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Prilosec1 ® 20 mg Tablets Rx to OTC Switch

Prilosec1 ® 20 mg Tablets Rx to OTC Switch. Daiva Shetty, M.D. Division of Over-the-Counter Drug Products (HFD-560) Food and Drug Administration. 1. Prilosec1 ® Rx to OTC Switch: Overview. Regulatory History Proposed Label Target Population Actual Use Study #007. 2.

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Prilosec1 ® 20 mg Tablets Rx to OTC Switch

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  1. Prilosec1® 20 mg TabletsRx to OTC Switch Daiva Shetty, M.D. Division of Over-the-Counter Drug Products (HFD-560) Food and Drug Administration 1

  2. Prilosec1® Rx to OTC Switch: Overview • Regulatory History • Proposed Label • Target Population • Actual Use Study #007 2

  3. Differences Between the Original and Resubmission NDA • OriginalResubmitted • Dose 10 mg 20 mg • Target Population > 12 years > 18 years • Anybody with HB HB > 2 x/week • Uses Relief and prevention Prevention of • frequent HB • Duration 10 days 14 days • (intermittent) (continuous) 3

  4. Overview of the Program • Actual Use Study • #007 • Three Label Comprehension Studies • #02255 • #12179 • #17859 • Proposed OTC Labeling • Safety Update 4

  5. Prilosec1® Rx to OTC Switch: Overview • Regulatory History • Proposed Label • Target Population • Actual Use Study #007 5

  6. Proposed Label: Uses • for prevention of the symptoms of frequent heartburn for 24 hours • only for those who suffer heartburn two or more days a week 6

  7. Proposed Label: Directions • Adults 18 years of age or older: • for prevention of frequent heartburn, swallow 1 tablet with a glass of water in the morning • take every day for 14 days • do not continue beyond 14 days unless directed by your doctor. If your frequent heartburn continues or returns, it could be a sign of a more serious condition. 7

  8. Proposed Label: Warning • Heartburn warning. Heartburn can be a sign of a more serious condition.Notify your doctor if you have had heartburn for 3 months or longer without talking to your doctor. 8

  9. Prilosec1® Rx to OTC Switch: Overview • Regulatory History • Proposed Label • Target Population • Actual Use Study #007 9

  10. OTC Issues for Prilosec1® • Are consumers able to: • self-select/de-select • identify risk factors • self-treat • follow label directions for dosing and duration of use • follow label directions when to see their HCP 10

  11. Actual Use Study #007: Study Design • Multi-center • Open-label • All-comers • Minimal inclusion/exclusion criteria • 3-month duration 11

  12. Primary Objective • How consumers use omeprazole in naturalistic OTC conditions following proposed labeling instructions 12

  13. Results: Self-Selection • Participated in a self-selection interview 1,301 • Answer not available 1 • Self-selected product “Not appropriate” 49 • Self-selected product “Appropriate” 1,251 • (Self-Selection Population) • Answer not available 1 • Subject < 18 years of age 3 • Chose not to participate 384 • Chose to participate 863 13

  14. Chose Not to Participate N=384 • Study participation inconvenient 115 • Don’t try new medicine without • MD approval 104 • Happy with current HB medication 32 • Too expensive 19 • Don’t use medication 5 • Other 113 14

  15. Chose to Participate N=863 • Did not meet study criteria 9 • Purchased study medication 854 • Did not return any diaries 92 • Lost to follow-up 82 • Withdrew consent 8 • Adverse event 1 • Investigator decision 1 • Returned one or more diaries 762 15

  16. Returned One or More Diaries N=762 • Returned blank diaries 4 • Returned diaries & used study drug 758 • (Treated population) • Not available for 3-month follow-up 109 • Available for 3-month follow-up 649 16

  17. Subject Disposition: Summary Excluded from Study (N=12) + 17

  18. Demographics • (Self-Selection Population N=1,251) • 59% Females • 16-91 Years of age, mean 48 • 65% Caucasian • 18% Black • 2% Asian • 1.2% American Indian • 9.4% Low Literacy Group 18

  19. Heartburn History: Duration • (Self-Selection Population N=1,251) • < 3 months 29 (2.3%) • 4-12 months 99 (7.9%) • 1-2 years 238 (19%) • 3-5 years 314 (25%) • > 5 years 567 (45%) 19

  20. Heartburn History: Frequency • (Self-Selection Population N=1,251) • < 1 day a week 169 (14%) • 2-3 days a week 425 (34%) • 4-5 days a week 164 (13%) • 6-7 days a week 489 (39%) 20

  21. Consultation for HB with Health Care Provider (HCP): Definition • Advice from a physician or supporting HCP, or • Use of a prescription HB medication • The contact was not confirmed • Specific information was not collected (what issue was discussed and what advice was given) 21

  22. Consultation for HB with HCPSelf-Selection Population (N=1,251) never (37%) within 1 year (46%) over 1 year (17%) 22

  23. Correct Self-Selection: Definition • HB > 2 days/week • > 18 years old • Not pregnant/lactating • Not allergic to omeprazole • No contraindicated symptoms that were not reported to HCP • No contraindicated medications that were not discussed with a HCP 23

  24. Correct Self-Selection: Results • Self-Selection Population (N=1,251) • Correct 76% (n=961) • Incorrect 24% (n=290) • HB < 1 day/week 169 • Contraindicated symptoms 134 • Contraindicated medications 15 • Age < 18 years 3 • Pregnant or nursing 1 24

  25. Purchasing Patterns • Purchase Population (N=854) • 94% (799) 1 carton* • 2% (20) 2 cartons • 1% (8) 3 cartons • 3% (27) 4 cartons • * Each carton contained 14 tablets 25

  26. Compliance with Labeled Directions • Treated Population (N=758) • Compliant 478 (63%) • Not compliant: 280 (27%) • Exceeded 1 dose per day 69 (9%) • Exceeded 1 tablet per dose 31 (4%) • Exceeded 14 consecutive days 23 (3%) • Took for less than 14 days 249 (33%) 26

  27. Return of Frequent HeartburnTreated Population available for 3-month follow-up (N=649) • 43% (n=276) Did not have HB • 57% (n=373) Frequent HB returned: • 46% (171) Antacid HB medicine • 27% (99) Rx HB medicine • 21% (78) OTC acid reducer • 20% (75) Consulted HCP • 10% (36) Changed lifestyle • 6% (22) Did not do anything 27

  28. Study Limitations • Relatively short duration (3 months) • Did not address if Prilosec1 will be used intermittently (few courses over a year) • Did not address the concomitant usage of other HB medications • Did not assess if consumers understand that Prilosec1 is not for relief of acute HB 28

  29. Actual Use Study: Conclusions • Most of the consumers who self-selected Prilosec1 as appropriate for their use had a long history of frequent HB 29

  30. Overall Conclusions (cont.) • Even though the label stated to see HCP prior to the use of Prilosec1, 1/3 of the subjects did not do so • More than half of the treated population had their HB return: • Majority switched to other HB medicine (Rx or OTC) • 1/5 went to see their HCP • Unclear how the interaction with HCP prior or after the use of Prilosec1 would have influenced consumer behavior 30

  31. Overall Conclusions (cont.) • Prilosec1 is likely to be used by consumers with contraindicated symptoms • Prilosec1 is likely to be used by consumers with infrequent HB 31

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