May 28, 2012
Janssen Pharmaceuticals issued results from a phase III study of Nucynta ER (extended release) for the treatment of pain in diabetic peripheral neuropathy (DPN). This randomized-withdrawal, placebo-controlled study enrolled 459 adult patients who had moderate to severe, chronic painful DPN for six months or more and a history of analgesic use for painful DPN for three months or more. The trial was split into three phases: a three-week titration period during which the individually optimized Nucynta ER dose (100-250mg two times per day) was determined for each patient; a 12-week, double-blind maintenance phase, during which patients with a one-point or greater reduction in pain intensity from beginning to end of titration were randomized either to continue taking Nucynta ER (at their optimal dose) or to receive placebo; and a follow-up period with a clinic visit at four days and a telephone interview at 10-14 days after discontinuation of study drug. The study met its primary endpoint of a mean change in average pain intensity from baseline, which was reduced from 7.3 to 3.6 on the NRS 11-point scale. Adverse events experienced by patients included nausea, dizziness, constipation and somnolence. Janssen is currently waiting for the FDA to review Nucynta ERs Supplemental New Drug Application.
February 14, 2011
Epicept reported results from a phase IIb trial evaluating NP-1, a topical analgesic cream for chemotherapy-induced peripheral neuropathy (CPN) This multi-center, double-blind, randomized, placebo-controlled study enrolled 460 subjects who received treatment for six weeks. Data from the intent to treat (ITT) population showed that the change in average daily neuropathy intensity scores in the NP-1 group achieved a statistically significant reduction in CPN intensity versus placebo (p<0.001). In a pre-specified subgroup of the ITT population, subjects who had previously received taxane chemotherapy, data also showed a statistically significant reduction in average daily neuropathy intensity scores (p≡0.034). This subgroup constituted more than 50% of the ITT population. Secondary efficacy endpoints confirmed the superiority of NP-1 vs. placebo.
May 18, 2009
Quigley Pharma reported positive results from a phase IIb trial of QR-333 for the treatment of diabetic peripheral neuropathy. This double-blinded, placebo-controlled trial enrolled 140 subjects who received QR-333 or placebo, applied topically to the bottoms of their feet three times daily for 12 weeks. Data are from a subset of compliant subjects, approximately 50% of the original intent to treat population, who had measurable nerve activity at both the beginning and end of the study. Over the course of 12 weeks, QR-333 significantly improved both maximal conduction velocity (p≡0.05) and compound sensory amplitude (p≡0.05) in the sural nerve, two key measures of distal sensory nerve function. The mean improvement in nerve conduction velocity was 1.5 m/sec.