1 / 31

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.

eshana
Download Presentation

Prilosec1 ® 20 mg Tablets Rx to OTC Switch

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

More Related