OIC. Drug List. Personalized Approach to Opioid induced Constipation. Learning Objectives. Presenter Disclosure Information. Management Options

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1 1:30 2:45 pm Personalized Approach to OIC: Improving Communication and Managing Treatment SPEAKER Jeffrey A. Gudin, MD Presenter Disclosure Information The following relationships exist related to this presentation: Jeffrey A. Gudin, MD: Speakers Bureau for AstraZeneca and Salix. Advisory Board for Daiichi Sankyo. Off-Label/Investigational Discussion In accordance with pmicme policy, faculty have been asked to disclose discussion of unlabeled or unapproved use(s) of drugs or devices during the course of their presentations. Drug List Personalized Approach to Opioid induced Constipation Improving Communication and Management Options Axelopran: Investigational Bisacodyl: Dulcolax, Bisac Evac TM, Correctol Docusate sodium: Aqualax, Colace, Colace Micro Enema Husk: Fybogel, Ispagel IR Tapentadol: Nucynta Lactulose: Kristalose TM, Constulose Lubiprostone: Amitiza Methylnaltrexone: Relistor Methylcellulose: Citrucel Naloxegol: Movantik TM Naldemedine: Investigational Polyethylene Glycol: MiraLAX Prucalopride: Resolor PR Oxycodone/Naloxone: Targin, Targiniq TM, Targinact SP 333: Investigational IR=immediate release Learning Objectives Prevalence Outline prevalence, severity, and resulting burden of OIC on patients Compare and contrast the best OIC treatment options for patient specific situations Demonstrate specific and targeted questions for patients that can improve patient clinician communication about OIC Safety and Warnings Treatment Algorithm Rx Therapies OIC OTC Treatment Burden Pathophysiology HCEO $$$ OIC=opioid induced constipation; Rx=prescription; OTC=over the counter; HCEO=health care economic outcomes

2 Opioids Considered broad spectrum analgesics effective for multiple nociceptive and neuropathic pain types Approximately 250 million Rx written annually for opioids in US Controversy exists surrounding total daily dosing recommendations Many potential side effects Somnolence, nausea, itching, respiratory depression Constipation most common and most bothersome Affects quality of life and function As a Result OIC Is Increasing With the increase in opioid use, more patients are presenting with opioid induced constipation (OIC) 1 Among patients taking opioids, 40 90% have constipation and other gastrointestinal side effects which can adversely affect adherence to pain medication regimens and quality of life 2 6 Unlike other opioid related side effects, OIC is not dosedependent nor does is resolve over time 4 Instead, OIC remains a significant burden on patients and the health care system 4 Coyne KS, et al. Clinicoecon Outcomes Res. 2014;6: Nevins PH, et al. Pain Week Chey W, et al. N Engl J Med. 2014;370(25): Holzer P. Therapy. 2008;5: Bell TJ, et al. Pain Med. 2009;10: Kalso E, et al. Pain. 2004;112: Tuteja AK, et al. Neurogastroenterol Motil. 2010;22: , e96. Case Presentation 44 year old single mother of two Five year history of RA; pain was originally misdiagnosed as fibromyalgia Treated with infliximab for past 5 years Her PMH is otherwise negative Case Presentation Virginia has been referred to pain management clinic due to continuous joint pain At initial visit she reported being treated with at least 3 NSAIDs including ibuprofen 800 mg TID as well as acetaminophen 650 mg QID Pain has had significant impact on QOL and functional ability PM clinician started Virginia on IR oxycodone 5 mg up to four times per day PRN as she reported previous efficacy/success with oxycodone in the past following surgery Counseled patient about diet, hydration and exercise to maintain normal bowel function and instructed to return in four weeks for follow up RA=rheumatoid arthritis; PMH=past medical history TID=three times a day; QID=four times a day; QOL=quality of life; PM=pain management; PRN=as needed Patient Characteristics Female gender Advanced age Development of Constipation Risk Factors It is important to note, not all constipation while on opioids is OIC Dietary Considerations Dehydration Nutritional deficits Drug Regimen Opioids Anticholinergics Magnesium Calcium Antidepressants Antihistamines Medical Issues Relative immobility Nausea/vomiting Mechanical obstruction Recent hospitalizations Physiological Effects of Opioid Agonists in the GI Tract: More than Constipation Delay gut transit time Results in excessive water resorption Stimulate mucosal sensory receptors May result in pain Stimulate non propulsive motility Reduce GI secretions Tightens/constricts pylorus and ileocecal sphincters Kalso E, et al. Pain. 2004;112(3): ; Ahmedzai SH, Boland J. Clin Evid (Online). 2010;pii:2407.; Clemens KE, Klaschik EK. Ther Clin Risk Manag. 2010;6:77 82.; Wan Y CS, et al. Las Vegas, Nevada; 2013; Abstract 132. GI=gastrointestinal Camilleri M, et al. Am J Gastroenterol. 2011;106(3): ; Panchal SJ, et al. Int J Clin Pract (7):

3 Proposed Definitions of OIC What Patients Experience When OIC Occurs Proposed Definitions of OIC Camilleri, et al. (2014) 1 Gaertner, et al. (2015) 2 Consensus statement: A change when initiating opioid therapy from baseline bowel habits that is characterized by any of the following 1 : A change, when initiating opioid therapy, from baseline bowel habits, defecation patterns, and what individuals would consider as abnormal that is characterized by any of the following 2 : Straining Hard Stools Incomplete Evacuation 1. Reduced BM frequency 1. Reduced frequency of SBMs (in contrast to induced BMs) 2. Development or worsening of straining to pass BMs Bloating Pain 3. A sense of incomplete rectal evacuation 4. Harder stool consistency Infrequent Stools BM=bowel movement; SBM=spontaneous bowel movement 1 Camilleri M, et al. Neurogastroenterol Motil. 2014;26(10): Gaertner J, et al. J Clin Gastroenterol. 2015;49(1):9 16. Severe Potential Consequences of OIC OIC Often Underdiagnosed Fecal Impaction Overflow Incontinence Bowel Ischemia Patient complaints regarding constipation may vary from one individual to the next Clinical measures of constipation, the number of bowel movements/week, do not often correlate with patients perception of what is regular Patients may deny yet meet clinical criteria for constipation Patients may neglect or be embarrassed to discuss their constipation issues Perforation Camilleri M, et al. Am J Gastroenterol. 2011;106(3): ; Holzer P. Expert Opin Investig Drugs. 2007;16(2): Assessing symptoms by talking to patients is the most efficient and cost effective way to determine the presence of OIC Coffin B, et al. Expert Rev Gastroenterol Hepatol. 2011;5(5): OIC Can Compromise Pain Management Burden and Cost of OIC Patients missed, decreased, or stopped opioids.. to get relief from opioid induced AEs 35% OIC has been found to represent a significant economic cost burden, including impact on patient s QOL and productivity to avoid opioid induced AEs 28% to make it easier to have a bowel movement 33% 0% 5% 10% 15% 20% 25% 30% 35% 92% of patients who decreased or stopped opioids experienced increased pain AEs=adverse events Bell TJ, et al. Pain Med. 2009;10: Wan Y, et al Am Health Drug Benefits. 2015; 8(2):

4 $25,000 $20,000 $15,000 $10,000 $5,000 $ $23,631 ±$67,209 Cost Burden $12,652 ±$19,717 With OIC Without OIC $16,923 $16,000 $14,437 ±$38,191 $11,117 ±$22,897 ±$25,690 ±$19,525 Nonelderly Elderly Long term care Recent study demonstrated patients with OIC had significantly more hospital admissions and longer inpatient stays than patients without OIC. The group with OIC had significantly higher costs per patient than those without. Wan Y, et al. Accessed at term_opioid_users_with_non_cancer_pain. Accessed November 9, Work Productivity and Overall Patient Quality of Life Worse 70 Score (%) Better * Work time missed *P<.05, OIC vs no OIC Scores on Domains of Work Productivity and Activity Impairment Questionnaire * 44.9 OIC 33.1 Impairment while working No OIC * 47.7 Overall work impairment Bell TJ, et al. J Opioid Manag. 2009;5: * Activity impairment Findings from a national health and wellness study demonstrated that, when compared with individuals without OIC, those individuals with OIC reported: Higher percentage of work time missed Greater impairment while working Greater overall work impairment Greater activity impairment The Patient History: Asking the Right Questions Previous bowel pattern prior to starting opioids Current pattern while taking opioids Stool frequency, consistency, and size Degree of straining during defecation History of delayed defecation Fiber intake Fluid intake Fruit and vegetable intake Exercise levels physical activity Laxative use (frequency and types) Other medications (anticholinergics, calcium channel antagonists, iron supplements, calcium supplements) Summary: PRO Assessment Tool Use in OIC Drug Development Assessment Tool Drug Development Program(s) in OIC Patients 1 PAC SYM 1 PR oxycodone/naloxone PO Methylnaltrexone SC Prucalopride PO a,2 Alvimopan PO OIC program discontinued b,3,4 Stool Symptom Screener 5 None identified PAC QOL 1 Methylnaltrexone SC Prucalopride PO a,2 Alvimopan PO OIC program discontinued b,3,4 BFI 1 PR oxycodone/naloxone PO BF Diary 6 IR tapentadol PO a Approved in several countries (but not in the United States). b OIC program discontinued due to cardiovascular safety concerns. 1 Gaertner J, et al. J Clin Gastroenterol. 2015;49(1): Shire. gastrointestinal/resolor. Accessed March 6, 2015.; 3 Irving G, et al. J Pain. 2011;12(2): ; 4 Sprawls KS, et al. Drugs in Development for Opioid Induced Constipation. Published March 7, Coyne KS, et al. [Published online September 18, 2014]. Patient. 6 Camilleri M, et al. Am J Gastroenterol. 2011;106(3): Tools for Patients Bowel Function Index Three item assessment Assesses: Ease of BM BM completeness Overall assessment Score is mean of 3 items Selected by AAPM consensus panel to be a good choice as a validated tool 1 AAPM has convened a panel of experts for a consensus meeting to develop and publish guidelines that identify assessment tools and outcome measures that are most effective and practical for characterizing OIC severity, as well as corresponding objective thresholds that should prompt the clinical decision to prescribe new OICspecific prescription drug therapies. AAPM=American Academy of Pain Medicine 1 Webster LR. Pain Med. 2015;16 Suppl 1:S16-21.

5 Current Therapeutic Approaches Non Pharmacologic Constipation Therapies Hydration No real evidence 1 Dietary modification Fruits, juices Bran, fiber, psyllium Caffeine Fried foods Exercise Bowel hygiene Obey the urge Manual maneuvers Enema Digital stim Positional Squatty potty 1 Leung L, et al. J Am Board Fam Med. 2011;24(4): OTC Options: Current Therapy Falls Short OIC treatment is currently dominated by the use of laxatives, which are only partially effective and cause complications of their own 1 Appropriate use of laxatives requires an understanding of how different agents work, their effectiveness, and associated risk Type Mechanism of Action Examples Side effects/complications Laxatives do not prevent or treat the cause of OIC activation of mu opioid receptors in the gastrointestinal tract 1,3 5 Laxatives are only partially effective for OIC, providing relief for fewer than 50% of patients 50% of the time 2 Laxatives pose serious risks with prolonged, frequent or excessive use Bulk laxatives Osmotic laxatives Stool softeners Stimulants Dietary fiber; causes water retention in the colon and increases stool bulk Salt content retains fluid retention and increases intestinal secretions Decrease surface tension to lubricate and soften fecal matter Increase colonic motility and electrolyte transport; stimulate fluid secretion Psyllium, husk, methylcellulose Sorbitol, lactulose, polyethylene glycol, magnesium citrate Docusate sodium Senna, cascara, bisacodyl Increased gas; risk for bowel obstruction in patients with strictures Electrolyte imbalances; increased gas, nausea, and dehydration Require adequate fluid intake, useless in patients with compromised bowel motility Electrolyte imbalances; abdominal pain, nausea, and colonic dysmotility 1 Thomas J. N Engl J Med. 2008;358: Pappagallo M. Am J Surg. 2001;182:Suppl. S11 S18. 3 Miralax Product Label, Schering Plough Healthcare Products. 4 Metamucil Product Label, Proctor and Gamble. Brenner D, et al. Pain Medicine News. September 2013.; Schafer DC, et al. Am Fam Physician. 1998;58(4): ; Benyamin R, et al. Pain Physician. 2008;11(2 suppl):s Current Approved Therapeutic Options for Opioid Induced Constipation New and Emerging Treatments in OIC Agent Mechanism of Action Mode of Administration Frequency of Dosing Lubiprostone Chloride channel activator Oral Twice daily Clinical Recommendations Adverse Event Profile Capsules should be swallowed whole and should not be broken apart or chewed. Take with food and water. May be used concomitantly for length of opioid treatment. Effectiveness of use in patients taking methadone has not been established. In most common adverse events in clinical trials were: nausea (19.8%), diarrhea (9.7%), abdominal distention (6.9%), headache (6.9%), abdominal pain (5.2%). Amitiza (lubiprostone capsules). Full Prescribing Information, Sucampo Pharma Americas, LLC, Bethesda, MD and Takeda Pharmaceuticals America, Inc., Deerfield, IL, 2013.; Lacy BE, Levy LC. J Clin Gastroenterol. 2007;41(4): ; Cryer B, et al. Pain Med. 2014;15(11):

6 Current Approved Therapeutic Options for Opioid Induced Constipation Current Approved Therapeutic Options for Opioid Induced Constipation Agent Methylnaltrexone Agent Naloxegol Mechanism of Action Peripheral mu opioid receptor antagonist (PAMORA) Mechanism of Action Peripheral mu opioid receptor antagonist (PAMORA) Mode of Administration Subcutaneous. When selecting an injection site, choose from the abdomen, thighs, or upper arms. Rotate injection sites. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks. Mode of Administration Oral Frequency of Dosing Once daily Frequency of Dosing Once daily Clinical Recommendations Discontinue maintenance laxative therapy prior to use. Need close proximity to toilet once administered. Use of methylnaltrexone beyond four months has not been studied. Monitor for signs of opioid withdrawal. Discontinue if treatment with opioid pain medication is also discontinued. Adverse Event Profile In most common adverse events in clinical trials were: abdominal pain (28.5%), flatulence (13.3%), nausea (11.5%), dizziness (7.3%), diarrhea (5.5%). Clinical Recommendations Take on an empty stomach at least 1 hour prior to meal or 2 hours after the meal. Swallow tablets whole. Do not crush or chew. Avoid consumption of grapefruit or grapefruit juice. Discontinue if treatment with opioid pain medication is also discontinued. Adverse Event Profile In most common adverse events in clinical trials were: abdominal pain (21%), diarrhea (9%), nausea (8%), flatulence (6%), vomiting (5%), headache (4%), and hyperhidrosis (3%). Relistor (methylnaltrexone bromide subcutaneous injection). Full Prescribing Information, Salix Pharmaceuticals, Inc., Raleigh, NC, 2014.; Michna E, et al. J Pain. 2011;12(5): Movantik (naloxegol). Full Prescribing Information, AstraZeneca Pharmaceuticals LP, Wilmington, DE, 2015.; Chey WD, et al. N Engl J Med. 2014;370(25): PAMORAs Opioid antagonists that bind to mu opioid receptors in the gut, displacing or preventing opioids from binding Methylnaltrexone: First approved in 2008 for opioidinduced constipation in patients with advanced illness receiving palliative care; indication expanded in 2014 to include OIC in noncancer patients. Currently administered as a subcutaneous injection Naloxegol approved in 2014 for OIC in adult patients with noncancer pain. First PAMORA oral tablet approved for OIC Others in development PAMORA=Peripherally Acting Mu Opioid Receptor Antagonists Patients with >3 SBMs During 4 week Period, % Methylnaltrexone: Peripherally Acting mu Receptor Antagonist Response Rates in the mitt Population 59 Methlynaltrexone 12 mg QD (n=150) a 38 Placebo (n=162) 4 week, double blind, randomized, placebo controlled, phase 3 clinical trial Primary Endpoint: % patients with >3 in SBMs per week, during 4 week period SBM, defined as a BM with no laxative use within prior 24 hours.; a P<.001 versus placebo; QD=once daily. N=312 patients with chronic noncancer pain.; mitt=modified intent to treat population, included all randomized patients who received 1 dose of double blind study medication Drugs@FDA: Accessed April 6, Naloxegol: Peripherally Acting mu Receptor Antagonist Placebo Naloxegol, 12.5 mg Naloxegol, 25 mg 40.8 a Response Rates in the ITT Population a a 39.7 Two 12 week, double blind, randomized, placebo controlled, phase 3 clinical trials Primary Endpoint: 12 week response rate ( 3 SBM/week and increase over baseline of 1 SBM for 9 of 12 weeks and 3 of the final 4 weeks) SBM, defined as a BM with no laxative use within prior 24 hours; a P<0.05 vs placebo in each study; N=652, Study 04; N=700, Study 05.; ITT=intention to treat Chey WD, et al. N Engl J Med. 2014;370(25): Chlorine Channel Activator: Lubiprostone Works as an agonist at the chloride channel Approved for IBS c and OIC Doses of 24 mcg twice daily for treatment of OIC in adults Unlike many laxative products, lubiprostone does not show signs of tolerance, dependency, or altered serum electrolyte concentration IBS c=irritable bowel syndrome and constipation

7 Lubiprostone Chloride Channel Activator OIC Therapies in Development Mean Change from Baseline in SBM Frequency P = Placebo (N = 208) Lubiprostone (n = 210) P = Week 8 Week 12 Overall No. of Observations 2.6 P =.004 Primary endpoint: change at 8 weeks from baseline weekly frequency ASBMs (bowel movements without the use of a laxative or stool softeners with the last 2 hours) Cryer B, et al. Pain Med. 2014;15(11): Methylnaltrexone oral formulation Oral peripherally mu opioid receptor antagonist Phase 3 studies met endpoints Naldemedine Oral peripherally selective mu opioid receptor antagonist Phase 3 trial underway Prucalopride* Full agonist of 5 HT4receptors Ongoing phase 2 studies. Currently approved for chronic constipation in Europe and Canada Axelopran Oral peripherally selective mu opioid receptor antagonist Phase 2 trial underway SP 333 Oral second generation uroguanylin analog Phase 2 trial underway *Prucalopride is not approved by the FDA for use in the United States Wanami M, et al. A review of peripherally acting mu opioid receptor antagonists. February 1, journal/news/clinical/clinical pharmacology/reviewperipherally acting mu opioid receptor?page=full. Accessed November 12, Clinicaltrials.gov accessed November, OIC Improvements Desired by Patients A single additional BM per week may serve as the minimal clinically important difference for patients with OIC Patients (%) Most Commonly Desired Improvements N=513 Have 1 more BM per week 96.0% Be able to have a BM without pain 87.9% Be able to have soft stool that is not loose or watery 87.1% Not experience rectal straining due to constipation 83.4% Feel less bloated 83.0% Be more comfortable using opioid medication without fear of being constipated 82.1% Worry less about being able to have a BM 80.5% Have less pain in stomach area 80.3% Epstein RS, et al. Adv Ther. 2014;31(12): % 90.0% 80.0% 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% Patients and HCPs Have Different Perceptions of Satisfaction with Constipation Treatment Very satisfied A little satisfied A little dissatisfied Very dissatisfied 23.2% 25.7% 28.4% 14.9% 53.1% 100.0% 90.0% 80.0% 70.0% 60.0% 50.0% 40.0% 10.7% 29.3% 44.0% 69.3% 30.0% 22.7% 28.9% 20.0% 10.0% 16.0% 26.7% 3.1% 1.3% 0.0% Patient (n = 194) HCP (n = 75) Patient (n = 194) HCP (n = 75) Baseline Week 24 Datto C, et al. Poster, American Academy of Pain Medicine 31 st Annual Meeting, March 19 22, National Harbor, MD. 2.7% Keeping the Dialogue Open When discussing this topic, health care providers need to be open and empathetic Offer reasonable options that will work with the patient s daily routine When the first options do not work, encourage the patients to continue to try other options until one is successful Strategies to Discuss with the Patient Reducing opioid dose generally not effective Opioid rotation changing to a reduced dose of a new opioid Patients are usually reluctant to change or reduce opioids if there is another way to manage the constipation

8 Strategies to Effectively Communicate With Patients about OIC If patients are unable to communicate directly, the clinician should discuss the issue with the caregiver The discussion prior to commencing opioid therapy should include a plan for follow up communication, whether in the office or over the telephone, to assess the response to the medication During the discussion, listen for clues that may be more representative of OIC than frequency, including cramping, hard small stools, and significant straining Evaluate any reports of diarrhea, which could result from stool leaking around a fecal impaction, rule out impaction and obstruction, and treat any secondary contributors to the constipation Consider prophylactic bowel management PCP Pain Specialist Collaboration in Patient Centered Care Pain Specialist Improved Patient Outcomes Primary Care Safety / Warnings Remember to Ask About Bowel Function in Every Patient Prescribed Opioids There is no tool that replaces communication with the patient! Constipation can be associated with morbidity Treatment of constipation can be associated with morbidity Always assess for possibility of bowel obstruction or perforation Understand adverse effects and drug:drug interactions of laxative therapies Proposed Treatment Algorithm Brenner DM, Chey WD. Am J Gastroenterol Suppl. 2014;2:38 46 Summary Opioid analgesics are a mainstay treatment in pain management Constipation is one of the most common and troubling symptoms related to opioids; does not usually improve over time Assessment is important as patients may not convey the severity Stool softeners, laxatives and dietary modifications are often not effective at controlling opioid induced constipation Newer prescriptive agents are available that promote motility and lubrication of stool to improve the symptoms associated with opioid induced constipation

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