WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) expanded its development plan for NRX-101, amending its Investigational New Drug application to study the drug in combination with Transcranial Magnetic Stimulation for major depression, including suicidal depression. The move positions NRX-101 for a potentially faster path to market as evidence mounts that low-dose D-cycloserine can significantly amplify the therapeutic effects of TMS.
The company said the amended protocol will be available both through clinical trials and under its Expanded Access program. NRx currently has more than 25,000 investigational doses manufactured and ready for use.
NRX-101 pairs D-cycloserine with a low dose of lurasidone. While D-cycloserine has shown antidepressant and neuroplasticity-enhancing effects, the compound alone carries a known potential for mild hallucinations, leading to a longstanding contraindication in depressed patients. The addition of lurasidone — an approved depression therapy with anti-hallucinatory properties — addresses that safety limitation, forming the basis for NRX-101’s patented combination.
Interest in pairing D-cycloserine with TMS has surged following studies suggesting enhanced outcomes. One randomized trial cited by the company reported that patients receiving D-cycloserine alongside standard TMS achieved more than twice the improvement of those receiving placebo. Response rates reached 75 percent, with remission in 40 percent of participants.
Additional real-world findings presented last month showed even stronger results using a modern theta-burst TMS protocol combined with a single oral dose of D-cycloserine. Investigators reported an 87 percent response rate and 72 percent remission at six weeks, measured on the Hamilton Depression Rating Scale.
NRx said the neuroplasticity effects observed in nonclinical research — including dendritic sprouting in brain regions linked to mood regulation — help explain the amplified response seen when D-cycloserine is paired with TMS. If confirmed in a registration-quality trial, the company believes the combination could become standard of care for patients undergoing TMS.
The company estimates that a pivotal study involving roughly 120 participants could be sufficient to support registration. Discussions are underway with manufacturers of FDA-cleared TMS devices to design a joint clinical trial that could support both drug approval and labeling expansion for TMS systems. Because TMS is already reimbursed and widely used, NRx anticipates the study could be completed at relatively low cost.
More than one million Americans may receive TMS annually by 2030, NRx said, creating a sizable new potential market for NRX-101 — one not originally factored into the company’s development plans.
As required for drugs with Breakthrough Therapy designation, NRx has published an Expanded Access policy. Physicians interested in NRX-101 for patients undergoing TMS can contact the company for further details.
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