Therapeutic Area: Major Depression
Phase of Development: NDA Review
- First TRULY NOVEL mechanism for MDD in 20+ years
- “Next Generation” targeted treatment
- Addresses major physician and patient complaints about available therapies
–Sexual dysfunction –Weight gain
- Better compliance lowers healthcare burden and costs for payors
- Benefits should justify first line consideration by formularies
- Pricing competitive with other currently available branded antidepressants
- Additional indications and life cycle management strategies
- Peak annual US market sales potential > $3 Billion
2 Pivotal Trials in Depression of EXXUA support NDA approval.
The accumulated safety data for EXXUA is extensive. In Phase II & III, 3100 patients have been treated with EXXUA. In addition, 634 children and adolescents were enrolled into pediatric trials in depression.
The extensive clinical experience with EXXUA 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 with EXXUA.
Partnering opportunities for commercialization are available.