May 14 2012
S.L.A. Pharma AG has announced clinically and statistically significant top-line data from their Phase 2 double blind randomised placebo controlled study. The study was designed to evaluate the safety and efficacy of 4 doses of Nalcol™, a novel oral formulation of naloxone (2.5, 5, 10, and 20 mg), in treating opioid induced constipation (OIC) in patients with persistent non-cancer pain.
Statistical significance for increasing spontaneous bowel movements (SBMs) against placebo and baseline were displayed by various doses of Nalcol™. Increases in SBMs were dose-related with clinically significant effects (greater than 3 SBMs per week) observed in the 5, 10, and 20 mg doses. Patients receiving the 20 mg Nalcol™ dose displayed the greatest benefit in their SBMs, increasing from an average of 1 per week to over 6 per week. The proportion of patients obtaining clinical benefit in the 5, 10 and 20 mg treatment groups was more than twice that of the placebo group. Importantly clinical benefits were sustained throughout the treatment periods.
During the study doses of Nalcol™ and placebo were trialled once-daily for 3 weeks followed by twice-daily for 3 weeks on 40 patients. At entry patients were required to have fewer than 3 SBMs per week, however, during the baseline period the enrolled patient average was 1 SBM per week. There were no differences between groups in subjective or objective measures of opioid withdrawal or patient reported pain.
"We are delighted that Nalcol has achieved both clinical and statistical significance in treating opioid induced constipation. We are now seeking licensing partners to progress the clinical development into Phase 3 and towards regulatory approval." stated Justin Slagel, CEO.