Low-dose versions of Somerset Pharmaceuticals Inc.’s proposed depression patch Emsam should carry a warning against eating certain foods while using the drug, says US regulatory staff.
Emsam is a monoamine oxidase inhibitor, or MAOI, a type of antidepressant that already carries strong warnings about the heart risks linked to usage with foods containing tyramine, such as smoked meats and dairy products.
Emsam is delivered through the skin and does not need to be ingested, and because of this its manufacturer is seeking to avoid the “black box” warning for its lowest proposed dose of 20 milligrams.
FDA staff reviewer Greg Dubitsky wrote in documents released ahead of a meeting by a FDA advisory panel to discuss whether Emsam should have to carry the warning,
“I do not advocate approval of a the 20mg Emsam patch without tyramine restrictions and recommend that the FDA proposed text for labeling this issue remain.”
If approved, Emsam would be the first US approved skin patch to treat depression.