10 mm increase in VAS score from Day 7 until the end of the study.
The proportion of patients with various degrees of improvement from screening to study endpoint is shown in Figure 2. The figure is cumulative, so that patients whose change from baseline is, for example, 30%, are also included at every level of improvement below 30%. Patients who did not complete the study were assigned 0% improvement.
Figure 2: Percent Reduction in Average Pain Intensity from Screening to Final Visit
Figure 2
Figure 2
Figure 2
16 HOW SUPPLIED/STORAGE AND HANDLING
OPANA ER tablets are supplied as follows:
5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.
7.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.
10 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.
NDC: 35356-820-30 Bottles of 30
NDC: 35356-820-60 Bottles of 60
NDC: 35356-820-90 Bottles of 90
15 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.
20 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.
NDC: 35356-825-30 Bottles of 30
NDC: 35356-825-60 Bottles of 60
NDC: 35356-825-90 Bottles of 90
30 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.
NDC: 35356-849-30 Bottles of 30
NDC: 35356-849-60 Bottles of 60
NDC: 35356-849-90 Bottles of 90
40 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.
NDC: 35356-848-30 Bottles of 30
NDC: 35356-848-60 Bottles of 60
NDC: 35356-848-90 Bottles of 90
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].
Dispense in tight container as defined in the USP, with a child-resistant closure (as required).
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide)
Abuse Potential
Inform patients that OPANA ER contains oxymorphone, a Schedule II controlled substance that is subject to abuse. Instruct patients not to share OPANA ER with others and to take steps to protect OPANA ER from theft or misuse.
Life-threatening Respiratory Depression
Discuss the risk of respiratory depression with patients, explaining that the risk is greatest when starting OPANA ER or when the dose is increased. Advise patients how to recognize respiratory depression and to seek medical attention if they are experiencing breathing difficulties.
Accidental Exposure
Instruct patients to take steps to store OPANA ER securely. Accidental exposure, especially in children, may result in serious harm or death. Advise patients to dispose of unused OPANA ER by flushing the tablets down the toilet.
Risks from Concomitant Use of Alcohol and other CN |
