NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, said it amended its Investigational New Drug filing for NRX-101 to include use of the drug in combination with Transcranial Magnetic Stimulation for depression, including suicidal depression. The update follows evidence suggesting NRX-101 may significantly enhance TMS outcomes, with published studies showing more than two-fold improvements in symptom reduction and clinical response rates exceeding 80%. The Company noted NRX-101’s D-cycloserine component appears to augment neuroplasticity associated with TMS, while its low-dose lurasidone is intended to mitigate D-cycloserine’s known risk of low-grade hallucinations. NRx said it aims to validate the findings in a well-controlled trial of about 120 participants and is in partnership discussions with TMS device manufacturers to pursue joint registration studies and potential label augmentation.
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About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal Ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has recently filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 (IV ketamine) with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal depression.
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