The investigational drug CAM2038 (buprenorphine; Braeburn), currently under review for the treatment of moderate-to-severe opioid use disorder, demonstrated a reduction in chronic low back pain (CLBP) compared to placebo in patients previously on long-term daily opioid therapy.
The preliminary findings come from the multicenter, double-blind, randomized withdrawal, placebo-controlled Phase 3 HS-16-555 trial (N=340), which enrolled patients who had been treated with opioids for moderate-to-severe CLBP for a minimum of 3 months prior to trial screening. The patients were randomized to receive CAM2038 50mg/mL once weekly at doses of 8mg, 12mg, 16mg, 24mg, or 32mg; CAM2038 356mg/mL once monthly at doses of 64mg, 96mg, or 128mg; or placebo.
The primary endpoint of change in Average Pain Intensity (API) from baseline to week 12 was achieved by the CAM2038 group, who experienced a statistically significant reduction in pain vs the placebo group (P <.001, mITT, effect size 1.03). A secondary endpoint of Worst Pain Intensity (WPI) was also statistically significantly reduced in the treatment group compared to placebo at week 12 (P <.001, effect size 1.11)
CAM2038 is a buprenorphine depot subcutaneous injection, designed as prefilled syringes for once weekly and once monthly formulations that provides sustained buprenorphine release. It is intended for use as part of a comprehensive treatment plan to include counseling and psychosocial support. The FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 for recommending approval of CAM2038. The FDA has set a Prescription Drug User Fee Action (PDUFA) date of December 26, 2018.
The long-term safety of CAM2038 is being evaluated in a 52-week open label extension study.
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