA suggested during the meeting that a broadening of the addressable population of the indication (under the SPA 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. This broader indication would enable the Company to potentially demonstrate 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 indication is not expect...