ROCKVILLE, Md., March 1 - The FDA has approved Emsam (selegiline) as a once-a-day transdermal antidepressant that delivers a monoamine oxidase inhibitor.
When used at 6 mg over 24 hours, its lowest strength, the Emsam patch does not carry the dietary restrictions that are necessary when using oral MAO inhibitors.
When combined with certain foods or drinks -- red wines, lunch meats, cheese, fava beans, Italian green beans are all on the restricted list -- oral MAO inhibitors can trigger sudden spikes in blood pressure causing a hypertensive crisis.
The Emsam patch will be marketed in doses of 6, 9, and 12 mg delivered transdermally over 24 hours. It is a three-layer matrix consisting of a backing, and adhesive drug layer, and a release liner that is placed against the skin.
In clinical studies the patch demonstrated safety and efficacy for treatment of major depressive disorder in two six- to eight-week week studies and also in a longer-term study of patients.
Although study data indicates that the 6 mg dose can be used without dietary restrictions, only limited data is available on food interactions at 9-mg or 12-mg doses, necessitating dietary restrictions recommendations at those doses said the FDA.
The most common side effect of Emsam detected in placebo-controlled trials was a mild skin reaction where the patch was placed. Light-headedness related to hypotension was also reported in a small number of patients.
Direct heat may result in an increased amount of drug released into the skin, said the FDA. So patients should avoid exposing the patch to heating pads, electric blankets, heat lamps, saunas, hot tubs, or prolonged sunlight.
There may be mild redness at the site when a patch is removed. If the redness does not disappear within several hours after removing the patch, or if irritation or itching continues, patients were advised to consult a physician.
Like all approved antidepressants, this product carries a warning of increased suicidality in children and adolescents.
Emsam was developed by Somerset Pharmaceuticals, and will be marketed in the U.S. by Bristol-Myers Squibb.