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 allow for weekly dosingduring the long-term treatment of depression. This 90-mg enteric-coated formulation of fluoxetinewas compared with 20-mg daily fluoxetine and placebo during a 25-week continuation treatment periodin a study of 501 depressed patients who had responded to acute treatment with 20-mg dailyfluoxetine. Both active drug formulations were statistically superior to placebo in maintaining theacute treatment response and prolonging the time to relapse. Patients with high baseline anxiety respondedsimilarly to the 90-mg weekly and 20-mg daily fluoxetine treatments. In addition, the 90-mgweekly fluoxetine dose had a safety profile similar to that of both daily fluoxetine dosing and placebo.The once-weekly fluoxetine formulation provides an effective and tolerable treatment option for patientsrequiring extended depression therapy.