The drug will be marketed by Bristol-Myers Squibb who obtained exclusive US distribution rights to Emsam in an agreement with Somerset made in December 2004. Emsam is the first transdermal patch for the treatment of major depressive disorder to be given regulatory approval.
The efficacy of Emsam in relieving depressive symptoms was established in two double-blind, placebo-controlled studies of six and eight week durations that included adult outpatients ages 18 to 70 years old with single and recurrent episodes of major depressive disorder (MDD).
Emsam is a monoamine oxidase inhibitor (MAOI) that has been shown to relieve depressive symptoms in patients with MDD. Although their mechanisms of action are not fully understood, MAOIs, including Emsam, are presumed to work through potentiation of monoamine neurotransmitter activity in the brain by inhibiting the MAO enzyme.
“We are pleased to be able to provide this important treatment to people with major depressive disorder,” said Peter Dolan, CEO, Bristol-Myers Squibb. “We believe Emsam will help physicians treat their patients living with this illness through a new and unique delivery system.”