Transcript Prilosec1 20 mg Tablets Rx to OTC Switch Daiva Shetty, M.D.

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
•
•
•
•
2
Regulatory History
Proposed Label
Target Population
Actual Use Study #007
Differences Between the Original
and Resubmission NDA
3
Original
Resubmitted
Dose
10 mg
20 mg
Target Population
> 12 years
Anybody with HB
> 18 years
HB > 2 x/week
Uses
Relief and prevention
Prevention of
frequent HB
Duration
10 days
(intermittent)
14 days
(continuous)
Overview of the Program
• Actual Use Study
– #007
• Three Label Comprehension Studies
– #02255
– #12179
– #17859
• Proposed OTC Labeling
• Safety Update
4
Prilosec1® Rx to OTC Switch: Overview
•
•
•
•
5
Regulatory History
Proposed Label
Target Population
Actual Use Study #007
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
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
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
Prilosec1® Rx to OTC Switch: Overview
•
•
•
•
9
Regulatory History
Proposed Label
Target Population
Actual Use Study #007
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
Actual Use Study #007: Study Design
•
•
•
•
•
11
Multi-center
Open-label
All-comers
Minimal inclusion/exclusion criteria
3-month duration
Primary Objective
How consumers use omeprazole in
naturalistic OTC conditions following
proposed labeling instructions
12
Results: Self-Selection
Participated in a self-selection interview
Answer not available
Self-selected product “Not appropriate”
Self-selected product “Appropriate”
(Self-Selection Population)
Answer not available
Subject < 18 years of age
Chose not to participate
Chose to participate
13
1,301
1
49
1,251
1
3
384
863
Chose Not to Participate
• Study participation inconvenient
• Don’t try new medicine without
MD approval
• Happy with current HB medication
• Too expensive
• Don’t use medication
• Other
14
N=384
115
104
32
19
5
113
Chose to Participate N=863
Did not meet study criteria
Purchased study medication
Did not return any diaries
Lost to follow-up
Withdrew consent
Adverse event
Investigator decision
Returned one or more diaries
15
9
854
92
82
8
1
1
762
Returned One or More Diaries N=762
Returned blank diaries
Returned diaries & used study drug
(Treated population)
Not available for 3-month follow-up
Available for 3-month follow-up
16
4
758
109
649
Subject Disposition: Summary
Participated in Self-Selection Interview
(N=1,301)
Stated that Prilosec1 is Appropriate for Them to Use
Self-Selection Population
(N=1,251)
Decided to Participate
(N=866)
Purchased Study Medication
(N=854)
Completed the Study by Returning Diaries
(N=762)
Treated Population
(N=758)
17
+
Excluded from Study
(N=12)
Demographics
(Self-Selection Population N=1,251)
•
•
•
•
•
•
•
18
59% Females
16-91 Years of age, mean 48
65% Caucasian
18% Black
2% Asian
1.2% American Indian
9.4% Low Literacy Group
Heartburn History: Duration
(Self-Selection Population N=1,251)
< 3 months
4-12 months
1-2 years
3-5 years
> 5 years
19
29 (2.3%)
99 (7.9%)
238 (19%)
314 (25%)
567 (45%)
Heartburn History: Frequency
(Self-Selection Population N=1,251)
< 1 day a week
2-3 days a week
4-5 days a week
6-7 days a week
20
169 (14%)
425 (34%)
164 (13%)
489 (39%)
Consultation for HB with Health Care
Provider (HCP): Definition
•
•
•
•
21
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)
Consultation for HB with HCP
Self-Selection Population (N=1,251)
never
(37%)
over 1 year
(17%)
22
within 1 year
(46%)
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
Correct Self-Selection: Results
Self-Selection Population (N=1,251)
Correct
Incorrect
•
•
•
•
•
24
HB < 1 day/week
Contraindicated symptoms
Contraindicated medications
Age < 18 years
Pregnant or nursing
76% (n=961)
24% (n=290)
169
134
15
3
1
Purchasing Patterns
Purchase Population (N=854)
•
•
•
•
25
94% (799) 1 carton*
2% (20) 2 cartons
1% (8) 3 cartons
3% (27) 4 cartons
* Each carton contained 14 tablets
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%)
26
Took for less than 14 days
249 (33%)
Return of Frequent Heartburn
Treated Population available for 3-month follow-up (N=649)
• 43% (n=276) Did not have HB
• 57% (n=373) Frequent HB returned:
–
–
–
–
–
–
27
46% (171)
27% (99)
21% (78)
20% (75)
10% (36)
6% (22)
Antacid HB medicine
Rx HB medicine
OTC acid reducer
Consulted HCP
Changed lifestyle
Did not do anything
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
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
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
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