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FDA Approves Nymalize for Use In Certain Brain Hemorrhage Patients

New oral formulation may help reduce potentially fatal medication errors

On May 10, the U.S. Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was available only as a liquid-filled gel capsule.

Subarachnoid hemorrhage is serious, life threatening bleeding that occurs in the subarachnoid space – the area between the brain and the thin tissues that cover the brain. Nimodipine is a medication given in a critical care setting to treat neurologic complications from subarachnoid hemorrhage.

Over the years, the FDA has received reports of serious and sometimes fatal consequences from intravenous (IV) injection of the liquid contents of oral nimodipine capsules. IV administration of nimodipine meant for oral use can result in death, cardiac arrest, severe decreases in blood pressure and other heart-related complications. In August 2010, the agency reminded health care professionals about the risks of IV administration of nimodipine from oral capsules and in 2006 a Boxed Warning was added to the drug to warn against such use.

"Having an oral version of this product may help reduce the medication errors we've seen from erroneous intravenous administration of the contents of oral capsules," said Russell Katz, M.D., director of the pision of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Nymalize is a liquid that is administered orally, or via nasogastric tube or gastric tube, and there is no need for a needle to be used, which is what caused past medication errors."

Based on the potential of the oral formulation, Nymalize, to decrease or eliminate medication errors, the application received fast track designation and priority review. Fast track and priority review are two programs the FDA uses to make drugs rapidly available.

The approval of Nymalize is based on clinical studies evaluating the use of nimodipine oral capsules in patients with subarachnoid hemorrhage. The most common adverse event observed in the studies was decreased blood pressure. A patient's blood pressure should be carefully monitored during treatment.

Nymalize is made by Atlanta-based Arbor Pharmaceuticals Inc.

SOURCE:

FDA

May 16, 2013



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