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Chronic Back Pain
August 18, 2014
Collegium Pharmaceutical issued results
of a phase III study of Oxycodone DETERx
for the treatment of patients with moderate-to-
severe chronic low back pain. The phase
III study was a multicenter, double-blind,
placebo-controlled study of Oxycodone DETERx
versus placebo in opioid-experienced and
opioid-naïve subjects with moderate-to-severe
chronic low back pain. Patients who achieved a
stable and effective dose of Oxycodone DETERx
during the open-label titration phase were
randomized (n=389) into the 12-week, double-blind
maintenance phase, in which they either
were maintained on their current dose regimen
of Oxycodone DETERx or were tapered to
placebo. The primary efficacy endpoint of the
study was the change in average pain intensity
from baseline to week 12; pain was measured
using an 11-point pain intensity numerical
rating scale (PI-NRS). The study met the primary
efficacy endpoint, showing patients with
chronic low back pain treated with Oxycodone
DETERx experienced a statistically significant
reduction in pain compared with placebo (p<
0.0001). The company is positioned to file an
NDA with the FDA for Oxycodone DETERx by
the end of 2014.
August 20, 2012
Eli Lilly released results from a phase III trial of Forteo (teriparatide injection) compared to risedronate for the treatment of back pain. This randomized, double-blind, double-dummy, active-controlled study enrolled 710 postmenopausal women with at least one moderate or severe vertebral fracture thought to be the cause of back pain. Subjects received either Forteo 20mg/day or risedronate 35mg/week for 18 months. From baseline to six months, data showed no difference between Forteo (59.2%) and risedronate (57.4%) on the primary endpoint of at least a 30% reduction in worst back pain, as assessed by a numeric rating scale in each treatment group. However, there were statistically significant differences in favor of Forteo in some exploratory measures, including greater increases in bone mineral density (BMD) and fewer patients with new vertebral fractures. Furthermore, significantly fewer patients treated with Forteo experienced a worsening of average back pain between six and 18 months (23.6% versus 30.6% of risedronate-treated patients; p=0.04). Forteo was well tolerated. The most frequent adverse events were similar between both treatment groups. Eli Lilly did not note its plans for Forteo.
August 29, 2011
Zogenix released results from a phase III trial of Zohydro (extended release hydrocodone bitartrate) for the treatment of chronic pain. This US-based, randomized, double blind, placebo controlled trial enrolled approximately 600 subjects with chronic low back pain and inadequate pain relief from their existing therapy. The subjects received Zohydro capsules (20-100 mg) or placebo every 12 hours. The primary endpoint was the mean change from baseline to the end of 12 weeks of treatment in the average 24-hour pain intensity ratings based on the 0-10 Numerical Rating Scale. Zohydro resulted in significantly (p≡0.008) improved chronic pain relief compared to placebo. The two key secondary endpoints were also met: the proportion of subjects with at least 30% improvement in pain intensity and the improvement of overall satisfaction of medication.
May 1, 2006
Dov Pharmaceutical reported negative results of a phase III trial of bicifadine, for the treatment of chronic lower back pain. Results from the study failed to meet their primary efficacy endpoint, with none of the three trial doses yielding significant improvements on the patient-reported Visual Analog Scale, relative to placebo. Preliminary evidence of a high placebo response was noted. This multi-center, double-blind, placebo-controlled study enrolled 600 subjects in the US, who received one of 3 oral doses of the drug (200 mg, 300 mg or 400 mg) or placebo twice daily for 12 weeks. Additional analyses of study data were ongoing.
March 28, 2005
Pain Therapeutics issued positive results of a phase III trial of their investigational opiod analgesic Oxytrex. Results from the study demonstrated a superior tolerability and cessation profile, with subjects receiving Oxytrex experiencing over 50% less symptoms of physical dependence and withdrawal effects after cessation of high-dose therapy, vs. approved therapy with oxycodone (p<0.01). Incidence of certain opioid-related side effects during treatment were also significantly lower, including somnolence (p<0.05), pruritus (p<0.05) and moderate-to-severe constipation (p<0.05), vs. oxycodone. Analgesic efficacy was found to be non-inferior to the approved drug. This randomized, double-blind, placebo and active-controlled trial enrolled 719 patients with persistent moderate-to-severe low-back pain at sites in the US. Following a 4-10 day washout, subjects were enrolled into one of four dosing cohorts: Oxytrex twice daily (n=206), Oxytrex four times daily (n=206), oxycodone four times daily (n=206), or placebo (n=101) for 6 weeks of dose-escalation (maximum dose: 80 mg), followed by 3 months of fixed dose treatment and follow-up observation of withdrawal symptoms.
March 24, 2003
Endo Pharmaceuticals reported positive results from a series of phase IV trials investigating Lidoderm (lidocaine patch 5%) for the treatment of pain. The first study a randomized, open-label, multicenter, two-week pilot study designed to assess the impact of Lidoderm in subjects with postherpetic neuralgia (PHN), diabetic neuropathy (DN), or low back pain. Results showed that addition of Lidoderm reduced most pain interference in the PHN group and all interference in the DN and back pain groups. In the second study, an open-label, two-week pilot study of low back pain, subjects were treated with the patch for two weeks. Results showed that Lidoderm produced significant improvements in pain intensity in all groups and the treatment was well tolerated. Positive results were also reported in trials for the treatment of osteoarthritis knee pain and diabetic neuropathy.
January 21, 2002
Phase III trial results indicate that Biovail's extended release tramadol formulation (Tramadol ER) produces statistically significant dose-related reductions in chronic low back pain. The trial included an open label run-in phase to identify subjects for continuation in a double-blind phase. At the beginning of the double-blind treatment phase, approximately 380 eligible subjects were randomly assigned to receive Tramadol ER 300 mg, Tramadol ER 200 mg or placebo. At the first time point evaluated (Week 1), Tramadol ER was statistically superior to placebo in reducing pain, with the Tramadol ER 300 mg dose demonstrating more effectiveness than the 200 mg dose. The effects of Tramadol ER were sustained over the 12-week duration of the double-blind phase.