Study 33CL231 will explore the analgesic efficacy of ADL5859 in treating pain associated with diabetic peripheral neuropathy. The study is a double-blind trial expected to enroll approximately 210 patients experiencing pain associated with diabetic peripheral neuropathy. Following a seven-day baseline period, patients will be randomized to receive a four-week treatment of either placebo, ADL5859, or the active control, duloxetine. The primary measure of efficacy for the study will be the change in mean pain intensity score.
Recently, Adolor and Pfizer entered into a collaboration to develop and commercialize two delta opioid agonist compounds, including ADL5859, for the treatment of a range of inflammatory, neuropathic and acute pain conditions.
Michael Dougherty, president and CEO of Adolor, said: “We are pleased to be advancing the clinical development of ADL5859. This is our third Phase IIa ADL5859 study and the first one announced since our collaboration with Pfizer earlier this month.”