Open Access Open Access  Restricted Access Subscription or Fee Access

Open-label study to evaluate the efficacy and safety of extended-release hydromorphone in patients with chronic neuropathic pain

Srinivas Nalamachu, MD, Donna Ruck, ARNP, Rahul Nalamasu, Sam Fasbinder, Ritvik Bansal


Objective: To assess the efficacy and safety of once-daily hydromorphone extended-release tablets (OROS [Alza Corporation, Mountain View, CA] hydromorphone ER) in patients with chronic neuropathic pain. Design: Single-center, open-label, 12-week study. Patients: Opioid-tolerant patients with chronic neuropathic pain for GTE 6 months (N = 30). Interventions: Patients were converted from previous opioid therapy to OROS hydromorphone ER using a 5:1 morphine:hydromorphone equianalgesic dosing ratio, with an initial 50 percent reduction of the calculated equianalgesic dose, titrated every 3-4 days to adequate analgesia over 2 weeks. Outcome measures: The primary efficacy measure was change from baseline to week 12 (end of study) on question #5 (“average pain”) of the Brief Pain Inventory (BPI). Secondary measures included least pain, worst pain, current pain, and sleep interference on the BPI, as well as the Pain Quality Assessment Scale (PQAS) and patient global assessment of treatment satisfaction. Results: Thirty patients were enrolled and received =1 dose of OROS hydromorphone ER, titrated to a final mean dose of 26.4 mg/d. Mean (SE) BPI change from baseline to end of study was —1.3 (0.59) for current pain (p < 0.05) and —1.8 (0.61) for worst pain (p < 0.01). Mean (SE) change from baseline was also significant for BPI scores for sleep interference (—1.7 [0.61]; p < 0.01) and PQAS scores (—24.8 [7.9], p < 0.01). The majority (81 percent) of patients were satisfied or very satisfied with treatment. The most common treatment-related adverse events were dizziness, headache, and nausea (two patients each). Conclusions: Patients with chronic neuropathic pain were safely and effectively converted to and maintained on OROS hydromorphone ER. Keywords: hydromorphone, neuropathic pain, chronic pain, efficacy, extended-release, opioid DOI:10.5055/jom.2013.0146

Full Text:



Woolf CJ: Dissecting out mechanisms responsible for peripheral neuropathic pain: Implications for diagnosis and therapy. Life Sci. 2004; 74(21): 2605-2610.

McCarberg B, Billington R: Consequences of neuropathic pain: Quality-of-life issues and associated costs. Am J Manag Care. 2006; 12(9 suppl): S263-S268.

Dworkin RH, O’Connor AB, Audette J, et al.: Recommendations for the pharmacological management of neuropathic pain: An overview and literature update. Mayo Clin Proc. 2010; 85(3 suppl): S3-S14.

Wu CL, Agarwal S, Tella PK, et al.: Morphine versus mexiletine for treatment of postamputation pain. Anesthesiology. 2008; 109(2): 289-296.

Gimbel JS, Richards P, Portenoy RK: Controlled-release oxycodone for pain in diabetic neuropathy: A randomized controlled trial. Neurology. 2003; 60(6): 927-934.

Raja SN, Haythornthwaite JA, Pappagallo M, et al.: Opioids versus antidepressants in postherpetic neuralgia: A randomized, placebo-controlled trial. Neurology. 2002; 59(7): 1015-1021.

Watson CP, Moulin D, Watt-Watson J, et al.: Controlled-release oxycodone relieves neuropathic pain: A randomized controlled trial in painful diabetic neuropathy. Pain. 2003; 105(1-2): 71-78.

Dworkin RH, O’Connor AB, Backonja M, et al.: Pharmacologic management of neuropathic pain: Evidencebased recommendations. Pain. 2007; 132(3): 237-251.

Chou R, Fanciullo GJ, Fine PG, et al.: Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009; 10(2): 113-130.

EXALGO® (hydromorphone HCl) Extended-Release Tablets (CII) [package insert]. Hazelwood, MO: Mallinckrodt Brand Pharmaceuticals, Inc., 2012.

Hale M, Khan A, Kutch M, et al.: Once-daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain. Curr Med Res Opin. 2010; 26(6): 1505-1518.

Wallace M, Rauck RL, Moulin D, et al.: Once-daily OROS hydromorphone for the management of chronic nonmalignant pain: A dose-conversion and titration study. Int J Clin Pract. 2007; 61(10): 1671-1676.

Wallace M, Rauck RL, Moulin D, et al.: Conversion from standard opioid therapy to once-daily oral extended-release hydromorphone in patients with chronic cancer pain. J Int Med Res. 2008; 36(2): 343-352.

Wallace M, Skowronski R, Khanna S, et al.: Efficacy and safety evaluation of once-daily OROS hydromorphone in patients with chronic low back pain: A pilot open-label study (DO-127). Curr Med Res Opin. 2007; 23(5): 981-989.

Cleeland CS, Ryan KM: Pain assessment: Global use of the Brief Pain Inventory. Ann Acad Med. 1994; 23(2): 129-138.

Jensen MP, Gammaitoni AR, Olaleye DO, et al.: The Pain Quality Assessment Scale: Assessment of pain quality in carpal tunnel syndrome. J Pain. 2006; 7(11): 823-832.

Gilron I, Bailey JM, Dongshen T, et al.: Morphine, gabapentin, or their combination for neuropathic pain. N Engl J Med. 2005; 352(13): 1324-1334.

Eisenberg E, McNicol ED, Carr DB: Efficacy and safety of opioid agonists in the treatment of neuropathic pain of nonmalignant origin: Systematic review and meta-analysis of randomized controlled trials. JAMA. 2005; 293(24): 3043-3052.

Galer BS, Gianas A, Jensen MP: Painful diabetic polyneuropathy: Epidemiology, pain description, and quality of life. Diabetes Res Clin Pract. 2000; 47(2): 123-128.

Binsfeld H, Szczepanski L, Waechter S, et al.: A randomized study to demonstrate noninferiority of once-daily OROS® hydromorphone with twice-daily sustained-release oxycodone for moderate to severe chronic noncancer pain. Pain Pract. 2010; 10(5): 404-415.

Hanna M, Thipphawong J; 118 Study Group: A randomized, double-blind comparison of OROS® hydromorphone and controlled- release morphine for the control of chronic cancer pain. BMC Palliat Care. 2008; 7: 17.

Fine PG, Portenoy RK; Ad Hoc Expert Panel on Evidence Review and Guidelines for Opioid Research: Establishing “best practices” for opioid rotation: Conclusions of an expert panel. J Pain Symptom Manage. 2009; 38(3): 418-425.


  • There are currently no refbacks.