News Break: New Skin Patch for Treating Depression
The FDA has approved EMSAM, a transdermal patch, for the treatment of major depression.
The FDA has approved EMSAM (selegiline), a transdermal patch, for the treatment of major depression. Selegeline is a MAOI originally used to treat Parkinson's. MAOIs belong to an old class of antidepressants, typically used as a last resort. When taken orally, side effects with these meds tend to be onerous, including risk of tyramine reaction and resulting hypertensive crisis, which necessitates severely restricting one's diet.
The patch was developed by Somerset Pharmaceuticals, who partnered with Bristol-Myers Squibb. Because the drug is absorbed through the skin, there is little or no contact with gastric tyramine and interactions with various enzymes. Based on three small studies, the product labeling advises that a modified diet is not required for 6 mg a day of EMSAM. But due to limited data, the labeling advises that those on doses of 9 and 12 mg are required to restrict their diets. If hypertensive crisis occurs, the drug should be discontinued immediately and therapy to lower blood pressure should be instituted immediately.
EMSAM is contraindicated in use with other antidepressants (including St John's wort), other MAOIs, and Tegretol and Trileptal, plus a range of other medicines including cold products and weight-reducing drugs.
The standard suicide warnings found in other antidepressants are repeated in the EMSAM labeling.
The FDA based its approval on two successful clinical trials. Seven percent of the patients in the trials dropped out due to an adverse event (a lower figure than for other antidepressants).
The main side effect was skin irritation where the patch was applied.
Sexual side effects were minimal, but the labeling cautions that no adequate studies to measure this effect have been performed. Patients lost a mean of 1.2 pounds over six to eight weeks.
According to a Bristol-Myers Squibb spokesperson, quoted on CNN: "Our assumption is that psychiatrists are going to be cautious with this product, but when they're dealing with severe or treatment-resistant depression, we believe that they will turn to this option."
The patch is expected to become available at the end of April.
For Bipolar Patients
The labeling warns about the risk of a manic reaction and against using with other antidepressants, and the mood stabilizers Tegretol, and Trileptal. No clinical trials have been conducted on bipolar patients, and the patch is not indicated for treating bipolar disorder.
Psychiatrists sometimes use antidepressants, including MAOIs, 'off-label' to treat bipolar patients in conjunction with mood stabilizers such as lithium or Depakote. Patients are advised to consult their psychiatrists regarding any possible off-label use.