NRX Pharmaceuticals(US:NRXP) Globenewswire·2025-12-03 12:00Core Insights - NRx Pharmaceuticals has amended its Investigational New Drug filing for NRX-101 to include its use in conjunction with Transcranial Magnetic Stimulation (TMS) for treating depression, including suicidal depression [1][8] Group 1: Clinical Findings - NRX-101 has shown a promising new indication that may expedite its commercialization as a Breakthrough Therapy-designated drug, with evidence indicating a more than two-fold benefit in symptom reduction when combined with TMS [2] - Clinical trials reported a 75% clinical response and a 40% remission rate in patients treated with D-cycloserine (DCS) alongside TMS [2] - A recent study using a modern TMS device and a one-day protocol combined with DCS showed an 87% clinical response and a 72% remission rate at six weeks [3] Group 2: Mechanism and Efficacy - Nonclinical evidence suggests that D-cycloserine enhances neuroplasticity when used with TMS, potentially leading to a response rate exceeding 80%, which is significantly higher than the 30% success rate associated with traditional SSRI antidepressants [4] - NRX-101 combines D-cycloserine with a low dose of lurasidone, which is already approved for depression treatment and has anti-hallucinatory properties, addressing the contraindication of DCS in depression patients [5] Group 3: Future Prospects - The company plans to conduct well-controlled trials with approximately 120 participants to further validate the clinical benefits observed in earlier studies [6] - NRx anticipates that over 1 million Americans may be treated with TMS annually by 2030, creating a substantial market opportunity for NRX-101 [7] - The company has published an Expanded Access policy for NRX-101, allowing physicians to request information for patients who may benefit from the treatment [7]