Lower Back Pain

September 14, 2015

Collegium Pharmaceutical reported results of a phase III trial of Xtampza ER (oxycodone extended-release capsules) for moderate-to-severe chronic low back pain. The multicenter, randomized, double-blind, enriched enrollment, randomized withdrawal, placebo-controlled study met its primary endpoint, which showed a statistically significant difference in average pain intensity from Randomization Baseline to week 12 between the Xtampza ER and placebo groups (p<0.0001). All sensitivity analyses of the primary endpoint also were statistically significant. Xtampza ER had an adverse event profile consistent with other opioids, was well-tolerated, and no new safety concerns were identified. The company is seeking FDA approval for Xtampza ER.

January 26, 2015

Mesoblast has issued positive results of a phase II program of MPC-06-ID for the treatment of chronic low back pain due to degenerative disc disease. In the randomized, placebo-controlled trial of 100 patients, a single injection of Mesoblast’s allogeneic investigational mesenchymal precursor cell (MPC) product, MPC-06-ID, was welltolerated. A single injection of 6 million MPCs induced substantial and sustained pain relief over 24 months. At 12 and 24 months, 46% and 48% of MPC-06-ID-treated patients achieved minimal or no residual pain (VAS less than or equal to 20) compared with 13% and 13% of saline treated patients, p=0.042 and 0.093, respectively. In patients who received a single injection of six or 18 million MPCs, 44% and 42%, respectively, achieved the target composite endpoint of treatment success at both six and 12 months (50% reduction in pain, 15-point improvement in function and no further treatment intervention), compared with 13% of saline controls (p=0.006 and p=020). In patients who received six million MPCs and achieved the target composite endpoint of treatment success at both six and 12 months, 86% (11 of 13) maintained treatment success at 24 months (32% v. 11% saline controls, p=0.001). The phase III program for this indication has been initiated.

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, enriched-enrollment, randomized-withdrawal, 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 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.

March 30, 2009

NeuroMed issued positive results from a phase III trial of Exalgo for the treatment of chronic pain. This US-based, randomized withdrawal, placebo-controlled, double-blind trial enrolled 268 opioid-tolerant subjects with chronic moderate to severe low back pain. The subjects received placebo or Exalgo at doses between 12 mg and 64 mg. The primary endpoint was the mean change from baseline to week 12 in pain intensity, assessed by an 11 point Likert Numerical Rating Scale (NRS). The study showed statistically significant results in the specified primary efficacy endpoint (p<0.0001). Results from multiple secondary efficacy endpoints were consistent with the primary efficacy endpoint. The overall safety profile and reported adverse events in the study were consistent with that of other opioids.

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.