ST LOUIS (MD Consult) - On February 3, 2010, Labopharm announced that the US Food and Drug Administration (FDA) has approved Oleptro (trazodone hydrochloride) for the treatment of major depressive disorder (MDD) in adults. Oleptro is formulated as an extended-release tablet for once-daily administraton.
Support for the FDA approval of Oleptro was derived from results of a pivotal 8-week, randomized, double-blind, 2-arm, multicenter study of patients with unipolar MDD. The primary efficacy end point of the study was a comparison of the change in the Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to the end of the study in the Oleptro group versus the placebo group. Statistical significance was achieved for the primary end point (P = .012).
The overall discontinuation rate in the study was 25% (21% in the placebo group and 30% in the Oleptro group). In the Oleptro group, 4% of patients discontinued treatment as a result of somnolence or sedation.
The most common adverse reactions associated with Oleptro are dizziness, constipation, blurred vision, and somnolence/sedation. The product label contains a black-box warning about the potential for an increased risk of suicidal thinking and behavior in children, adolescents, and young adults who are receiving antidepressants for major depressive disorder and other psychiatric disorders. Oleptro is not approved for use in pediatric patients.
Labopharm expects Oleptro to be available for prescription in the United States later in the year 2010.
