Pharmacy & Therapeutics - October 2008 - (Page 583)

DRUG FORECAST compared with placebo.19,25 At present, no head-to-head studies have compared alvimopan with other agents. ileus into multimodal protocols. Contemp Surg 2006(Suppl):1–24. Foss JF, Fisher DM, Schmith VD. Pharmacokinetics of alvimopan and its metabolite in healthy volunteers and patients in postoperative ileus trials. Clin Pharmacol Ther 2008;83(5):770–776. Büchler MW, Seiler CM, Monson JR, et al. Clinical trial: Alvimopan for the management of postoperative ileus after abdominal surger y: Results of an international randomized, double-blind, multicentre, placebo-controlled clinical study. Aliment Pharmacol Ther 2008;28 (3):312– 325. Alvimopan (Entereg), package insert. Exton, PA, and Research Triangle Park, NC: Adolor/GlaxoSmithKline; 2008. FDA. Meeting of the Gastrointestinal Drugs Advisory Committee to Evaluate Entereg (Alvimopan) for the Acceleration of Recover y Time to Upper and Lower Gastrointestinal Recovery Following Partial Large or Small Bowel Resection Surgery with Primary Anastomosis. January 23, 2008. Available at: www.fda. gov/ohrms/dockets/ac/08/briefing/ 2008-4336b1-01-FDA.pdf. Accessed July 28, 2008. Herzog TJ, Coleman RL, Guerrieri JP Jr, et al. A double-blind, randomized, placebo-controlled phase III study of the safety of alvimopan in patients who undergo simple total abdominal hysterectomy. Am J Obstet Gynecol 2006;195(2): 445–453. Wolff BG, Viscusi ER, Delaney CP, et al. Patterns of gastrointestinal recovery after bowel resection and total abdominal hysterectomy: Pooled results from the placebo arms of alvimopan phase III North American clinical trials. J Am Coll Surg 2007;205(1):43–51. Delaney CP, Weese JL, Hyman NH, et al. Postoperative Ileus Study Group. Phase III trial of alvimopan, a novel, peripherally acting, mu opioid antagonist, for postoperative ileus after major abdominal surgery. Dis Colon Rectum 2005;48(6): 1114–1125. Viscusi ER, Goldstein S, Witkowski T, et al. Alvimopan, a peripherally acting mu-opioid receptor antagonist, compared with placebo in postoperative ileus after major abdominal surgery: Results of a randomized, double-blind, controlled study. Surg Endosc 2006;20(2):64–70. Wolff BG, Michelassi F, Gerkin TM, et al. Alvimopan Postoperative Ileus Study Group. Alvimopan, a novel, peripherally acting mu opioid antagonist: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial of major abdominal surger y and postoperative ileus. Ann Surg 2004;240(4):728–734. Paulson DM, Kennedy DT, Donovick RA, et al. Alvimopan: An oral, peripherally acting, mu-opioid receptor antagonist for the treatment of opioid-induced bowel dysfunction: A 21-day treatment-randomized clinical trial. J Pain 2005;6:184–192. Webster L, Jansen J, Peppin JB, et al. Alvimopan, a peripherally acting muopioid receptor (PAM-OR) antagonist for the treatment of opioid-induced bowel dysfunction: Results from a randomized, double-blind, placebo-controlled, dosefinding study in subjects taking opioids for chronic non-cancer pain. Pain 2008; 137:428–440. Taguchi A, Sharma W, Saleem RM, et al. Selective postoperative inhibition of gastrointestinal opioid receptors. N Engl J Med 2001;345(13):935–940. GSK and Adolor announce preliminary results from Phase 3 safety study of Alvimopan (Entereg/Entrareg). April 9, 2007. Available at: www.gsk-us.com. Accessed July 29, 2008. Drug approved by FDA. Drug name: Entereg (alvimopan). Available at: www. center watch.com. Accessed July 28, 2008. Kraft MD. Emerging pharmacologic options for treating postoperative ileus. Am J Health Syst Pharm 2007;64:13–20. Litkouhi B, Muto MG. Postoperative ileus. In: Rose BD (ed). Up-To-Date. Waltham, MA: 2006. Available at: www. uptodate.com. Accessed July 29, 2008. Cheape JD, Wexner SD, James K, Jagelman DG. Does metoclopramide reduce the length of ileus after colorectal surgery? A prospective randomized trial. Dis Colon Rectum 1991;34:437–441. Jepsen S, Klaerke A, Nielsen PH, Simonsen O. Negative effect of metoclopramide in postoperative adynamic ileus: A prospective, randomized, double blind study. Br J Surg 1986;73:290–291. Bonacini M, Quiason S, Reynolds M, et al. Effect of intravenous erythromycin on postoperative ileus. Am J Gastro enterol 1993;88:208–211. Hallerback B, Carlsen E, Carlsson K, et al. Beta-adrenoceptor blockade in the treatment of postoperative adynamic ileus. Scand J Gastroenterol 1987;22:149– 155. Neostigmine bromide/neostigmine methylsulfate. In: McEvoy GK, ed. American Hospital Formulary Service Drug Information 2007. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1245–1247. Drug Trials and Comparisons. Intravenous methylnaltrexone fails in phase 3 trial. Wyeth/Progenics, March 12, 2008. Available at: www.ptcommunity.com/ Daily/DailyDetail.cfm?chosen=65486. Accessed September 8, 2008. Shakespear B, Fox ER, eds. New Drug Bulletin: Alvimopan (Entereg). University of Utah Hospitals & Clinics, July 14, 2008. Available at: http://uuhsc.utah. edu. Accessed September 8, 2008. CardinalHealth inpatient cost data. Available at: https://pd.cardinal.com and www.cardinal.com. Accessed August 5, 2008. I 4. COST Alvimopan 12-mg capsules are available in a unit package of 30. As of July 2008, the average wholesale price (AWP) for 30 tablets was $2,250, or approximately $75 per capsule. A full course of therapy, for up to seven days for a maximum of 15 doses, was $1,125.26 This cost may vary, depending on the acquisition cost for each hospital. The AWPs of other therapeutic options used for the management of POI are listed in Table 2 (see page 582).27 5. 15. 16. 6. 7. 17. 18. 19. CONCLUSION Alvimopan reverses opioid-induced slowing of GI transit time and constipation without antagonizing the analgesic effect of opioid analgesics or precipitating withdrawal in opioid-dependent patients. It has been studied in patients at high risk for POI and patients with OBD. With the recent FDA approval of alvimopan, many P&T committees will be impelled to evaluate it for inclusion on formularies. With the REMS and EASE programs in place, establishing criteria for the safe, appropriate, and cost-effective use of alvimopan will be imperative. Criteria for use might call for restricting alvimopan use in patients undergoing abdominal surgeries associated with a higher risk of POI and for treating OBD in patients receiving chronic opioid therapy. The most important concern is the drug’s safety profile. Because cardiovascular safety remains a concern, restrictions might apply to patients with cardiovascular disease. Although adding alvimopan might increase pharmacy budgets, substantial cost savings could be realized from the reductions in hospital LOS observed in some clinical trials. 20. 8. 21. 9. 22. 23. 10. 24. 11. 25. 12. REFERENCES 1. Goldstein JL, Matuszewski KA, Delaney CP. Inpatient economic burden of postoperative ileus associated with abdominal surgery in the United States. P&T 2007; 32(2):82–90. 2. Delaney CP. Clinical perspective on postoperative ileus and the effect of opiates. Neurogastroenterol Motil 2004;16(Suppl 2):61–66. 3. Wolff BG, Leslie JB, Saclarides TJ, et al. Integrating new agents for postoperative 26. 27. 13. 14. Vol. 33 No. 10 • October 2008 • P&T® 583 http://www.gsk-us.com http://www.centerwatch.com http://www.centerwatch.com http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4336b1-01-FDA.pdf http://www.uptodate.com http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4336b1-01-FDA.pdf http://www.uptodate.com http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4336b1-01-FDA.pdf http://www.ptcommunity.com/Daily/DailyDetail.cfm?chosen=65486 http://www.ptcommunity.com/Daily/DailyDetail.cfm?chosen=65486 http://uuhsc.utah.edu http://uuhsc.utah.edu https://pd.cardinal.com http://www.cardinal.com

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Pharmacy & Therapeutics - October 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Medical Management of Parkinson’s Disease Why Is Health Care Regulation So Complex? The Next President’s Prescription for Action on Drugs Trends in Managing Multiple Sclerosis Product Profiler: Sancuso®

Pharmacy & Therapeutics - October 2008

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