GEPIRONE ER DRUG INFO

IMPORTANT NOTE: Gepirone ER is still in the developement stage. The information below is provided for information purposes only. For more information regarding Gepirone or Fabre Kramer Pharmaceuticals please visit Fabre Kramer Pharmaceuticals.



Fabre Kramer Pharmaceuticals Press Release

Development Status:
NDA Amendment planned for 2007

Phase of Development:
NDA under review at FDA

Clinical Trials
An NDA was submitted in May 2001. The FDA stated that there was one immediate release Gepirone trial in major depression that was positive and one extended release study that was positive. The FDA requested one further short term efficacy trial. There were no serious outstanding issues on CMC or preclinical data.

Fabre-Kramer initiated two 8 week trials of Gepirone extended release in the treatment of major depression. The results of these trials were positive and will form the basis of the amendment to the FDA.

The accumulated safety data for Gepirone is huge. There have been 850 subjects entered in Phase I trials. In Phase II & III, 1900 patients have been treated with Gepirone Immediate Release and 3100 with Gepirone Extended Release. In addition, 634 children and adolescents were enrolled into pediatric trials in depression.

The extensive clinical experience with Gepirone has shown it free of troublesome adverse events. Common adverse events are limited to transient lightheadedness, nausea, and headache. Sexual dysfunction and weight gain, common problems with other antidepressants, are not found with treatment of Gepirone ER. tramadol