Presented at the 2013 AAPM Annual Meeting « Back

Clinical Utility of Once-Daily OROS® Hydromorphone Extended-Release (Hydromorphone ER) Compared with Other Strong Extended-Release Opioids

Srinivas Nalamachu, MD, nalamachu@yahoo.com¹, Jeffrey Patrick, PharmD², (1) International Clinical Research Institute, Inc., Overland Park, Kansas,(2) Mallinckrodt Inc., Hazelwood, Missouri

Introduction: OROS® hydromorphone ER (hydromorphone ER) was introduced as a once-daily hydromorphone preparation in 2010 for use in patients with moderate to severe chronic pain. However, data regarding actual clinical utility and dosing have not been reported previously. Materials and Methods: IMS postmarketing data from December 2010 to November 2011 were examined for dosing of hydromorphone ER, oxymorphone extended-release (oxymorphone ER), and oxycodone controlled-release (oxycodone CR). Dosing and safety data were pooled from 13 controlled and uncontrolled hydromorphone ER clinical trials in patients with chronic cancer and non-cancer pain. Institutional review board approval and written informed consent were obtained for all studies. Results: Mean doses of hydromorphone ER, oxymorphone ER and oxycodone CR in clinical use were 21.4 mg (107 mg morphine equivalent, ME), 63.7 mg (191 mg ME), and 102.5 mg (205 mg ME), respectively. Limitations of this data set include limited time of market availability, physician and patient access, implications of incomplete cross-tolerance, and potentially other factors. Conclusions: Doses of hydromorphone ER in clinical practice were nearly 50% lower than those of oxymorphone ER and oxycodone CR (converted to morphine equivalents) and substantially less than the 57.4 mg mean reported in those clinical trials with no protocol-designed dose capitation. Clinical trial data support safety of hydromorphone ER at doses from 12 to 96 mg with appropriate patient selection, conversion, and titration (Table). Thirty-two milligrams of OROS® hydromorphone ER has demonstrated clinical relevance by prescription patterns, and represents the median dose for patients in the pivotal clinical trial.

Funding: Technical editorial and medical writing assistance was provided by Synchrony Medical Communications, LLC, West Chester, PA. This support was funded by Mallinckrodt Inc., a Covidien company, Hazelwood MO.