Posted by yldouglas on May 11, 2005, at 20:06:51
In reply to emsam, posted by harry1 on April 11, 2005, at 19:16:41
Quote:
In December 2004, pharmaceutical firms Bristol-Myers Squibb and Somerset Pharmaceuticals announced they had entered into an agreement to distribute and commercialize EMSAM, the first transdermal treatment for major depression. If the FDA permits, the patch will be marketed in 2005 for both acute and long-term depressive disorder. The FDA's EMSAM "approvable" letter of February 2004 indicated that the efficacy data supported granting a product license. Such approval is by no means a foregone conclusion. It is claimed that EMSAM's pharmacokinetic and pharmacodynamic properties promote the inhibition of MAO-A and MAO-B in the CNS while avoiding significant inhibition of intestinal and liver MAO-A enzyme; but labeling discussions will inevitably focus on the prudence of tyramine dietary restrictions.
poster:yldouglas
thread:483018
URL: http://www.dr-bob.org/babble/20050510/msgs/496609.html