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Postsurgical Use Is Safe and Effective
In the review, Dr. Bekhit provided an overview of clinical studies of ER oxycodone-APAP, including results of the pivotal phase III efficacy trial that factored into the FDA’s approval.
In the double-blind, multicenter study, 303 patients undergoing unilateral first metatarsal bunionectomy were randomly assigned to receive oral ER oxycodone-APAP or placebo.
Results showed that patients in the ER oxycodone-APAP arm were less likely to require ibuprofen rescue than those given placebo (85% vs 98%), and reported lower pain intensity scores at several fixed timed intervals postoperatively.
Adverse events were infrequent; only dizziness and nausea were reported in 10% or more of patients. Other side effects occurring at rates of 1% to 10% included headache, vomiting, drowsiness, constipation, skin rash, erythema, excoriation, pruritis, skin blistering, peripheral edema, dysuria, hot flashes, elevated liver enzymes, diarrhea, dyspepsia, xerostomia, fatigue, insomnia and cough.
Pharmacokinetic studies in healthy volunteers demonstrated that the ER formulation yielded plasma concentrations and steady-state pharmacokinetics similar to that of available IR formulations.
Less Potential For Abuse
Although the FDA-approved labeling does not include abuse-deterrent language, ER oxycodone-APAP is structured to deter potential abuse and misuse. When dissolved, the tablets transform into a thick gel unsuitable for injection or snorting. Inclusion of polyethylene oxide in the formulation also makes the tablets more difficult to crush, break or dissolve.
Studies have also shown that ER oxycodone-APAP has lower subjective drug effects than the IR formulation, indicating a reduced potential for addiction.
“Adverse effects seen with this product are similar to other opioid products, but it bolsters multiple mechanisms to prevent abuse through multiple routes of administration. This makes this product advantageous when considering treatment options in patients with a history of addiction and abuse,” Dr. Reardon pointed out.
