Efficacy and safety of weekly treatment with enteric-coated fluoxetine in patients with major depressive disorder

A new formulation of fluoxetine has been developed that is intended to allo w for weekly dosing during the long-term treatment of depression. This 90-m g enteric-coated formulation of fluoxetine was compared with 20-mg daily fl uoxetine and placebo during a 25-week continuation treatment period in a st udy of 501 depressed patients who had responded to acute treatment with 20- mg daily fluoxetine. Both active drug formulations were statistically super ior to placebo in maintaining the acute treatment response and prolonging t he time to relapse. Patients with high baseline anxiety responded similarly to the 90-mg weekly and 20-mg daily fluoxetine treatments. In addition, th e 90-mg weekly fluoxetine dose had a safety profile similar to that of both daily fluoxetine dosing and placebo. The once-weekly fluoxetine formulatio n provides an effective and tolerable treatment option for patients requiri ng extended depression therapy.