On Tuesday, the US Food and Drug Administration (FDA) gave a go-ahead to the first skin patch for curing symptoms of deep depression in adults. The patch, called Emsam, will now be made available in the United States with a black box label about suicidal thoughts in adolescents as also dietary guidelines for those taking high doses.
Medically termed the selegiline transdermal patch, Emsam belongs to a class of drugs that are taken by those suffering from Parkinson's disease. It was developed by Somerset Pharmaceuticals and would be marketed by Bristol-Myers Squib. “We believe Emsam will help physicians treat their patients living with this illness through a new and unique delivery system,” said Peter Dolan, chief executive, Bristol-Myers Squibb.
The drug has dietary advantages over the other more popular antidepressants, which prohibit users from taking certain foods like cheese and some types of meats, among others. Those using Emsam in low doses can take such foods. However, patients taking high doses of the drug, which falls in the monoamine oxidase inhibitors (MAOI) category, would have to abstain from such foods and foods that contain tyramine as they can lead to high blood pressure and even heart strokes in severe conditions. “The advantage of the patch, nominally, is that it allows you to take an MAOI, and you can still eat your pizza, too,” said Dr Alan Gelenberg, a psychiatrist from the University of Arizona.
The drug won FDA approval in 1989 for the patients of Parkinson's disease. It is administered to depressives only after traditional antidepressants like Prozac, Zoloft and Paxil fail to alleviate the symptoms. So even though the patch has the FDA approval it is not likely to be prescribed by psychiatrists as the first choice.
In addition, confusion about the dosage that allows the patient to eat all kinds of foods might lead to its limited use. Emsam's 9 mg and 12 mg doses would come with the food warnings. Somerset Pharma and Bristol-Myers said those on the 6 mg dosage can indulge in all kinds of foods.
According to FDA's Center for Drug Evaluation and Research director Steven Galson, this new development about foods is a 'significant advance' over the other MAOI taken orally.
Another warning that would be included in the packs is about the increased risk of suicidal thoughts and behavior among youngsters – a standard warning with all antidepressants.
How the patch reacts to heat is also not clear and so the FDA has urged patients to avoid hot surfaces while wearing the patch. “Patients should avoid exposing the patch to heating pads, electric blankets, heat lamps, saunas, hot tubs, or prolonged sunlight,” the FDA said. The patches would have to be worn once per day and would hit the shelves by April this year.
