FDA gives orphan drug designation to subarachnoid hemorrhage treatment

The FDA has granted orphan drug designation to NeurOp Inc. for an investigational candidate for treating subarachnoid hemorrhage, according to a company press release.

The treatment, NP10679, is a highly selective antagonist for N-methyl-D-aspartate (NMDA) receptors that offers increased potency in acidic conditions. According to the release, these properties will provide neuroprotection against ischemic injury related to vasospasm in subarachnoid hemorrhage, with fewer negative side effects compared with current NMDA inhibitors and other treatments.

“NP10679 demonstrated safety, tolerability and positive pharmacokinetics in our phase 1 studies that make it an attractive candidate for prophylactic treatment following [subarachnoid hemorrhage],” James McNamara, MD, executive chairman of NeurOp, said in the release. “Based on its encouraging profile, we look forward to commencing a phase 2 clinical trial of NP10679 for [subarachnoid hemorrhage] in 2023.”