Novel oxycodone abuse-deterrent formula effective for chronic pain
Oxycodone DETERx ER, an extended-release, abuse-deterrent drug, safely and effectively managed chronic pain in patients with poorly managed pain previously treated with immediate-release oxycodone, according to data presented at PAINWeek.
“Converting patients previously taking immediate-release [IR] opioid medications to extended-release [ER] products is common clinical practice; however, there is little to no scientific literature available that specifically examines it,” Diana Meske, study researcher with Collegium Pharmaceutical, told Healio Internal Medicine. “Collegium believes that it is important to provide clinicians with as much relevant data when considering treatment options, or changes to treatment, for their patients and thus sought to complete a post-hoc analysis of the results from our phase 3 efficacy and safety study used to support approval of [oxycodone DETERx ER (Xtampza ER)].”
Meske and colleagues analyzed 44 patients with chronic low back pain from the phase 3 trial to determine whether participants with poorly managed pain who were previously on IR oxycodone could successfully convert to oxycodone DETERx ER, abuse-deterrent formula of ER oxycodone.
From baseline to week 12, data revealed a statistically significant difference in average pain intensity that favored oxycodone DETERx ER (least squares mean difference = −1.94; P = .002). In addition, among participants receiving oxycodone DETERx ER, there were statistically significant differences in patient global impression of change, percent of participants withdrawing from the trial and responder analysis (≥ 30% or ≥ 50% improvement; P < .005 for each). Less rescue medication was used in the oxycodone DETERx ER group. Adverse event profiles were similar between groups.
“Our data support that some patients on an IR oxycodone regimen can be switched to a dose of Xtampza ER to effectively and safely control their pain,” Meske said. “This is important as pain practice guidelines, including those from the American Pain Society, American Academy of Pain Medicine and the Centers for Disease Control [and Prevention], recognize the potential benefit of switching patients with chronic pain, who do not respond to non-drug or non-opioid therapies, from IR to ER opioids. Of course, clinical judgement of healthcare providers is required to identify the appropriate patients and clinical scenario most suitable for such transitions.” – by Alaina Tedesco
Meske D, et al. Converting patients with chronic pain from immediate-release oxycodone to Xtampza ER, an extended-release, abuse-deterrent formulation. Presented at: PAINWeek 2017; Sept. 5-9; Las Vegas.
Disclosure: Healio Internal Medicine was unable to confirm relevant financial disclosures at the time of publication.