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Tolerability comparable to placebo in clinical trials

In clinical trials, SYMPROIC® (naldemedine) demonstrated low rates of adverse reactions. During a 12-week clinical trial, only 8% of patients taking SYMPROIC experienced abdominal pain.

Tolerability comparable to placebo in clinical trials

In clinical trials, SYMPROIC® (naldemedine) demonstrated low rates of adverse reactions. During a 12-week clinical trial, only 8% of patients taking SYMPROIC experienced abdominal pain.

Low rate of adverse reactions, including abdominal pain

12-week data from Studies 1 and 22,612-week data from 2 Studies showing improvements in abdominal pain, diarrhea, nausea and gastroenteritis
*Adverse reactions occurring in ≥2% of patients receiving SYMPROIC and at an incidence greater than placebo.Abdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, gastrointestinal pain.

Opioid withdrawal comparable to placebo2,6

  • 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

Explore the SYMPROIC dosing and administration guidelines

What are the side effects of SYMPROIC?

In SYMPROIC (naldemedine) clinical trials, patients experienced low rates of adverse reactions, including abdominal pain.1,2,6


Common side effects of SYMPROIC

  • Stomach pain/Abdominal pain
  • Diarrhea
  • Nausea
  • Vomiting (gastroenteritis)

What are the side effects of SYMPROIC?

In SYMPROIC (naldemedine) clinical trials, patients experienced low rates of adverse reactions, which including abdominal pain.1,2,6


Common side effects of SYMPROIC

  • Stomach pain/Abdominal pain
  • Diarrhea
  • Nausea
  • Vomiting (gastroenteritis)

Proven long-term tolerability over 52 weeks

Data from Study 31,2Data from study after 52 weeks showing sustained improvement
*Adverse reactions occurring in ≥2% of patients receiving SYMPROIC and at an incidence greater than placebo.Abdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, gastrointestinal pain.

Low rates of opioid withdrawal1,2

  • In a long-term study (52-week data), the incidence of adverse reactions of opioid withdrawal was 3% (20/621) for SYMPROIC and 1% (9/619) for placebo

SYMPROIC addresses the underlying cause of OIC

INDICATION

SYMPROIC® (naldemedine) 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.

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 naldemedine. Reactions have included bronchospasm and rash.
INDICATION

SYMPROIC® (naldemedine) 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.

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 naldemedine. 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 the potential for additive effect and increased risk of opioid withdrawal.

USE IN SPECIFIC POPULATIONS

Naldemedine 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 compared to placebo in two pooled 12-week studies were: abdominal pain (8% vs 2%), diarrhea (7% vs 2%), nausea (4% vs 2%), and gastroenteritis (2% vs 1%).

The incidence of adverse reactions of opioid withdrawal in two pooled 12-week studies was 1% (8/542) for SYMPROIC and 1% (3/546) for placebo. In a 52-week study, the incidence was 3% (20/621) for SYMPROIC and 1% (9/619) for placebo.

Please see Full Prescribing Information and Medication Guide for SYMPROIC.

To report SUSPECTED ADVERSE REACTIONS, contact BioDelivery Sciences International, Inc. at 1-800-469-0261 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

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