FDA Nod for Nymalize Nimodipine Oral Solution in SAH

Susan Jeffrey

May 14, 2013

The US Food and Drug Administration (FDA) has approved a new oral nimodipine solution (Nymalize, Arbor Pharmaceuticals Inc) for the treatment of patients with subarachnoid hemorrhage (SAH). Nimodipine had been available only as a liquid-filled gel capsule, the FDA said in a statement released today.

The FDA had received reports of serious and sometimes fatal consequences from intravenous (IV) injection of the liquid contents of oral nimodipine capsules, the statement notes. "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 the IV administration of nimodipine from oral capsules and in 2006 a Boxed Warning was added to the drug to warn against this practice.

"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," Russell Katz, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in the statement. "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 to decrease or eliminate medication errors, the application received fast track designation and priority review.

Approval was based on clinical studies evaluating the use of nimodipine oral capsules in patients with SAH, the statement adds. The most common adverse event observed in the studies was decreased blood pressure, so blood pressure should be carefully monitored during treatment.


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