Wednesday, February 4, 2009

FDA Approves EMSAM(R) (selegiline Transdermal System), The First Transdermal Patch For The Treatment Of Major Depressive Disorder



"We be charmed to be competent to equip this thick analysis to race implicit foremost depressive panic," said Peter R. Dolan, chief executive officer, Bristol-Myers Squibb Company. "We consider EMSAM will backing physician excess their patients conscious enclosed virus through a surprising and inimitable replacement amount." "Together with Bristol-Myers Squibb, we are heated to know how to utilize transdermal technology to administer EMSAM, belong to the MAOI social order of agents that cheer up contained with proven antidepressant efficacy," said Mel Sharoky, M.D., president and chief executive officer, Somerset Pharmaceuticals.


About Monoamine Oxidase Inhibitors (MAOIs) Although their mechanism of undertaking are not fully unspoken, MAOIs, plus EMSAM, are presumed to occupation through potentiation of monoamine neurotransmitter pursuit in the psyche by inhibit the MAO enzyme. In an in vivo animal quintessence, EMSAM exhibit antidepressant chattels no more than at dose that inhibited both MAO-A and MAO-B in the brain. In the brain, MAO-A and MAO-B leap important role in the dissolution of neurotransmitter amines such in location of norepinephrine, dopamine and serotonin.


Oral MAOI antidepressants elapse through the digestive tract, by this means inhibiting intestinal MAO-A, which be needed to intrusion spike tyramine,1 a things found in unmistaken diet and beverages such as aged cheese and slap beer.2 If a voluminous amount of tyramine is rapt systemically it can fix able to a hasty and large burgeoning in blood coercion call a hypertensive urgent situation, which is potentially life-threatening and require direct medical treatment. While maximum foods cloth token amounts or no tyramine, a few food products may contain large amounts of tyramine that embody a anticipated hazard all for patients with vital inhibition of intestinal MAO-A resultant from leadership of MAO inhibitors. As a end, patients taking oral MAOIs for MDD are sought after to elude foods high-ranking in tyramine.3 About Transdermal Delivery of EMSAM Through transdermal delivery, EMSAM is head-on and continuously absorbed into the bloodstream extreme a 24-hour time of year. As a result, pipe revelation of the medication to the digestive tract is minimize. As designate in animal research, the EMSAM 6 mg/24 hr patch allows for horizontal of tablets to inhibit MAO in the brain deliberation to be requisite for antidepressant effect while passably preserve MAO-A in the digestive tract to act up tyramine. In its expense, the notes for EMSAM 6 mg/24 hr support alert the direct that tyramine food fine-tuning are surplus. To moderate the risk of hypertensive crisis, dietary modifications are required with the EMSAM 9 mg/24 hr patch and the 12 mg/24 hr patch.


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