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Shionogi Inc. and Purdue Pharma L.P. to Present Data from Naldemedine Studies at PAINWeek® 2017 Annual Conference

2017年09月06日 PM09:02
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OSAKA, Japan & FLORHAM PARK, N.J. & STAMFORD, Conn.

Purdue Pharma L.P. and Shionogi Inc. will present results from four research studies of naldemedine during the 11th Annual PAINWeek® Conference, taking place September 5-9, 2017 in Las Vegas.

The U.S. Food and Drug Administration (FDA) approved Symproic as a once-daily oral tablet which functions as a peripherally acting mu-opioid receptor antagonist medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

Symproic is currently a Schedule II controlled substance because it is structurally related to naltrexone. Shionogi Inc. submitted a petition for the descheduling of Symproic, or removal of the controlled substance classification, to the U.S. Drug Enforcement Administration (DEA), which is currently under evaluation. Symproic will be jointly launched and commercialized in the U.S. by Shionogi Inc. and Purdue Pharma.

The posters will be available for viewing beginning September 6 at 3:30 p.m. PDT. Authors will be available at the PAINWeek Poster Session and Reception Thursday, September 7, at 6:30-8:30 p.m. PDT.

         
Title   Authors   Poster #
Subject Global Satisfaction Score to Assess Overall Effect of Naldemedine Compared with Placebo on Constipation and Abdominal Symptoms in Subjects with Chronic Non-cancer Pain and Opioid-Induced Constipation   Tack J, Camilleri M, Cai B, Yamada T, Arjona Ferreira JC   10
Effect of Treatment with Naldemedine on the Patient Assessment of Constipation Symptoms and the Patient Assessment of Constipation Quality of Life Questionnaires in Patients with Chronic Non-Cancer Pain and Opioid-Induced Constipation   Camilleri M, Tack J, Yamada T, Cai B, Arjona Ferreira JC   9
Effects of Naldemedine, a Peripherally Acting µ-Opioid Receptor Antagonist, on Inhibition of Large Intestinal Transit Induced by Morphine in Rodent Models   Kanemasa T, Ono H, Nakamura A, Koike K, Morioka Y, Hasegawa M   109
A Literature Review of the Quality of Life Burden of Opioid-Induced Constipation   Kennedy-Martin T, Krauter E, Cai B, Munro V, Conway P   23
   

Please see Important Safety Information, including Warnings & Precautions and Adverse Reactions below.

About Opioid-Induced Constipation

Constipation is one of the most commonly reported side effects associated with opioid treatment, including among patients with chronic non-cancer pain.1 When opioids bind to specific proteins called mu-opioid receptors in the gastrointestinal (GI) tract, constipation may occur. Opioid-induced constipation (OIC) is a result of increased fluid absorption and reduced GI motility due to opioid receptor binding in the GI tract. OIC is defined as a change in bowel habits that is characterized by any of the following after initiating opioid therapy: reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, or harder stool consistency.2 In patients receiving opioid therapy for chronic non-cancer pain, the prevalence of OIC ranges from approximately 40-50 percent.3-6

INDICATION

Symproic® (naldemedine) CII is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

DOSING AND ADMINISTRATION

Symproic comes as a 0.2 mg once-daily oral tablet and may be taken at any time of day, with or without food and with or without laxatives. Alteration of analgesic dosing regimen prior to initiating Symproic is not required. Patients receiving opioids for less than 4 weeks may be less responsive to Symproic. Treatment with Symproic should be discontinued if treatment with the opioid medicine is also discontinued.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent obstruction, due to the potential for GI perforation.
  • Patients with a history of a hypersensitivity reaction to Symproic. Reactions have included bronchospasm and rash.

WARNINGS AND PRECAUTIONS

Cases of GI perforation have been reported with use of another peripherally acting opioid antagonist in patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract. Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue if this symptom develops.

Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, increased lacrimation, hot flush/flushing, pyrexia, sneezing, feeling cold, abdominal pain, diarrhea, nausea, and vomiting have occurred in patients treated with Symproic.

Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. Take into account the overall risk-benefit profile when using Symproic in such patients. Monitor for symptoms of opioid withdrawal in such patients.

DRUG INTERACTIONS

Avoid use with strong CYP3A inducers (e.g., rifampin) because they may reduce the efficacy of Symproic.

Use with moderate (e.g., fluconazole) and strong (e.g., itraconazole) CYP3A inhibitors and P-glycoprotein inhibitors (e.g., cyclosporine) may increase Symproic concentrations. Monitor for potential adverse reactions.

Avoid use of Symproic with another opioid antagonist due to potential for additive effect and increased risk of opioid withdrawal.

USE IN SPECIFIC POPULATIONS

Symproic crosses the placenta and may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier. Symproic should be used during pregnancy only if the potential benefit justifies the potential risk. Because of the potential for serious adverse reactions, including opioid withdrawal in breastfed infants, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Avoid use in patients with severe hepatic impairment. No dose adjustment of Symproic is required in patients with mild or moderate hepatic impairment.

ADVERSE REACTIONS

The most common adverse reactions with Symproic as compared to placebo in clinical trials were: abdominal pain (8% vs 2%), diarrhea (7% vs 2%), nausea (4% vs 2%), and gastroenteritis (2% vs 1%).

In pooled Studies 1 and 2, the incidence of adverse reactions of opioid withdrawal was 1% (8/542) for Symproic and 1% (3/546) for placebo. In Study 3 (52-week data), the incidence was 3% (20/621) for Symproic and 1% (9/619) for placebo.

To report SUSPECTED ADVERSE REACTIONS, contact Shionogi at 1-800-849-9707 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see complete U.S. Full Prescribing Information including Medication Guide by clicking here.

About Shionogi

Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and well-being of the patients we serve.” Shionogi’s research and development currently target two therapeutic areas: infectious diseases and pain/CNS disorders. For over 50 years, Shionogi has developed and commercialized innovative oral and parenteral anti-infectives. In addition, Shionogi is engaged in new research areas, such as obesity/geriatric metabolic disease and oncology/immunology. Contributing to the health and quality of life of patients around the world through development in these therapeutic areas is Shionogi’s primary goal. For more details, please visit www.shionogi.co.jp/en/. For more information on Shionogi Inc., the U.S.-based subsidiary of Shionogi & Co., Ltd., headquartered in Florham Park, NJ, USA, please visit www.shionogi.com . For more information on Shionogi Ltd., the UK-based subsidiary of Shionogi & Co. Ltd., headquartered in London, England, please visit www.shionogi.eu.

About Purdue Pharma L.P.

Purdue Pharma L.P. is a privately held pharmaceutical company headquartered in Stamford, Conn. Purdue Pharma is part of a network of independent associated companies dedicated to providing patients and providers with innovative medicines. The company’s leadership and employees are committed to serving healthcare professionals, patients and caregivers quality products and educational resources that make a positive impact on healthcare — and on lives. For more information, please visit www.purduepharma.com.

REFERENCES

1Sehgal N, Colson J, Smith HS. Chronic pain treatment with opioid analgesics: benefits versus harms of long-term therapy. Expert Rev Neurother. 2013;13:1201-1220.

2Camilleri M, Drossman DA, Becker G, Webster LR, Davies AN, Mawe GM. Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Neurogastroenterol Motil. 2014;26: 1386-1395.

3Kalso E, Edwards JE, Moore RA, McQuay HJ. Opioids in chronic noncancer pain: systematic review of efficacy and safety. Pain. 2004;112:372–80.

4Cook SF, Lanza L, Zhou X, et al. Gastrointestinal side effects in chronic opioid users: results from a population based survey. Aliment Pharmacol Ther. 2008;27(12):1224-1232.

5Brown RT, Zuelsdorff M, Fleming M. Adverse effects and cognitive function among primary care patients taking opioids for chronic nonmalignant pain. J Opioid Manag. 2006;2(3):137–146.

6Tuteja AK, Biskupiak J, Stoddard GJ, Lipman AG. Opioid induced bowel disorders and narcotic bowel syndrome in patients with chronic non-cancer pain. Neurogastroenterol Motil. 2010;22(4):424-430.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170906005354/en/

CONTACT

Media:
Shionogi Inc.
Lindsay N. Bohlander, PharmD
Office:
+1-973-307-3718
Mobile: +1-973-665-4245
Lindsay.bohlander@shionogi.com
or
Purdue
Pharma L.P.
Danielle Lewis
Office: +1-203-588-7653
Mobile:
+1-917-907-4239
Danielle.lewis@pharma.com

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