Curated News
By: NewsRamp Editorial Staff
December 03, 2025

NRx Pharma Amends NRX-101 Filing to Combine with TMS for Depression

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TLDR

  • NRx Pharmaceuticals amended its IND for NRX-101 to combine with TMS, potentially offering a competitive edge in depression treatment with over 80% clinical response rates.
  • NRX-101 combines D-cycloserine to enhance TMS-induced neuroplasticity and low-dose lurasidone to mitigate hallucination risks, with validation planned in a 120-participant controlled trial.
  • This development could significantly improve depression treatment outcomes, offering hope for better mental health care and reducing suffering for patients with suicidal depression.
  • NRx Pharmaceuticals is exploring how combining a drug with magnetic brain stimulation might more than double symptom reduction in depression treatment.

Impact - Why it Matters

This development matters because it addresses one of psychiatry's most urgent challenges: treatment-resistant depression, particularly when accompanied by suicidal ideation. Current treatments often fall short, leaving patients and families desperate for alternatives. The combination of NRX-101 with TMS represents a novel approach that could significantly improve outcomes for those who haven't responded to conventional therapies. If successful, this could reduce healthcare costs associated with repeated hospitalizations and long-term disability while dramatically improving quality of life for millions suffering from severe depression. The high response rates suggested by preliminary data (exceeding 80%) are particularly noteworthy in a field where many treatments show much lower efficacy. Furthermore, the partnership approach with TMS device manufacturers could accelerate regulatory approval and clinical adoption, potentially bringing this treatment to patients faster than traditional development pathways.

Summary

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has taken a significant step forward in treating severe depression by amending its Investigational New Drug filing for NRX-101. The update now includes using the drug in combination with Transcranial Magnetic Stimulation (TMS) for depression, including suicidal depression. This strategic move follows compelling evidence suggesting NRX-101 may dramatically enhance TMS outcomes, with published studies showing more than two-fold improvements in symptom reduction and clinical response rates exceeding 80%. The company attributes this potential synergy to NRX-101's unique composition: its D-cycloserine component appears to augment the neuroplasticity effects associated with TMS, while its low-dose lurasidone is designed to mitigate D-cycloserine's known risk of causing low-grade hallucinations.

To validate these promising findings, NRx Pharmaceuticals aims to conduct a well-controlled trial involving approximately 120 participants. Furthermore, the company is actively engaged in partnership discussions with TMS device manufacturers to pursue joint registration studies and explore potential label augmentation, signaling a collaborative approach to advancing this treatment paradigm. This development is part of NRx's broader focus on its NMDA platform for central nervous system disorders, which also includes NRX-100 (preservative-free intravenous ketamine) for suicidal depression. Both NRX-100 and NRX-101 have received significant regulatory recognition, with Fast Track and Breakthrough Therapy Designations respectively, highlighting the urgent medical need and potential of these therapies.

The news was disseminated through BioMedWire (“BMW”), a specialized communications platform within the Dynamic Brand Portfolio @ IBN that focuses on biotechnology and life sciences sectors. BioMedWire provides comprehensive distribution services including wire solutions via InvestorWire, editorial syndication to thousands of outlets, and enhanced press release features to ensure maximum impact for companies like NRx Pharmaceuticals. For investors seeking the latest updates, the company maintains a newsroom at https://ibn.fm/NRXP, while the full press release detailing this development can be accessed at https://ibn.fm/LT0dZ. This announcement represents a potentially transformative approach to treating one of psychiatry's most challenging conditions, combining pharmacological and neuromodulation strategies in a novel way that could offer new hope for patients with treatment-resistant and suicidal depression.

Source Statement

This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, NRx Pharma Amends NRX-101 Filing to Combine with TMS for Depression

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