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FDA Clears Antidepression Patch

The product is made by a joint venture of Mylan and Watson.

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) - Get Viatris, Inc. Report

and

Watson Pharmaceuticals

(WPI)

. Emsam will be marketed by

Bristol-Myers Squibb

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(BMY) - Get Bristol-Myers Squibb Company Report

.

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.

Much of the delay in the FDA's approval focused on negotiations over dietary warnings placed on the label. If the agency had demanded restrictions as tough as those for selegiline pills, Emsam would lose much of its marketing advantage. The companies won a partial victory. The FDA won't impose dietary restrictions at the starting dose of 6 milligrams per 24 hours, but warnings must accompany higher doses of 9 milligrams or 12 milligrams per 24 hours.

Because the Emsam patch enables selegiline to be absorbed into the bloodstream, "initial exposure of the drug to the digestive tract is minimized," Bristol-Myers Squibb said Tuesday. Bristol-Myers Squibb noted that clinical trials didn't test whether higher doses of the drug were more effective than the starting dose. In order to reduce the risk of runaway blood pressure, patients must avoid high-tyramine foods while they take the higher Emsam doses, for two weeks after discontinuing treatment at those doses or while reducing the dose to 6 milligrams a day.

Emsam, which isn't approved for children, has a host of other warnings, including the general one required by the FDA that studies show antidepressants increase the risk of suicidal thinking and behavior in children and adolescents with depression and other psychiatric disorders. Federal law permits "off-label" prescribing of drugs. That means that once the FDA approves a drug for one disease, condition or group, doctors may prescribe it for uses not endorsed by the FDA.

Emsam's label also warns that the drug shouldn't be taken with a host of other antidepressants, certain analgesics and the supplement St. John's wort. Emsam users shouldn't drink alcohol.

Shares of Bristol-Myers Squibb were off 10 cents to $23.11. Mylan fell 82 cents to $22.85, and Watson dropped 36 cents to $30.