New treatment for people with Parkinson's

FDA Consumer, July-August, 2004

People with Parkinson's disease now have a new treatment available for episodes of hypomobility, or "off periods" in which the person becomes immobile or unable to perform activities of daily living.

Apokyn (apomorphine) is an injectable drug that must be taken with an anti-nausea drug because Apokyn can cause severe nausea and vomiting. Apokyn must not, however, be taken with one class of very effective anti-nausea drugs, the 5HT3 antagonists (ondansetron and similar drugs), be cause the combination can lead to very low blood pressure and loss of consciousness.

Apokyn was given priority review because injectable apomorphine is the first therapy approved to treat hypomobility episodes at the time they occur. It is a new molecular entity--a medication containing an active substance that has never before been approved for marketing in any form in the United States. Apokyn also was designated as an orphan product--one that treats a rare disease affecting fewer than 200,000 people in the United States. Although an estimated 1.5 million Americans have Parkinson's disease, about 10 percent--or 150,000 people--experience episodes of hypomobility within three to five years of treatment with standard drugs.

Apokyn's labeling also includes specific warnings about low blood pressure, fainting, hallucinations, and excessive sleepiness. Apokyn is manufactured for Bertek Pharmaceuticals Inc. of Research Triangle Park, N.C., by Draxis Pharma Inc. of Kirkland, Quebec.