FDA approves first patch to treat depression

By Susan Heavey

WASHINGTON (Reuters) – The first skin patch to treat major
depression in adults has won final approval to be sold in the
United States, the U.S. Food and Drug Administration said on
Tuesday.

Patients taking higher doses of the Emsam patch will have
to follow strict dietary guidelines but those taking the lowest
dose will be free to eat cheese, smoked meats and other foods
usually restricted with certain antidepressants.

The patch is made by Somerset Pharmaceuticals Inc., a joint
venture of Mylan Laboratories Inc. and Watson Pharmaceuticals
Inc.. Bristol-Myers Squibb has U.S. marketing rights for the
patch.

Like other monoamine oxidase inhibitors (MAOI), Emsam can
carry the risk of high blood pressure if patients eat those and
other foods containing the compound tyramine.

“The advantage of the patch, nominally, is that it allows
you to take an MAOI, and you can still eat your pizza, too,”
said Dr. Alan Gelenberg, head of the University of Arizona’s
psychiatry department.

The FDA conditionally approved the patch in 2004, provided
the company supplied more data on post-marketing safety.

Some industry analysts and medical experts have low
expectations for sales of the patch, saying a warning on some
doses but not others could be confusing and patients’
sensitivity to the offending food compound varies widely.

Others said the patch offers a needed alternative for
people who can’t take pills but the warnings could discourage
some doctors from prescribing it.

Prudential Equity analysts have projected peak annual
revenue of $50 million or less.

Shares of Mylan closed off 67 cents, or 2.83 percent, at
$23, while Watson fell 38 cents, or 1.25 percent, to $29.98.
Shares of Bristol-Myers ended off 11 cents at $23.10.

All three companies trade on the New York Stock Exchange.

MAOI inhibitors are often used for hard-to-treat patients
with depression, said Gelenberg from the University of Arizona,
and the patch was not likely to be doctors’ first-choice.

Somerset Pharmaceuticals had sought to avoid a label
warning about certain foods for its lowest 6-milligram dose.
The patch will carry the warning in its 9 milligram and 12
milligram doses.

The drug, known generically as selegiline, will also carry
a warning about the increased risk of suicidal behavior that
all antidepressants have had to include since October 2004.

Other side effects with the drug include skin irritation
and lightheadedness linked to lower blood pressure, the FDA
said. The effect of heat on the patch is also not clear.

“Patients should avoid exposing the patch to heating pads,
electric blankets, heat lamps, saunas, hot tubs, or prolonged
sunlight,” the FDA said.

Somerset also sells selegiline as a capsule. Other MAOI
drugs on the market include Pfizer Inc.’s Nardil,
GlaxoSmithKline Plc’s Parnate and Oxford Pharmaceutical
Services Inc.’s Marplan, as well as generic versions.

(Additional reporting by Julie Steenhuysen in Chicago)