The three-month delay will allow the FDA sufficient time to review an amendment to Somerset’s new drug application (NDA) submitted following the recommendations of the FDA’s psychopharmacologic drug advisory committee.
In October 2005, the FDA advisory committee voted that Emsam could be safely administered without tyramine dietary modifications at 20mg. Emsam 30 and 40mg will be administered with tyramine dietary modifications as originally proposed by Somerset.
The committee also agreed that Somerset and Bristol-Myers Squibb could effectively communicate dietary instructions required at the higher doses, without requiring the same dietary instructions for the 20mg dose. However, the FDA is not bound by the committee’s recommendations.
Emsam received an ‘approvable’ letter from the FDA on January 30, 2004 and would be the first transdermal patch for the treatment of major depressive disorder upon final approval. Emsam is an irreversible monoamine oxidase inhibitor that, when applied to the skin, is designed to deliver selegiline continuously over a 24-hour period. In December 2004, Somerset and Bristol- Myers Squibb entered into an agreement for the commercialization and distribution of Emsam.