Called Emsan, the once a day patch works by delivering selegiline, a monoamine oxidase inhibitor or MAOI, through the skin and into the bloodstream.
At its lowest strength, Emsam can be used without the dietary restrictions that are needed for oral MAO inhibitors.
Dr. Steven Galson, Director for the Center for Drug Evaluation and Research, says in an FDA statement: "Emsam provides a significant advance because at least in its lowest dose patients can use the drug without the usual dietary restrictions associated with these types of drugs known as MAO inhibitors."
The FDA says major depressive disorder is a common psychiatric condition in the U.S. population. Symptoms of depression include general emotional dejection, withdrawal and restlessness that interfere with daily functioning.
Other symptoms include loss of interest in usual activities, significant change in weight and/or appetite, insomnia, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
The FDA says MAO inhibitors usually require specific dietary restrictions because when combined with certain foods they can cause a sudden, large increase in blood pressure, or "hypertensive crisis".
The lowest dose of the MAOI patch delivers 6 milligrams of the medication over a 24 hour period, and can be used without dietary restrictions.
The Emsam patch will be made available in three sizes that deliver 6, 9, or 12 mg of selegiline every 24 hours. The patch is a matrix containing three layers consisting of a backing, and adhesive drug layer, and a release liner that is placed against the skin.
