At a glance
- Company
- NRx Pharmaceuticals
- Ticker
- NASDAQ: NRXP
- Announcement
- Regulatory
Key figures
- Reported symptom reduction improvement
- more than two-fold
- Reported clinical response rates
- exceeding 80%
- Planned trial size
- about 120 participants
Products and programs
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.
To view the full press release, visit https://ibn.fm/LT0dZ
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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In brief
NRx Pharmaceuticals says it amended its Investigational New Drug filing to cover NRX-101 used alongside transcranial magnetic stimulation (TMS) for depression, including suicidal depression. The company cites published research reporting symptom reductions more than two times greater and clinical response rates above 80% when NRX-101 is combined with TMS. NRx says the drug’s D-cycloserine component may support neuroplasticity related to TMS, while low-dose lurasidone is intended to address a risk of low-grade hallucinations associated with D-cycloserine. The company plans to assess the findings in a controlled study involving about 120 participants. It also reports discussions with TMS device manufacturers about joint registration studies and possible label changes.
Key takeaways
- NRx amended its IND to include NRX-101 in combination with TMS for depression, including suicidal depression.
- The company cited published studies reporting symptom reductions more than two-fold greater and clinical response rates above 80%.
- NRx aims to test the findings in a controlled study of about 120 participants.
- The company said it is discussing joint studies and potential label augmentation with TMS device manufacturers.
