FDA Approves Desvenlafaxine (Pristiq) for Major Depression

By Peggy Peck
MADISON, N.J., March 3 -- The FDA has approved desvenlafaxine (Pristiq), a serotonin-norepinephrine reuptake inhibitor (SNRI) for use in adults for major depressive disorder, according to an announcement by Wyeth.
Desvenlafaxine is a metabolite and follow-on compound of the company's venlafaxine (Effexor), an antidepressant with patent protection expiring this year. The FDA approval came more than a year after it had issued an approvable letter to Wyeth.
The company said the efficacy of the drug as a treatment for depression was established in four eight-week, randomized, placebo-controlled, fixed-dose studies in adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder. At the recommended dose of 50mg, the discontinuation rate because of adverse experiences for desvenlafaxine (4.1%) was similar to the rate for placebo (3.8%).
A meta-analysis of seven randomized trials of desvenlafaxine reported last May at the American Psychiatric Association meeting found that that the drug reduced anxiety (See: APA: Successor to Effexor Effective Against Anxiety in Depression).
Wyeth said the 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, pediatric studies, and a study exploring lower doses. The agency also requested an additional non-clinical toxicity study.
The drug must not be used concomitantly with a monoamine oxidase inhibitor or within 14 days of stopping MAOI therapy and seven days should be allowed after stopping desvenlafaxine and beginning an MAOI.