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

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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 Neuroth
er. 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.

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