Somerset's Emsam (selegiline), the first transdermal patch to treat depression, is expected to launch in April.

FDA approved the monoamine oxidase inhibitor for the treatment of major depressive disorder in adults Feb. 27.

Emsam will be promoted by the same Bristol-Myers Squibb neuroscience sales force used to detail the firm's atypical antipsychotic Abilify (aripiprazole); Bristol and Somerset, a joint venture between Mylan Laboratories and Watson, entered into a commercialization deal for the selegiline patch in 2004 (¹ Also see "Emsam Deal Marks Bristol's Return To The Antidepressant Market" - Pink Sheet, 23 December, 2004.).

Approval of the once-daily patch was based on efficacy data from two double-blind, placebo-controlled trials of six- and eight-week duration in adult outpatients with single and recurrent episodes of MDD.

The six-week study of the lowest dose (6 mg/24 hours) showed Emsam was significantly more effective than placebo at improving depressive symptoms, as measured by the Hamilton Depression Rating Scale.

An eight-week dose titration study, in which patients began on the 6 mg dose with possible increases to 9 mg or 12 mg doses, also showed significant improvement compared to placebo.

A controlled clinical trial demonstrated the benefit of maintaining patients on Emsam therapy after achieving a responder status for 25 days.

Emsam labeling includes the "black box" warning against the risk of pediatric suicidality made standard for antidepressant drugs in January 2005 (² Also see "FDA Approves Antidepressant "Black Box" Class Labeling" - Pink Sheet, 13 January, 2005.).

Emsam carries the standard MAOI contraindications for several antidepressants and cold products, but does not have a complete prohibition against food containing high amounts of tyramine, including certain wines and cheeses, which can cause hypertensive reactions.

The lowest 6 mg/24 hour dose is exempt from the dietary restriction. FDA had suggested that all doses carry the restriction, but the agency's Psychopharmacologic Drugs Advisory Committee concluded that there did not appear to be a safety signal at that dose (³ Also see "Somerset Low-Dose Emsam Does Not Need Dietary Restrictions, Committee Says" - Pink Sheet, 26 October, 2005.).

The 9 mg/24 hour and 12 mg/24 hour patches carry the dietary restrictions "due to the more limited data available" about these doses, labeling notes.

Somerset originally submitted the NDA for Emsam for acute and maintenance treatment of major depressive disorder in May 2001.

FDA later deemed the application "not approvable" in March 2002 because only one of four key efficacy studies yielded positive results. The agency requested three additional safety studies, including a trial to examine tyramine-containing foods (⁴ Also see "Mylan/Watson Emsam "Approvable"" - Pink Sheet, 2 February, 2004.).

-Mary Bruce

Emsam Antidepressant Patch Approved; April Launch Anticipated

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