Patients now have more options to treat major depression after federal officials approved the first antidepressant skin patch.
The Food and Drug Administration approved the once-a-day skin patch — expected to be available to consumers in April — that delivers Emsam, a monoamine oxidase inhibitor, through the skin and into the bloodstream at a constant rate.
Greta DeWolf, National Alliance on Mental Illness of Michigan vice president, said the patch offers another option for patients who are resistant to other antidepressants.
"We are grateful and continue to advocate for all treatments to be available to doctors to use for their patients," DeWolf said in an e-mail.
The patch would have more success with patients, many who forget to take their medicine, if it could be changed weekly instead of daily, DeWolf said.
Patches, which deliver medication through the skin, bring a reduction both in side effects and the pill burden, said Kris King, Mylan Technologies Inc. Director of Investor Relations.
Mylan Technologies, Bristol-Myers Squibb Co. and Somerset Pharmaceuticals Inc. manufacture and distribute Emsam.
If a patient has difficulty ingesting pills or takes multiple pills, Emsam will help reduce the reliance on an oral product, King said.
A monoamine oxidase inhibitor, or MAOI, is an antidepressant medication for major depression that's used to stop neurotransmitters from being destroyed in the brain.
Major depression is a common psychiatric condition in the U.S. population, affecting about 9.9 million adults each year, according to the National Institutes of Health. It is the second most common mental health disorder in the U.S., Bristol-Myers Squibb spokesperson Craig Stoltz said.
Major depression symptoms include general emotional withdrawal, restlessness, increased fatigue and feelings of guilt or worthlessness.
"(Depression) affects all of our facets of life," said Ronald D. Fandrick, a clinical psychologist at New Hope Mental Health Center in Lansing. "The depression emotion is like being in a black hole and seeing no way out."
It takes about two to four weeks for an antidepressant to work successfully with a person and the person should be in counseling while taking the antidepressant, Fandrick said.
Since the medicine goes directly into the bloodstream, not through the digestive track, the response to the medicine would be quicker, he said.
Patients using a skin patch antidepressant like Emsam may feel a false sense of overcoming depression because of the body's quicker response to Emsam, Fandrick said.
"All those underlying problems don't go away because you are on an antidepressant," Fandrick said. "The mood is elevated but you still have the day-to-day hassles (to deal with)."
MAOIs usually require strict, specific dietary restrictions that can cause a large increase in blood pressure, or "hypertensive crisis," possibly leading to death.
Emsam can be used without dietary restrictions at its lowest dosage.
The restrictions are one reason doctors shy away from using MAOIs, Fandrick said. It is an older type of antidepressant commonly replaced by newer antidepressants called selective serotonin reuptake inhibitors, or SSRIs.
Effectiveness and dietary restrictions led doctors to replace MAOIs with SSRIs, Fandrick said.
"Marketing it as a patch is a catch," Fandrick said. "They are trying to put a new wrinkle to an old formula."
