Safety, Analgesic Maintenance of Hydrocodone ER Examined in Study
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 90mg every 12 hrs); those previously on the medication were maintained on the treatment.
Safety was the trial's primary outcome; maintenance of analgesia (i.e. worst and average pain intensities) and aberrant drug behavior were secondary outcomes.
Optimal analgesia was achieved with 30mg and 90mg 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 90mg 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.