Research and Markets: Clinical Data's Vilazodone: How will this novel anti-depressant fare in the minds of regulators, physicians and patients?
Research and Markets (http://www.researchandmarkets.com/research/bvdhmg/clinical_datas) has announced the addition of the "Clinical Data's Vilazodone: How will this novel antidepressant fare in the minds of regulators, physicians and patients?" report to their offering.
Clinical Data's vilazodone is a novel, dual-acting antidepressant with potential benefits over existing SSRIs. Though efficacy was not impressive in phase II, CLDA achieved success in phase III by increasing the dose and modifying other study parameters. Notably, vilazodone succeeded on all five efficacy endpoints in both pivotal trials and demonstrated a safety profile comparable to other recently approved antidepressants, with a lower rate of sexual side effects. Vilazodone is now under FDA review, with a decision expected in January 2011. Will vilazodone make its market debut in 2011? And can it succeed in this lucrative but highly competitive arena, dominated by multi-billion dollar blockbusters and well established generics? This report discusses issues relating to regulatory approval and commercialization, with a critical eye toward unique qualities that distinguish vilazodone from other antidepressants.
Key Topics Covered:
INTRODUCTION AND BACKGROUND
- Clinical picture
- Disease mechanisms
- Current treatment paradigms
- Vilazodone for major depressive disorder
1. Phase III acute efficacy studies
2. Open-label long term safety study
CLINICAL AND REGULATORY DISCUSSION
1. Current antidepressants are effective but flawed
2. Vilazodone's potential advantages
3. Where does it stand with regard to suicidality
4. Overall safety profile
5. Has the minimum effective dose been identified?
6. Is the safety and efficacy evidence sufficient for approval?
1. Antidepressant market overview
2. Antidepressants in development
3. Will vilazodone's potential advantages lead to commercial gains?
4. The market opportunity for vilazodone
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