Low-dose versions of Somerset Pharmaceuticals Inc.’s proposed depression patch Emsam should carry a warning against eating certain foods while using the drug, U.S. regulatory staff said in documents made public Tuesday.
Emsam is a monoamine oxidase inhibitor, or MAOI, a type of antidepressant that already carries strong warnings about the heart risks linked to its use with foods containing the compound tyramine, such as smoked meats and dairy products.
Because Emsam is delivered through the skin and does not need to be ingested, its manufacturer is seeking to avoid the so-called “black box” warning for its lowest proposed dose of 20 milligrams.
On Wednesday, a Food and Drug Administration advisory panel plans to discuss whether Emsam should also have to carry the warning. The agency usually follows the advice of its advisers, but not always.
“I do not advocate approval of the 20mg (milligram) Emsam patch without tyramine restrictions and recommend that the FDA proposed text for labeling this issue remain,” FDA staff reviewer Greg Dubitsky wrote in documents released ahead of the meeting.
Somerset is a joint venture of Mylan Laboratories Inc. and Watson Pharmaceuticals Inc. Bristol-Myers Squibb holds U.S. and Canadian marketing rights for Emsam.
If approved, Emsam would be the first U.S.-approved skin patch to treat depression.
'Wide safety margin'
In separate documents released on Tuesday, the drugmakers said clinical data on more than 2,500 Emsam patients showed the drug was well tolerated without any dietary changes.
One study, in which patients taking the drug were encouraged to eat as much aged cheese as possible found they ”could not eat enough to cause a significant increase in blood pressure,” the documents said.
“The benefit of providing a new MAOI at an effective dose --Emsam 20 mg -- that can safely be taken without dietary modifications ... outweighs the risk of inaccurate labeling that would discourage patients who would benefit from this medication,” the companies said.
“We agree that the 30 and the 40 milligrams should have the dietary modifications, and we don’t dispute that,” Watson Pharmaceuticals spokeswoman Patty Eisenhaur told Reuters on Monday.
FDA’s Dubitsky said people’s sensitivity to tyramine in foods can vary widely and said there is a “need for a wide safety margin.”
Somerset received conditional approval for the drug, known generically as selegiline, last year and sent the FDA additional data in June. A final decision is expected in late November.
Some analysts have set low expectations for the drug, which they expect will only be prescribed for hard-to-treat depression by psychiatrists rather than general physicians.