CIRARA by Remedy Pharmaceuticals receives Orphan Drug Status

Release Date: 07-Feb-2017

US Food and Drug Administration (FDA) has announced orphan drug designation for CIRARA, an investigational drug developed by Remedy Pharmaceuticals, a privately owned pharmaceutical company dedicated to develop lifesaving hospital based treatments for the diseases in central nervous system. The drug has been approved for the designation for the treatment of patients with severe cerebral edema in patients with acute ischemic stroke.


CIRARA is a high affinity inhibitor of Sur1-Trpm4 channels up-regulated following ischemia and trauma. Opening of these channels can lead to chronic edema, midline shift, increased intracranial pressure and brain herniation, culminating in permanent disability or death.


FDA's Orphan Drug Designation program provides certain incentives for companies developing therapeutics to treat rare diseases or conditions, defined as those affecting less than 200,000 individuals in the U.S. A drug candidate and its sponsor must meet several key criteria in order to qualify for, and obtain, orphan drug status. Once a drug has received orphan drug designation, the developer qualifies for a range of benefits, including federal grants, tax credits, reduction in certain regulatory fees, and the potential for seven years of market exclusivity for the drug following FDA marketing approval.


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