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Title: FDA Approves Desvenlafaxine for Treatment of Adults With Major Depressive Disorder

"FDA Approves Desvenlafaxine for Treatment of Adults With Major Depressive Disorder"

NEW YORK -- March 3, 2008 --The US Food and Drug Administration (FDA) has approved desvenlafaxine (Pristiq), a structurally novel, once-daily serotonin-norepinephrine reuptake inhibitor, to treat adults with major depressive disorder (MDD). Desvenlafaxine was approved as a once-daily 50-mg dose that does not require titration, which allows physicians to start patients at the recommended therapeutic dose. It was not approved for paediatric patients. The effectiveness of desvenlafaxine was established in four 8-week, randomised, double-blind, placebo-controlled, fixed-dose studies in adult outpatients who met the [Diagnostic and Statistical Manual of Mental Disorders criteria for MDD. Criteria include 5 or more of the following symptoms lasting for 2 weeks or more (at least one must be "depressed mood" or "loss of interest or pleasure"): depressed mood; loss of interest or pleasure; changes in appetite or weight; changes in sleeping patterns; psychomotor agitation or retardation; fatigue or low energy; feeling worthless or guilty for no reason; difficulty thinking or concentrating; or thoughts of death or suicide. Those with MDD also may experience clinically significant distress or impairment in social, occupational, or other important areas of functioning.

At the recommended 50-mg dose, discontinuation was similar among the groups: 4.1% of patients discontinued desvenlafaxine due to an adverse event compared with 3.8% of patients assigned to placebo.

The most common adverse reactions in patients taking desvenlafaxine in short-term, fixed-dose studies (incidence >5% and at least twice the rate of placebo in those assigned to receive 50 or 100 mg) were nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders.

FDA approval was subject to several post-marketing commitments, including conducting and submitting data from a new, long-term maintenance (relapse prevention) study, a sexual dysfunction study, paediatric studies, and a study exploring lower doses. The agency also requested an additional nonclinical toxicity study.

SOURCE: Wyeth Pharmaceuticals

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