A new patch to treat severe adult depression was recently approved by the Food and Drug Administration, similar to the Nicotine patch and birth-control patch, will allow patients to have more dietary freedom than users of oral depression medications.
Emsam is a first-of-its-kind skin patch that is designed to treat major depressive disorders in adults and allows its medication to be absorbed into the blood stream over a 24-hour period.
The patch — which is placed on the torso, thigh or upper arm — was created collaboratively by Bristol-Myers Squibb Company, Somerset Pharmaceuticals, Mylan Laboratories and Watson Pharmaceuticals.
The new transdermal, or through-the-skin, treatment will be available only to patients over 18 years old, according to Blaine Davis, a spokeswoman for Bristol-Myers Squibb.
Davis said Emsam was approved on Feb. 28 and is expected to be available to “primary care physicians who treat psychotic disorders” sometime in the near future.
According to HealthyPlace.com, monoamine oxidase enzymes, or MAOs, destroy the brain’s neurotransmitters after they transmit messages throughout the brain, but some anti-depressants do not allow MAOs to destroy the neurotransmitters, causing them to accumulate. Depression is linked to having low levels of these MAOs, and without the enzyme’s cleanup activities, a person is more at risk of depression symptoms, according to the website.
According to a Feb. 28 press release from Bristol-Meyers Squibb, most oral treatments pass through the intestines, making digestion difficult for patients. These drugs can potentially cause blood pressure increases that can lead to stroke when combined with tyramine, which helps support blood pressure. Tyramine is found in foods that are aged, dried, fermented, salted, smoked or pickled, and since the tyramine does not get dissolved, people taking oral drugs must observe specific dietary restrictions.
According to the release, one major side effect of typical depression medication is an increase of blood pressure, called a “hypertensive crisis,” which can be life-threatening.
But Melissa Goodhead, a spokeswoman of Somerset Pharmaceuticals, said the companies were able to develop MAO inhibitors that can treat major depression transdermally, bypassing typical side effects of anti-depressant medication. The patch will also allow patients to receive antidepressant drug dosages without the negative side effects on the stomach.
Goodhead did add that the side effects of Emsam include a “very mild application site reaction and some redness.”
The FDA also mandated that the drug packaging to display a warning of the risks of suicide thoughts. Other side effects may include headaches, insomnia, diarrhea, rashes and sexual dysfunctions, according to MedScape.com.
The patch also includes several effects similar to those of Nicotine patches, such as drowsiness, nausea and fatigue.
Critic of the depression patch Michael Otto, a psychology professor at Boston University, said MAO inhibitors in oral drugs “have a very nasty effect” that can be dangerous if ignored.
“MAOs have a dual reputation,” Otto said. “They’re known for having ‘big guns’ but they’re very difficult to tolerate, and there are many restrictions.”
But Otto said Emsam can benefit users and will give patients to eat what they want because patients can eat foods containing tyramide, and called the patch “a nifty new delivery system.”
Otto also stressed there are other methods of treatment patients should consider before opting for the patch. While anti-depressant medication generally works in roughly 50 percent of all patients, they are not as effective in preventing depressive relapses as certain kinds of psychotherapy.
“It’s a nice thing that people have a lot of range with treatments,” Otto said. “People should consider their other choices and should know that they’re not limited to either modality,” he said.