New Formulation of Sustained Release Naloxone Can Reverse Opioid Induced Constipation Without Compromising the Desired Opioid Effects

摘要: An international double-blind randomized placebo controlled study evaluated the safety and efficacy of four doses a new sustained release naloxone capsule to treat Opioid Induced Constipation (OIC). Methods Forty patients taking opioids for noncancer related pain, experiencing OIC, were into 4 cohorts 10 patients. A multiple ascending dose design was used evaluate 2.5 mg, 5 20 mg (NSR) capsules vs placebo. Drug given once-daily 3 weeks followed by twice daily (bid) dosing between 6. Results The incidence treatment emergent adverse events highest in group. among active groups similar. There no serious events. number severe low overall but Significant improvements seen Spontaneous Bowel Movements with NSR capsules. Mean change SBMs from baseline 2.21 ( P = 0.052), 2.37 0.032); 4.11 0.0005); 5.19 (<0.0001) noted respectively, when taken once daily, compared 1.38 0.2) on therapy. No changes subjective or objective measures opioid withdrawal as measured Subjective Withdrawal Scale Clinical observed. increase patient reported pain using visual analogue scale. Conclusions This Phase II has shown that formulation deliver oral colon allows successful OIC without comprising desired effects.