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Omeprazole Magnesium

Omeprazole Magnesium. Keith C. Triebwasser, Ph.D. Senior Director Regulatory Affairs Procter & Gamble. Rx to OTC Switch. Omeprazole for the Prevention of Frequent Heartburn Symptoms. Target Population: People with Frequent Heartburn.

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Omeprazole Magnesium

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  1. Omeprazole Magnesium Keith C. Triebwasser, Ph.D. Senior DirectorRegulatory AffairsProcter & Gamble

  2. Rx to OTC Switch Omeprazolefor the Prevention ofFrequent Heartburn Symptoms

  3. Target Population: People withFrequent Heartburn • Heartburn symptoms 2 or more days per week (40 million people) • Affects their daily lives • Goal: to prevent vs. treat symptoms

  4. Target Population Tries to Manage Frequent Heartburn • 77% use OTC medications • OTC product use - 80% use antacids - 48% use OTC H2RAs - 38% use both • Only 19% report satisfaction

  5. Current OTC Therapies Not Well-Suitedfor People with Frequent Heartburn • Pharmacology limits effectiveness • Short duration of action • Intended for episodic heartburn • Current therapies lack all day efficacy

  6. Omeprazole Ideally Suited for Target Population • Pharmacology provides for • Prolonged acid suppression • 24 hour prevention of symptoms • Once daily dosing

  7. Omeprazole Ideally Suited for Target Population • Omeprazole’s excellent safety profile • 15 years • 125 countries • 450 million patient treatments

  8. OTC Label Label clearly directs consumers: • How to select the product • How to use the product • What to do if symptoms continueor return

  9. OTC Label Elements • Target population • Frequent heartburn sufferers (2 or more days/week) • Indication • Prevention of the symptoms of frequent heartburn for 24 hours

  10. OTC Label Elements • Target population • Frequent heartburn sufferers (2 or more days/week) • Indication • Prevention of the symptoms of frequent heartburn for 24 hours • Dose • 20 mg of omeprazole as omeprazole magnesium

  11. OTC Label Elements • Target population • Frequent heartburn sufferers (2 or more days/week) • Indication • Prevention of the symptoms of frequent heartburn for 24 hours • Dose • 20 mg of omeprazole as omeprazole magnesium • Directions for use • Take 1 tablet in the morning

  12. OTC Label Elements • Target population • Frequent heartburn sufferers (2 or more days/week) • Indication • Prevention of the symptoms of frequent heartburn for 24 hours • Dose • 20 mg of omeprazole as omeprazole magnesium • Directions for use • Take 1 tablet in the morning • Take every day for 14 consecutive days

  13. OTC Label Elements • Target population • Frequent heartburn sufferers (2 or more days/week) • Indication • Prevention of the symptoms of frequent heartburn for 24 hours • Dose • 20 mg of omeprazole as omeprazole magnesium • Directions for use • Take 1 tablet in the morning • Take every day for 14 days • Instructions to see a doctor • If you have warning signs • If heartburn continues or returns

  14. Omeprazole, properly labeled, can be safely and effectively used in an OTC setting

  15. Presentation Agenda OTC Omeprazole for Frequent Heartburn David Peura, M.D.Professor of MedicineAssociate Chief of Gastroenterology, University of Virginia Efficacy and Consumer Use Douglas Bierer, Ph.D.Director, OTC Drug Development, The Procter & Gamble Co. Safety Douglas Levine, M.D.Chief Medical Officer, AstraZeneca LP Safe Use in OTC Setting Nora Zorich, M.D., Ph.D.Vice President, Pharmaceuticals, The Procter & Gamble Co. Summary Keith Triebwasser, Ph.D.Senior Director, Regulatory Affairs, The Procter & Gamble Co.

  16. Proposed OmeprazoleRX to OTC Switch:A Clinician’s Perspective David Peura, M.D. FACP FACG Professor of MedicineAssociate Chief of Gastroenterology and HepatologyUniversity of Virginia

  17. Gap in OTC Therapy for Frequent Heartburn • Heartburn frequency varies • Current OTC meds are inadequate therapy for frequent HB • Condition does not require intensive physician involvement • Consumers could self-manage frequent HB with effective OTC therapy

  18. Current Physician ExperienceWith PPIs and Frequent Heartburn • More than 50% GI patients on PPIs • Primary care physicians comfortable prescribing PPIs for frequent heartburn • Endoscopy/diagnostic tests unnecessary for uncomplicated frequent heartburn • Symptom management/prevention is current practice

  19. OTC Omeprazole Consistent withCurrent Practice Guidelines Therapy should be aimed at treating or preventing heartburn symptoms with acid-reducing medications

  20. Frequent Heartburn Can Be Self-Managed With OTC Omeprazole • Label encourages people to see their doctor • People will continue to see doctors • Low risk/high benefit to consumer

  21. OTC Omeprazole Would Benefit Consumers • Symptom prevention is key • PPI best therapy to prevent frequent heartburn symptoms • Proposed dose and duration appropriate • Omeprazole safe and effective

  22. Efficacy and Consumer Use Douglas Ws. Bierer, Ph.D. Director, OTC Drug DevelopmentProcter & Gamble

  23. Efficacy and ConsumerBehavior Program • Pivotal efficacy studies • Consumer understanding and behavior studies • Label comprehension • Appropriate OTC use

  24. Efficacy Trials • Two efficacy trials • Study populations • Heartburn symptoms > 2 days a week • No physician diagnosis of GERD or erosive esophagitis • Dosing • One tablet in the morning for14 consecutive days • Endpoint • % subjects heartburn-free • % days heartburn-free

  25. Percent of Subjects Heartburn Free For24 Hours: Time Course Over 14 Days Study 183 20 mg OME Study 17120 mg OME Study 183Placebo Study 171Placebo 90 80 70 60 50 % Subjects With No Heartburn 40 30 20 10 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Time (days) * p < .001 (day 1, day 14, across 14 days)

  26. Conclusion: Efficacy Studies • 20 mg provides prevention of heartburn symptoms for 24 hours • Uses:For the prevention of the symptoms offrequent heartburn for 24 hours • Dose:20 mg • Directions:1 tablet in the morning for 14 consecutive days

  27. Consumer Understanding and Behavior Program • Objectives • Correct self-selection • Understand how to use product • Understand and adhere to product warnings • Studies • Label comprehension • Actual use

  28. Subjects recruited from 12 sites across U.S. n=684 Study population Infrequent or no heartburn Frequent heartburn Low-literacy with frequent heartburn Potential drug-drug interactions Pregnant/nursing Label Comprehension Study Design

  29. Label Comprehension Study ResultsWho Should Use the Product Infrequent/No Heartburn 22% 78%Chose Correctly n=229

  30. Label Comprehension Study ResultsWho Should Use the Product FrequentHeartburn 1% 99%Chose Correctly n=200

  31. Frequent heartburn situations 79% Infrequent heartburn situations 49% Label Comprehension of Low LiteratePeople with Frequent Heartburn % CorrectResponse(n=162)

  32. 1 tablet per day 95% Take for 14 consecutive days 91% Contact healthcare professional before using beyond 14 days 92% Subjects Understood How to Usethe Product

  33. Subjects Understood When Not toUse/Ask a Health Professional • General warning signs 81% • Drug-drug interactions • Generic + brand names 82% • Generic names alone 50% • Pregnant/nursing 91%

  34. Actual Use Study: Objectives • Evaluate consumer use in naturalistic OTC setting • Correct self-selection • Appropriate use • Complied with label instructions

  35. Actual Use Study Design • Design mimicked consumer purchase decisions: • Mall kiosk site – not clinical site • No health care professional on site • No subject contact in use phase • Purchase product • Product repurchase allowed

  36. Study Phases Self Selection Decision At Mall Kiosk Product Use/Repurchase 8 Week Period Follow-UpInterview 4 Weeks After Usage Period

  37. Disposition of Subjects Population Approached at Mall n = 5060 No Heartburn/Not Interested Not Appropriate to use n = 3809 Said They Could Use Product n = 1251 Would Not Purchase n = 385 Agreed to Purchase Product [Self-Selection Population] n = 866

  38. Demographics of Self-Selection Population Characteristic Gender (% female) 58% Race % Caucasian 68% % African American 16% % Hispanic 11% Mean age/range 48/18-91 Low reading ability (REALM Test) 8% Heartburn symptoms  2days/wk 90% Use OTC heartburn medications 90% Use Rx heartburn medications 40% n=866

  39. Results of Self-Selection Correct self-selection ofall 6 selection criteria: 81% • Heartburn  2 days per week •  18 years of age • Not allergic to omeprazole • Not pregnant or nursing • No general warning signs • No drug-drug interactions n=866

  40. < 18 years of age 3 Pregnant/nursing 1 Allergic to omeprazole 0 General warning signs 82 Drug-drug interactions 8 Infrequent heartburn 86 People Who Did Not CorrectlySelf- Select n=866 Numberof Subjects

  41. Disposition of Subjects WhoPurchased Product Agreed to Purchase Product [Self-Selection Population] n = 866 No Diary n = 96 WithdrewConsent n = 4 Did Not MeetStudy Criteria n = 8 Used Product and Returned Diary [Use Population] n = 758

  42. Subjects Are Compliant WithDosing Directions • No more than 1 tablet per dose 96% 99% • No more than 1 tablet per day 91% 98% Per Subject Per Dosing Occasion

  43. Compliance With the 14-DayDosing Regimen • Definition of compliance • 80-100% of the product within14 ± 3 days • Physician consultation if exceeded 14 doses • (11-14 doses within 11-17 days)

  44. Compliance With the 14-DayDosing Regimen People achieved high compliance withdosing directions 9% 11-14 doses in > 17 days 9% < 11 doses < 1% Multiple daily doses 3% > 14 doses w/o doctor contact 79%Accordingto label directions

  45. Return of Frequent HeartburnFour Weeks After Trial No Medication 8% Antacids No FrequentHeartburn 22% 43% H2RA 9% Antacids + H2RAs 3% Rx Therapy 15%

  46. Actual Use Study: Conclusions • Consumers appropriately self-select • Consumers understood the label • Consumers used product for prevention of frequent heartburn • Consumers used omeprazole according to label directions

  47. Summary • Indication • Prevention of the symptoms of frequent heartburn for 24 hours • Dose • 20 mg of omeprazole as omeprazole magnesium • Directions for use • Take 1 tablet in the morning • Take every day for 14 days

  48. Our proposed label, the efficacy data and the consumer’s abilityto understand and use this product safely and appropriately are congruent

  49. OTC OmeprazoleUpdate on Safety Doug Levine, M.D. Chief Medical OfficerAstraZeneca LP

  50. OTC Omeprazole Product Safety Product safety is defined as adverse events occurring in relation to product use during short or long term Safety of omeprazole is established based on: • Clinical trials with Rx product • Rx post-marketing surveillance • OTC clinical trials Adverse event profile of omeprazole is established, and is acceptable for OTC

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