The Food and Drug Administration (FDA) has granted Orphan Drug designation to NP10679 for the treatment of subarachnoid hemorrhage.
NP10679 is an investigational subunit-specific NMDA receptor inhibitor. The Company believes that NP10679 may provide neuroprotection against ischemic injury caused by vasospasm in subarachnoid hemorrhage with fewer negative side effects compared with currently available NMDA inhibitors. The designation is supported by data from phase 1 studies that demonstrated the safety, tolerability and positive pharmacokinetics of NP10679 in healthy volunteers.
“Based on its encouraging profile, we look forward to commencing a phase 2 clinical trial of NP10679 for [subarachnoid hemorrhage] in 2023,” said James McNamara, MD, Executive Chairman of NeurOp.
The FDA’s Orphan Drug designation is granted to medicines intended to treat or prevent rare diseases or disorders that affect fewer than 200,000 individuals.
NeurOp receives FDA Orphan Drug designation for NP10679 for treatment of subarachnoid hemorrhage. News release. NeurOp, Inc. Accessed December 8, 2021. https://www.businesswire.com/news/home/20211208005130/en/NeurOp-Receives-FDA-Orphan-Drug-Designation-for-NP10679-for-Treatment-of-Subarachnoid-Hemorrhage.