Remedy Pharmaceuticals, a privately-held, Phase 3-ready pharmaceutical company focused on bringing life saving hospital-based treatment to people affected by central nervous system (CNS) related edema, announced that the United States Food and Drug Administration (“FDA”) has granted orphan drug designation to its lead drug, CIRARA™, for both the treatment of acute subarachnoid hemorrhage and acute spinal cord injury.
Subarachnoid hemorrhage (SAH) is a life-threatening form of a stroke characterized by increased pressure on the brain due to blood and fluid buildup in the subarachnoid space. It is estimated that up to 30,000 people per year suffer from SAH in the United States. A Phase II pilot study evaluating CIRARA™ as a treatment for SAH patients is planned to begin in the second half of this year.
Spinal cord injury (SCI) is a condition resulting from trauma or damage to the spinal cord leading to loss or impaired function causing reduced mobility or sensation. Approximately 12,000 new cases of SCI occur in the United States each year. Remedy Pharmaceuticals initiated enrollment for a Phase II pilot study of CIRARA™ in SCI patients in the last quarter of 2015.
