Posted by ravenstorm on October 22, 2004, at 17:35:12
In reply to Re: EMSAM-the deprenyl patch » jboud24, posted by Kristel on October 22, 2004, at 15:40:07
Spoke to someone at the company recently (as was hoping to get in on a clinical trial). They are just wraping up one of their last trials and are indicating done in three to six months. Now, I don't know if that means final approval in that time frame or on the shelves in that time frame.
They had to do more clinical trials to prove to the FDA that a special diet wasn't necessary. My gut instinct is that if the FDA approves the patch but insists that it be marketed WITH FOOD RESTRICTIONS the company won't even bother to produce it. Just no money in another MAOI with food restrictions. As of August the company had not come to terms with a manufacturer.
poster:ravenstorm
thread:405987
URL: http://www.dr-bob.org/babble/20041018/msgs/406089.html