 Lower-dose depression patch is safe - US FDA panel
Article on yahoo news:
By Susan Heavey
Wed Oct 26, 5:59 PM ET
GAITHERSBURG, Maryland (Reuters) - A lower-dose version of Somerset
Pharmaceuticals Inc.'s proposed Emsam depression patch can be safely
used without a label warning about interactions with certain foods such
as cheese, a U.S. Food and Drug Administration advisory panel said
on Wednesday.
Somerset, a joint venture of Mylan Laboratories Inc. and Watson
Pharmaceuticals Inc., is awaiting final FDA approval for the drug and
is seeking to avoid a dietary warning for its lowest proposed dose of
20 milligrams.
If approved, Emsam would be the first skin patch on the market to treat
depression. The FDA granted conditional
approval last year but wanted more data. A final decision is expected
in late November.
Mylan shares closed up nearly 3 percent. Shares of Watson and
Bristol-Myers Squibb, which holds U.S. and Canadian
marketing rights for Emsam, edged higher.
Emsam is a monoamine oxidase inhibitor, or MAOI, a type of
antidepressant that carries strong warnings about the risk of high
blood pressure if patients eat smoked meats, dairy products and other
foods containing the compound tyramine.
In a 7-4 vote, the panel said the low-dose version of Emsam could be
used safely without the warning.
FDA reviewer Greg Dubitsky told panelists the overall results from the
company's clinical trials showed no real
safety problem, but risks can vary widely between patients and can
change. "Over time a person's tyramine sensitivity is not fixed; it can
vary quite a bit," he said.
Most panelists said Somerset's data was convincing. Others said they
were concerned that a warning would keep patients and doctors from
trying the medication, especially since it offers an alternative for
those who have trouble taking pills.
"It's clear to me this is going to produce far less risk than existing
medications in terms of hypertension reactions," said panel Chairman
and university of Florida psychiatrist Wayne Goodman. He would still
tell his patients about the dietary concerns as a precaution, he added.
Somerset officials said Emsam was safer because it is delivered through
the skin and is not ingested. Data showed its
20 milligram dose did not need the warning, they said, but there was
not enough data to consider waiving a warning for 30- or 40-milligram
versions.
In a second vote, the panelists narrowly decided it would be acceptable
to have a warning on high-dose versions but not the lower dose. One
panelist left early, making the second vote 6-4.
Psychiatrist James McGough of the university of California at Los
Angeles, who voted against having the warning on just some versions,
said it would be ideal for Somerset to get more positive safety data on
higher doses to avoid the warning altogether. But otherwise, "I think
this is really an invitation for lots of confusion," he said.
Regardless of Emsam's ultimate labeling, some analysts have already set
low expectations. Prudential analysts have
projected peak annual revenue of $50 million or less.
Thomas Laughren, head of FDA's psychiatric drugs division, said the
agency would weigh the panel's recommendations, but added "close votes
are difficult to deal with." The agency usually follows its panelists'
advice.
Shares of Mylan closed up 61 cents at $21.60, Watson rose 16 cents to
$35.49, and Bristol-Myers ended up 6 cents at
$21.71, all on the New York Stock Exchange.
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