SAN ANTONIO — Opioids are often manipulated by people who are looking to gain immediate effect from extended-release formulations. These alterations constitute a major concern for physicians who might become hesitant to prescribe opioids.
An abuse-deterrent technology (ADT) was recently developed by Teva Pharmaceuticals, Inc. to prevent rapid release of hydrocodone extended-release (ER). This ADT has been shown to maintain its properties, efficacy, and tolerability for up to 12 weeks in a randomized controlled trial (RCT).
Results from a phase 3 open-label extension of this initial study were presented at the American Association of Pain Management’s Annual Meeting. Properties of abuse-deterrent hydrocodone ER were tested in 182 adults (136 of whom completed the study) experiencing moderate-to-severe back pain for more than 3 months and who had previously been enrolled in the 12 week-long RCT.
In this 22 week-long trial, study participants who were previously on placebo (n=78) were switched to hydrocodone ER (30 to 90 mg every 12 hrs); those previously on the medication were maintained on the treatment.
Safety was the trial’s primary outcome; maintenance of analgesia (ie, worst and average pain intensities) and aberrant drug behavior were secondary outcomes.
Optimal analgesia was achieved with 30 mg and 90 mg every 12 hrs in opioid-naïve and opioid-experienced patients, respectively.
Thirty six percent and 52% of study participants reported experiencing mild to moderate adverse events (ie, constipation, 7%; nausea, 6%) during dose titration and open-label treatment phases of the trial, respectively. None of the study participants experienced respiratory depression.
The researchers concluded that Hydrocodone ER was safe, well-tolerated and efficacious at doses ranging from 15 to 90 mg every 12 hrs.
This study was sponsored by Teva Branded Pharmaceutical Products R&D, Inc. (Frazer, PA). MEH conducts clinical trials sponsored by and is a consultant to Teva Pharmaceuticals; YM and RM are employees of Teva Pharmaceuticals.
- Hale ME, Ma Y, Malamut R. Phase 3 Open-Label Extension Study of Hydrocodone ER. Presented at: AAPM 2016. San Antonio, TX; September 21-25, 2016.