OPANA ER (oxymorphone HCI)
Clinical Studies
Proven Durable Efficacy in Opioid-Naïve Patients
89% of patients who completed the study maintained the analgesic effect of OPANA® ER over a 3-month period.3
A 12-Week Randomized Placebo-controlled Trial Assessing the Safety and Efficacy of Oxymorphone Extended Release for Opioid-Naïve Patients with Chronic Lower Back Pain1, 3
- 81% of chronic pain patients on OPANA ER had ≥ 30% pain score reduction compared with 52% of patients on placebo (P<0.0001).3
- Greater than 70% of patients on OPANA ER achieved a ≥ 50% pain score reduction.3
A 12-week, randomized, double-blind, placebo-controlled study in 325 opioid-naïve
patients with moderate to severe chronic low back pain. 4-week, open-label titration
phase: patients initiated on 5 mg of OPANA ER every 12 hours for 2 days, titrated as
needed at 5-10 mg increments every 12 hours every 3-7 days to stabilized dose.
Stabilization defined as adequate analgesia (≤40 mm on 100-mm VAS) for 3 of 5
consecutive days on the same OPANA ER dose. Stabilized patients (n=205)
randomized to their OPANA ER dose or to placebo for the 12-week, double-blind
treatment phase. Supplemental rescue medication during this period: OPANA®
(oxymorphone hydrochloride) 5 mg every 4-6 hrs prn during first 4 days; then
restricted to 2 daily doses (maximum of OPANA 10 mg per day).1
Adverse events reported in ≥ 5% of patients in this study3
|
Open-Label Titration Period |
Double-Blind Treatment Period |
| Preferred Term |
OPANA ER (n=325) |
OPANA ER (N=105) |
PLACEBO (N=100) |
| Constipation |
26.2% |
6.7% |
1.0% |
| Somnolence |
19.1% |
1.9% |
0% |
| Nausea |
18.2% |
11.4% |
9.0% |
| Dizziness |
11.1% |
4.8% |
3.0% |
| Headache |
10.5% |
3.8% |
2.0% |
| Pruritis |
6.8% |
2.9% |
1.0% |
Please see Important Safety Information, including boxed WARNING. Get the full Prescribing Information for OPANA ER.
Proven Durable Efficacy in Opioid-Experienced Patients
80% of patients who completed the study maintained the analgesic effect of OPANA ER over a 3-month period2
Efficacy and Safety of OPANA ER (Oxymorphone Extended Release) for Relief of Moderate to Severe Chronic Low Back Pain in Opioid-Experienced patients -- A 12-week, randomized, double-blind, placebo-controlled study2, 3
- 80% of patients on OPANA ER had ≥ 30% pain score reduction compared with 35% of patients on placebo (P<0.0001)3, 4
- Greater than 60% of patients achieved a ≥ 50% pain score reduction4
A 12-week, randomized, double-blind, placebo-controlled study in 250 opioid-experienced
patients with moderate to severe chronic low back pain who were on
a stable opioid dose (≥60 mg morphine equivalents) for at least 2 weeks prior to
screening. 4-week, open-label titration phase: patients initiated on every-12-hour dose
of OPANA ER approximately equivalent to pre-study opioid dose, titrated at 10 mg
increments every 12 hours every 3-7 days to stabilized dose. Supplemental rescue
medication during this period: OPANA® (oxymorphone hydrochloride) 5 mg every
4-6 hrs prn. Stabilization defined as adequate analgesia (≤40 mm on 100-mm VAS)
for 3 of 5 consecutive days on the same OPANA ER dose, with ≤2 doses/day of rescue
medication. Stabilized patients (n=142) randomized to their OPANA ER dose or to
placebo for the 12-week, double-blind treatment phase. Supplemental rescue
medication during this period: OPANA 5 mg every 4-6 hrs prn during first 4 days;
then restricted to 2 daily doses (maximum of OPANA 10 mg per day).2
Adverse events reported in ≥ 5% of patients in this study3
|
Open-Label Titration Period |
Double-Blind Treatment Period |
| Preferred Term |
OPANA ER (n=250) |
OPANA ER (N=70) |
PLACEBO (N=72) |
| Nausea |
19.6% |
2.9% |
1.4% |
| Constipation |
11.6% |
5.7% |
1.4% |
| Headache |
11.6% |
2.9% |
0% |
| Somnolence |
11.2% |
2.9% |
0% |
| Vomiting |
8.8% |
0% |
1.4% |
| Pruritis |
7.6% |
0% |
0% |
| Dizziness |
6.4% |
0% |
0% |
Please see Important Safety Information, including boxed WARNING. Get the full Prescribing Information for OPANA ER.
References
- Katz N, Rauck R, Ahdieh H, et al. A 12-week, Randomized, Placebo-Controlled Trial Assessing the Safety and Efficacy of Oxymorphone Extended Release for Opioid-Naïve Patients with Chronic Low Back Pain. Cur Med Res Opin 2007;23(1):117-128.
- Hale ME, Ahdieh H, Ma T, Rauck R, for the Oxymorphone ER Study
Group 1. J Pain. 2007;8:175-184.
- OPANA ER Full Prescribing Information. Chadds Ford, PA: Endo Pharmaceuticals; 2008.
- Data on File, Endo Pharmaceuticals.
WARNING: OPANA ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.
Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OPANA ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
OPANA ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
OPANA ER is NOT intended for use as an as needed analgesic.
OPANA ER TABLETS are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed OPANA ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone.
Patients must not consume alcoholic beverages, or prescription or nonprescription medications containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone.
OPANA, like OPANA ER, contains oxymorphone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to morphine and can be abused in a manner similar to other opioid agonists, legal or illicit.
OPANA and OPANA ER are contraindicated in patients with a known hypersensitivity to oxymorphone hydrochloride, morphine analogs such as codeine, or any of the other ingredients of OPANA and OPANA ER; in patients with moderate or severe hepatic impairment or in any situation where opioids are contraindicated such as: patients with respiratory depression (in the absence of resuscitative equipment or in unmonitored settings), acute or severe bronchial asthma, hypercarbia, and in any patient who has or is suspected of having paralytic ileus.
OPANA ER is not indicated for pain in the immediate post-operative period (the first 12–24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. OPANA ER is only indicated for post-operative use if the patient is already receiving the drug prior to surgery or if the post-operative pain is expected to be moderate or severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines).
Respiratory depression is the chief hazard of OPANA and OPANA ER, particularly in elderly or debilitated patients. OPANA and OPANA ER should be administered with extreme caution to patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, central nervous system (CNS) depression, or coma.
Patients receiving other opioid analgesics, general anesthetics, phenothiazines or other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) may experience additive effects resulting in respiratory depression, hypotension, profound sedation, or coma.
OPANA and OPANA ER should be used with caution in elderly and debilitated patients and in patients who are known to be sensitive to CNS depressants, such as those with cardiovascular, pulmonary, renal, or hepatic disease. OPANA and OPANA ER should be used with caution in patients with mild hepatic impairment and in patients with moderate to severe renal impairment. These patients should be started cautiously with lower doses of OPANA or OPANA ER while carefully monitoring for side effects.
OPANA ER is not indicated for preemptive analgesia (administration preoperatively for the management of postoperative pain).
The most common adverse drug reactions (≥10%) reported at least once by patients treated with OPANA in the clinical trials were nausea and pyrexia. The most common adverse drug reactions (≥10%) in clinical trials for OPANA ER were nausea, constipation, dizziness (excluding vertigo), vomiting, pruritus, somnolence, headache, increased sweating, and sedation.
Patients and their families should be instructed to flush any OPANA and OPANA ER tablets that are no longer needed.
Please see full Prescribing Information for OPANA and full Prescribing Information, including boxed WARNING for OPANA ER.
Vermont prescribers, please see additional information for OPANA and OPANA ER.
Oxymorphone is also available in injectable form. For more information, please see the full prescribing information for OPANA Injection.
