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Psychopharmacology Drug Advisory Committee (PDAC) Meeting October 25, 2005

Psychopharmacology Drug Advisory Committee (PDAC) Meeting October 25, 2005. Joseph Camardo, MD Senior VP, Global Medical Affairs. Questions We Should Ask Ourselves. What are the strengths & weaknesses of the proposed changes?

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Psychopharmacology Drug Advisory Committee (PDAC) Meeting October 25, 2005

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  1. Psychopharmacology Drug Advisory Committee (PDAC) MeetingOctober 25, 2005 Joseph Camardo, MD Senior VP, Global Medical Affairs

  2. Questions We Should Ask Ourselves • What are the strengths & weaknesses of the proposed changes? • Will the proposed requirements improve the development programs for psychiatry drugs? • Does the current process need to be fixed?

  3. What are the strengths and weaknesses of the proposal? Strengths • Trials will be enriched with populations less likely to relapse Weaknesses • Current treatment guidelines rely on response at 2-3 months • Trials enriched with unrepresentative subsets of patients • The dose, effectiveness, and tolerability may not be established until Phase 3 • Not feasible to start longer term trials until this information is known • May have long term trials that are not informative

  4. Will the proposed requirements improve development of new psychiatric drugs? • Response & remission rates for most psychiatry conditions remain low, even short term • Phase 4 trials demonstrate drugs approved for acute treatment work chronically • Psychiatric practice is empiric: treatment that works is continued • Requirements should link the trial design with the individual psychiatric condition • Is this consistent with the desire for more responsive and rapid clinical development?

  5. Does the current process need to be fixed? • Long-term effectiveness data is a benefit to patients in psychiatry • Long-term safety and tolerability data has been submitted routinely with initial NDAs and sNDAs • This process allows access to acute treatments while we investigate long-term efficacy

  6. Does the current system need to be fixed? • The post-approval process for generating long-term efficacy data generally is working for psychiatry drugs • The current process allows the appropriate dose for long-term trials to be determined • The current process allows access to treatment while defining long-term effectiveness • The proposed new approach may delay patient access but may not provide additional information critical for approval and use

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