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Charge to the Committee

Charge to the Committee. Given that the effectiveness standard for approval requires substantial evidence from adequate and well controlled trials that must be balanced with safety, what level of risk is acceptable?. Regulatory Questions.

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Charge to the Committee

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  1. Charge to the Committee • Given that the effectiveness standard for approval requires substantial evidence from adequate and well controlled trials that must be balanced with safety, what level of risk is acceptable?

  2. Regulatory Questions 1. Discuss the efficacy of pleconaril for treatment of acute VRI in adults considering: • Phase 3 efficacy results • Phase 2 efficacy results • Probable use • Prescribed based on symptoms with no diagnostic assay • Prescribed to asymptomatic patients to start when symptoms occur • Need to administer with food • Need to initiate <24 hours of symptom onset • Results in smokers

  3. Regulatory Questions 2. Please discuss the safety of pleconaril considering: • CYP3A4 induction • Menstrual disorders in OC users • Potent risk of unplanned pregnancies • Potential interaction with other medications • Palpitations/tachycardia • Apparent PD interaction with theophylline • Occurrence in clinical trials • Overall tolerability profile

  4. Regulatory Questions 3. Do the safety and efficacy profiles of pleconaril support its approval for treatment of VRI in adults?

  5. Regulatory Questions 4. If the safety and efficacy profile support approval, are there any specific issues that should be addressed in labeling? • Subpopulations • Risk communication

  6. Regulatory Questions 5. If the safety and efficacy profile do not support approval, what additional data should be provided?

  7. Regulatory Questions 6. If safety and efficacy have been established, please comment on the applicant’s phase 4 studies and provide suggestions for other types of studies. • Clinical studies • Pharmacologic studies

  8. Regulatory Questions 7. Please discuss any additional suggestions regarding the design of future studies for this indication. Please consider: • Diagnostic criteria • Patient populations • Endpoints • Potential for drug interactions

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