Forest and Lundbeck announced positive results for Lexapro study

Forest Laboratories and Lundbeck have announced positive results for their Phase III study of Lexapro in adolescents with major depressive disorder (MDD).

The preliminary top-line results indicated that patients (aged 12 to 17) treated with Lexapro experienced statistically significant improvements in symptoms of depression as measured by the Children’s Depression Rating Scale-Revised (CDRS-R) compared to a placebo.

The CDRS-R is a commonly used measurement scale that covers 17 symptoms areas of depression relevant to adolescents.

Factors assessed include impaired schoolwork, difficulty having fun, social withdrawal, physical complaints and low self-esteem.

The trial also showed that Lexapro was well tolerated with overall premature discontinuation rates (all causes including adverse events) at 19 per cent for patients receiving Lexapro and 15 per cent for patients receiving the placebo.

Lexapro is not currently approved by the US Food and Drug Administration (FDA) for use in paediatric patients.

However, the companies have stated their intentions to file an adolescent depression indication for Lexapro, subject to ongoing communication with the FDA and review of the full study results for the trial.

Earlier this month, Lundbeck initiated Phase I clinical trials for its pharmaceutical candidate Lu AA47070 in the treatment of neurological diseases including Parkinson’s disease.