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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) MeetingOctober 25, 2005 Joseph Camardo, MD Senior VP, Global Medical Affairs
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?
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
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?
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
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