Products

Gepirone ER
Therapeutic Area(s): Major Depression, Anxiety, Sexual Dysfunction, ADHD
Phase of Development: NDA for Depression Non-Approvable

Development Status:
Currently assessing further development options

Clinical Trials
2 Pivotal Trials in Depression of ER formulation.

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.

Plans for further development of Gepirone in therapeutic indications other than depression are in process.

Partners
Developmental opportunities are available