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Charge to the Committee. Linda M. Katz, M.D., M.P.H. Deputy Director Division of Over-the-Counter Drug Products June 21, 2002. Prilosec Rx (20 mg capsule). Approved indications Treatment of gastric and duodenal ulcer Symptomatic GERD Erosive eosphagitis

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Charge to the committee

Charge to the Committee

Linda M. Katz, M.D., M.P.H.

Deputy Director

Division of Over-the-Counter Drug Products

June 21, 2002


Prilosec rx 20 mg capsule
Prilosec Rx (20 mg capsule)

  • Approved indications

    • Treatment of gastric and duodenal ulcer

    • Symptomatic GERD

    • Erosive eosphagitis

    • Pathologic hypersecretory conditions


Indications for otc use

Antacids & H2 Receptor Antagonists

Relief of heartburn (antacids only)

Prevention of heartburn

Prilosec 1

Prevention of frequent heartburn (>2 episodes per week)

Indications for OTC Use


Issues for decision making process
Issues for Decision-Making Process

  • Benefit-risk

  • Consumer ability to self-diagnose and self-treat

  • Consumers ability to understand labeling instructions including monitoring, follow-up care and treatment

  • Ability to recognize attainment of goal

  • Ability to recognize toxicity


Rx versus otc drug

Rx Drug

Patient

Disease/condition requiring monitoring

Health care practitioner

Prescription required

OTC Drug

Consumer

Symptom relief

No prescription

Rx versus OTC Drug


Actual use and label comprehension issues
Actual Use and Label Comprehension Issues

  • Ability to appropriately self-select

  • Ability to use the correct dosage, for the time specified in the label

  • Ability to identify when to see a physician

  • Ability to identify serious adverse events

  • Ability to avoid interacting drugs


Issues for discussion
Issues for Discussion

  • Has the sponsor identified an appropriate target population?

    • Consider:

      • Symptomatic overlap with GERD

      • <2 episodes of heartburn a week

      • Relative contraindications

      • Recurrence of symptoms (after discontinuation)

      • Chronicity of therapy (i.e., repeat dosing)

      • Management of acute symptoms


Issues for discussion continued
Issues for Discussion (continued)

  • Has the sponsor demonstrated that consumers can adequately self-select to use?

  • Did consumers with recurrence understand how to use the product?

  • Has the sponsor proposed an acceptable duration of therapy for OTC use?


Issues for discussion continued1
Issues for Discussion (continued)

  • Short-term versus chronic intermittent use

    • Concerns about delayed diagnosis of a serious condition

    • Concerns about rebound after discontinuing treatment


Otc marketing
OTC Marketing

  • Has the sponsor provided sufficient information to support the approval of OTC Prilosec 1 for the treatment of frequent heartburn?


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