Oxymorphone Extended Release Effective, Tolerable for Patients with Depression

Las Vegas—In a post-hoc analysis of 2 randomized trials, patients with depression who took oxymorphone extended release for chronic lower back pain achieved similar levels of efficacy and safety compared with patients taking the medication who did not suffer from depression. The likelihood of adverse events (AEs) associated with oxymorphone extended release was similar between the depression and no depression groups. The results were presented at the AAPM meeting during a poster presentation titled Oxymorphone Extended Release in Patients with Depression.

The studies enrolled 575 men and women who were ≥18 years of age and had chronic low back pain, including 250 opioid-experienced and 325 opioid-naïve patients. To be included, opioid-naïve patients had to have received <5 mg/day of oxycodone or an equianalgesic opioid equivalent in the 2 weeks before screening, while opioid-experienced patients had to have received opioid therapy equivalent to 60 to 660 mg/day of oral morphine in the same time period. Patients were excluded if they had fibromyalgia, reflex sympathetic dystrophy or causalgia, acute spinal cord compression, meningitis, diskitis, infection- or tumor-related back pain, or surgery to resolve back pain within the previous 6 months.

The 2 studies each began with a ≤4-week open-label titration and then a 12-week, double-blind treatment period. During titration, the opioid-naïve patients received 5 mg of oxymorphone extended release every 12 hours, while the opioid-experienced patients received a dose of oxymorphone extended release equivalent to their current opioid therapy. They received 5 to 10 mg of oxymorphone extended release every 12 hours for 3 to 7 days until reaching a stable dose. Afterward, they began the randomized phase, during which they received oxymorphone extended release or placebo.

Of the 575 patients in the titration phase, 132 (23%) had a medical history of depression. The baseline characteristics were similar in the depression and no-depression groups. The mean age was approximately 50 years, the mean body mass index was approximately 30 kg/m2, and approximately 90% of patients were white. However, 30.3% of patients in the depression group were men compared with 53.7% in the no-depression group. In addition, 175 patients were entered into the randomized phase after achieving a stable dose of oxymorphone extended release: 39 patients with depression and 136 patients without depression.

The results indicated oxymorphone extended release was safe. In the titration phase, 56.8% of patients with depression and 61.6% of patients without depression had an effective, well-tolerated dose of the drug. Treatment-related AEs were similar, as well, occurring in 57.6% of patients with depression and 58.7% of patients without depression. Among patients who received oxymorphone extended release during the double-blind period, 23.1% of patients with depression had a treatment-related AE compared with 27.2% of patients who did not suffer from depression.

There were no statistically significant differences between patients who suffered from depression and those who were not depressed in any of the AEs, including constipation, nausea, somnolence, headache, dizziness, or pruritus. After 12 weeks of the double-blind period, the mean change from baseline in the visual analog scale (VAS) was 8.4 in patients who took oxymorphone extended release and had depression compared with 10.0 for patients who took oxymorphone extended release but did not have depression (P=.71). Meanwhile, the mean change from baseline in the VAS was 38.8 in patients who took placebo and had depression compared with 25.9 for patients who took oxymorphone extended release but did not have depression (P=.01). This study was supported by Endo Pharmaceuticals, Inc.