RADNOR, PA —NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, a clinical-stage biopharmaceutical company, recently announced it has made key advances in developing NRX-101 to treat Chronic Pain.
The Company has signed a License Agreement for US Patent 8,653,120 that claims the use of D-cycloserine for the treatment of chronic pain in exchange for a commitment to pay milestones and royalties as development milestones are reached in the field of chronic pain. The patent is supported by extensive nonclinical data and early clinical data that suggest the potential for NMDA antagonist drugs, such as NRX-101 to decrease both chronic pain and neuropathic pain while potentially decreasing craving for opioids. Additional published non-clinical data previously reported demonstrate that NRX-101 is not neurotoxic1 and not addictive.2
NRx has signed an agreement with Dr. Vania Apkarian, Professor of Physiology, Anesthesia, Surgery, and Neuroscience Institute, Northwestern University Feinberg School of Medicine to join the NRx Pharmaceuticals Scientific Advisory Board (SAB). Over his career, Dr. Apkarian has been devoted to unraveling brain mechanisms that underlie acute and chronic pain, and more generally how the brain dynamically processes information that gives rise to perception. This has included important research into the use of D-cycloserine in Chronic Pain.
“We are delighted to welcome Dr. Apkarian to the NRx SAB,” said Jonathan Javitt, Chief Scientist and Founder of NRx Pharmaceuticals. “Adding a scientist of Vania’s caliber will be invaluable to advancing our clinical program in Chronic Pain.”
NRX-101 Indication – Chronic Pain
- In June 2023, the Company announced a focus on chronic pain as the next focus on NRX-101’s development.
- DCS has been shown to modulate the Pain Pathway at each point in the chain: pain transmission
at dorsal horn of the spinal cord, pain perception in the thalamus (“paleo brain”), and pain memory and processing between the paleo brain and the cortex. - In experimental mouse models and clinical studies, NMDA antagonists have demonstrated attenuation of pain and shown potential in reducing opioid craving. Additionally, DCS has demonstrated no potential for addiction, unlike ketamine, NMDA antagonists and opioids.
- Chronic pain is estimated to be a $60 billion industry today with the potential to grow to a $120 billion industry by 2033.
- D-cycloserine was evaluated in a pilot study at Northwestern University, which showed efficacy at the higher dose levels in the study.3 DCS is currently being examined in a confirmatory trial (n>200) in lower back pain at Northwestern University.4 Data are expected shortly.
- Research conducted by NRx Pharmaceuticals demonstrated a 25 μg/ml dose at which d-cycloserine becomes an NMDA antagonist. The 400mg dose presented in the confirmatory trial at Northwestern University is at the lower end of the threshold and suggests that the ability to increase the d-cycloserine dose beyond 400mg, where lurasidone is used to prevent CNS side effects.
1. Jordan W, Sapko MT, Siegel R, Javitt J. NRX-101, a Rapid-Acting Anti-Depressant, Does Not Cause Neurotoxicity Following Ketamine Administration in Preclinical Models. Int J Toxicol. 2023:10915818231176971. 10.1177/10915818231176971
2. Sapko MT, Hanania T, Chang Q, Javitt JC. D-cycloserine is not susceptible to self-administration using an intravenous self-administration model in male ketamine-habituated Sprague-Dawley rats. Pharmacol Biochem Behav. 2023;227-228:173586. 10.1016/j.pbb.2023.173586
3. Schnitzer TJ, Torbey S, Herrmann K, Kaushal G, Yeasted R, Vania Apkarian A. A randomized placebo-controlled pilot study of the efficacy and safety of D-cycloserine in people with chronic back pain. Mol Pain. 2016;12. 10.1177/1744806916678627
4. D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain. https://classic.clinicaltrials.gov/ct2/show/NCT03535688.
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