FDA Clears Antidepression Patch

The Food and Drug Administration on Tuesday approved the first skin-patch delivery system for treating depression.

The product, known as Emsam, was developed by Somerset Pharmaceuticals, a Tampa, Fla., joint venture of generic drugmakers Mylan Laboratories (MYL) and Watson Pharmaceuticals (WPI). Emsam will be marketed by Bristol-Myers Squibb(BMY).

Emsam contains selegiline, which is used in tablet form as a treatment for Parkinson's disease and also, infrequently, as a treatment for depression. Because selegiline can cause many side effects, especially when taken with certain foods, the companies were looking for a safer way to administer the medication.

Selegiline belongs to a class of drugs known as monoamine oxidase inhibitors, or MAOIs, which can cause severe and even fatal spikes in blood pressure if taken with certain foods, including many cheeses, red wine, caviar, sauerkraut and smoked or cured meats.

The problem is caused when MAOI drugs clash with foods containing tyramine, an amino acid found in the body. Tyramine regulates blood pressure, and MAOI drugs thwart the body's ability to break down tyramine. When tyramine levels rise, so does blood pressure. If someone eats tyramine-containing foods, they can experience what doctors call a hypertensive crisis, which can be fatal if not treated immediately.

Emsam has had a bumpy path to regulatory approval. Somerset applied to the FDA in May 2001, but the agency rejected the Emsam application in March 2002. The FDA asked for more safety and clinical data. Somerset resubmitted its application, which the FDA accepted for review in August 2003.

The FDA granted conditional approval in January 2004, pending negotiations about postmarketing safety studies and dietary warnings on the label. In June 2005, Somerset filed responses to questions posed by the FDA. In October, an FDA advisory panel endorsed Emsam, subject to certain restrictions. The FDA was scheduled to act in late November, but said it needed more time.