FDA approves Arbor Pharmaceuticals' NDA for Nymalize oral solution

Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Nymalize™ (nimodipine) oral solution. Nymalize was previously granted Orphan designation which provides seven years of market exclusivity. Nymalize is the first and only nimodipine oral solution indicated for the improvement of neurological outcome in adult patients with subarachnoid hemorrhage (SAH).

Prior to the approval of Nymalize, nimodipine was only available in gel capsule form. Since the product is commonly administered to patients through a nasogastric tube, healthcare providers would extract the product from the gel capsule with a syringe. This has resulted in accidental administrations of nimodipine intravenously instead of via the intended enteral (oral) syringe. 

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." In this communication they reported twenty-five intravenous nimodipine prescribing or administration errors and that four of the patients who mistakenly received nimodipine intravenously died and five had near-death events. The Institute for Safe Medication Practice reported an additional death due to improper nimodipine administration in February 2013.

Ed Schutter , President & CEO of Arbor stated, "I am pleased that Arbor's first NDA approval has the potential to save lives by reducing the opportunity for hospital administration errors.  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."

Dr. Laurence Downey , VP of Medical & Scientific Affairs added, "Approval of our first NDA is an important milestone in the evolution of Arbor Pharmaceuticals. 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."

Arbor Pharmaceuticals will launch Nymalize in the next few months. 

SOURCE Arbor Pharmaceuticals