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NME: Desvenlafaxine (Pristiq), a selective serotonin and norepinephrine reuptake inhibitor was recently approved for the treatment of major depressive disorder.
New molecular entity
Selective serotonin and norepinephrine reuptake inhibitor approved for the treatment of major depressive disorder
Efficacy. The efficacy of desvenlafaxine was assessed in four 8-week, randomized, double-blind, placebo-controlled, fixed-dose trials involving adult patients with major depressive disorder. In the first study, patients were randomized to desvenlafaxine 100, 200, or 400 mg or placebo once daily. In the second study, patients received desvenlafaxine 200 or 400 mg or placebo once daily. In the third and fourth trials, patients received desvenlafaxine 50 or 100 mg or placebo once daily. In all of the trials, desvenlafaxine was associated with greater improvement in the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score compared with placebo. In 3 of the 4 studies, desvenlafaxine was also associated with greater overall improvement, assessed using the Clinical Global Impressions Scale-Improvement (CGI-I), versus placebo.
Safety. Patients treated with desvenlafaxine should be monitored for clinical worsening and suicide risk. The use of desvenlafaxine has been associated with serotonin syndrome. Desvenlafaxine therapy has been associated with elevated blood pressure; therefore, patients with hypertension should have the condition controlled before starting desvenlafaxine treatment, and blood pressure should be monitored during treatment. Desvenlafaxine may increase the risk of bleeding events, elevated cholesterol and triglyceride levels, and interstitial lung disease and eosinophilic pneumonia. Patients treated with desvenlafaxine have experienced narrow-angle glaucoma; patients at risk of angle-closure glaucoma or with elevated intraocular pressure should be monitored during treatment with this agent. Desvenlafaxine should be used cautiously in patients with bipolar disorder, as the agent can activate mania/hypomania, and in patients with cardiovascular/cerebrovascular disease or seizure disorder. The most common adverse events associated with desvenlafaxine include nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders.
Dosing. The recommended dose of desvenlafaxine is 50 mg once daily with or without food. When therapy is discontinued, the dose of desvenlafaxine should be gradually tapered to minimize discontinuation symptoms.