A phase 3, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability, and efficacy study of Xtampza ER in patients with moderate-to-severe chronic low back pain

Abstract

Opioid analgesics are commonly used for the treatment of chronic low back pain (CLBP); however, abuse potential is a major concern. This study used a randomized, double-blind, placebo-controlled, enriched-enrollment randomized-withdrawal study design to evaluate the safety, tolerability, and analgesic efficacy of an abuse-deterrent formulation of extended-release oxycodone, Xtampza ER, in opioid-naive and opioid-experienced adults with moderate-to-severe CLBP. Patients entered an open-label titration phase (N = 740); those who were successfully titrated on Xtampza ER (≥40 to ≤160 mg oxycodone hydrochloride equivalent per day) were randomized to active drug (N = 193) or placebo (N = 196) for 12 weeks. Primary efficacy results showed a statistically significant difference in average pain intensity from randomization baseline to treatment week 12 between the Xtampza ER and placebo groups (mean [±SE], -1.56 [0.267]; P < 0.0001). All sensitivity analyses results supported the primary result of the study. Secondary efficacy outcomes indicated that Xtampza ER vs placebo had more patients with improvement in patient global impression of change (26.4% vs 14.3%; P < 0.0001), longer time-to-exit from the study (58 vs 35 days; P = 0.0102), and a greater proportion of patients with ≥30% (49.2% vs 33.2%; P = 0.0013) and ≥50% (38.3% vs 24.5%; P = 0.0032) improvement in pain intensity. There was less rescue medication (acetaminophen) use in the Xtampza ER treatment group than in the placebo group. Xtampza ER had an adverse event profile consistent with other opioids and was well tolerated; no new safety concerns were identified. In conclusion, Xtampza ER resulted in clinically and statistically significant efficacy in patients with CLBP.

Oxycodone DETERx®: A Novel Abuse-Deterrent, Extended-Release Analgesic Option for the Treatment of Patients with Chronic Pain

“…The efficacy of oxycodone DETERx was assessed in a phase 3, double-blind, enriched-enrollment, randomized-withdrawal study [24] in 740 opioid-naïve and opioid-experienced patients with persistent moderate-to-severe chronic low-back pain. After a screening period, patients were titrated to a stable and tolerated dose of oxycodone DETERx between 18 and 72 mg twice daily in an open-label fashion during the first 6 weeks of the study.…”

“…Patients randomized to placebo were slowly tapered off oxycodone DETERx. During the double-blind maintenance phase, 122 (63%) patients completed the 12-week treatment with oxycodone DETERx and 100 (51%) patients completed with placebo [24]. During both the titration and double-blind maintenance phases, acetaminophen (up to 2 g per day) was the only rescue medication allowed.…”

“…3) [24]. Responder rate analysis revealed significantly more patients receiving oxycodone DETERx had 30% ( p  = 0.0013) and 50% ( p  = 0.0032) improvements in pain intensity when compared with patients taking placebo [24].…”

“…3) [24]. Responder rate analysis revealed significantly more patients receiving oxycodone DETERx had 30% ( p  = 0.0013) and 50% ( p  = 0.0032) improvements in pain intensity when compared with patients taking placebo [24]. Survival analysis showed that patients treated with oxycodone DETERx remained in the study significantly longer than patients who were randomized to placebo ( p  = 0.0102) [24].…”

“…Responder rate analysis revealed significantly more patients receiving oxycodone DETERx had 30% ( p  = 0.0013) and 50% ( p  = 0.0032) improvements in pain intensity when compared with patients taking placebo [24]. Survival analysis showed that patients treated with oxycodone DETERx remained in the study significantly longer than patients who were randomized to placebo ( p  = 0.0102) [24]. In addition, Patient Global Impression of Change scores indicated that significantly more patients in the oxycodone DETERx group reported their pain to be “very much improved” and “improved” when compared with patients taking placebo ( p  < 0.0001) [24].…”