FDA Approves Nymalize, A New Nimodipine Oral Solution For Hemorrhagic Stroke Patients
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The U.S. Food and Drug Administration (FDA) approved Nymalize, a new nimodipine oral solution, for use in certain brain hemorrhage patients. The new version of the drug received fast-track approval from the agency, based on its potential to eliminate medical errors.
Previously, nimodipine was available only as a liquid-filled gel capsule. The capsules were used to treat patients experiencing symptoms resulting from subarachnoid hemorrhage, a life-threatening condition in which blood fills the space between certain membranes of the brain. A type of stroke, subarachnoid hemorrhage can result from hypertension, head trauma, or an aneurysm.
The gel capsules were sometimes used inappropriately, and over the years the FDA received reports of the liquid contents of the oral nimodipine capsules being injected intravenously. Normally, the gel is administered through a nasogastric tube, requiring the extraction of gel from its capsule via syringe. Sometimes this gel was injected intervenously by mistake.
Intravenous injection of the liquid found in oral nimodipine capsules can result in death, heart attack, severe drop in blood pressure, and other complications affecting the heart, according to the FDA.
A Black Box Warning explaining the dangers of intravenous injection was added to the drug in 2006, the FDA reports.
In 2010, the FDA issued a "drug safety communication" to healthcare professionals titled "Nimodipine Oral Capsules: Medication Errors — IV Administration May Result in Death, Serious Harm." The report included an account of twenty-five intravenous nimodipine presciption or administration errors, including four patients who mistakenly received nimodipine intravenously and died, as well as five who nearly died.
Improper nimodipine administration was responsible for another death in February, 2013, according to The Institute for Safe Medication 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," said Dr. Russell Katz, director of the Division 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."
Nymalize was previously granted Orphan designation, which entails seven years of market exclusivity. Nymalize is made by Atlanta-based Arbor Pharmaceuticals, Inc.
"I am pleased that Arbor's first NDA [New Drug Application] approval has the potential to save lives by reducing the opportunity for hospital administration errors," said Ed Schutter, President & CEO of Arbor. "To further ensure that we minimize the potential for administration error, each Nymalize unit dose cup will be packaged with an oral syringe. Nymalize adds to our growing portfolio of approved prescription products that can improve the lives of our patients."
"Approval of our first NDA is an important milestone in the evolution of Arbor Pharmaceuticals," said Laurence Downey, VP of Medical & Scientific Affairs at Arbor. "This is the first of what we hope will be multiple NDA approvals over the next several years. I would like to thank and congratulate our team that worked on the Nymalize NDA."
The product is scheduled to launch in the next few months.