NRx Pharma Says FDA Grants Permission To Proceed On IND For NRX-101 To Treat Chronic Pain

RTTNews | 689 วันที่ผ่านมา
NRx Pharma Says FDA Grants Permission To Proceed On IND For NRX-101 To Treat Chronic Pain

(RTTNews) - Biopharmaceutical company NRx Pharmaceuticals, Inc. (NRXP) announced Monday that FDA has given the company clearance to proceed with human trials to treat Chronic Pain under the Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA) for the use of NRX-101.

The IND application leverages pioneering research on the use of D-cycloserine (a key ingredient of NRX-101) in the treatment of chronic pain and the recent licensure by NRx of a US Patent for the use of D-cycloserine in the treatment of pain.

The company said it is looking forward to initiate commercial development of NRX-101 to treat chronic pain. It also plans to seek Fast Track Designation, Priority Review, and Breakthrough Therapy Designation for this critical indication.

แท็ก : NRXP
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NRx Pharma Achieves Data-lock In Phase 2b/3 Suicidal Treatment Resistant Bipolar Depression Study

NRx Pharma Achieves Data-lock In Phase 2b/3 Suicidal Treatment Resistant Bipolar Depression Study

Biopharmaceutical company NRx Pharmaceuticals, Inc. (NRXP) announced Monday that it has achieved data-lock in its Phase 2b/3 Suicidal Treatment Resistant Bipolar Depression Study with NRX-101. With data-lock, the complete data set is transferred for independent statistical analysis. The top-line data release is expected in April 2024.
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