US FDA Approves MOVANTIK™ (naloxegol) Tablets C-II

POSTED BY

Meredith Hemler

On September 16, the US Food and Drug Administration approved MOVANTIK™ (naloxegol) tablets C-II as the first once-daily oral peripherally acting mu-opioid receptor antagonist (PAMORA) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.

Opioids play an important role in chronic pain relief by binding to mu-receptors in the central nervous system, but they also bind to mu-receptors in the gastrointestinal tract. That is why patients taking opioids for chronic pain can develop OIC.


For patients who take opioids for chronic pain, constipation is one of the most common side effects, which can continue throughout their pain management therapy.  

MOVANTIK is expected to be available by prescription in pharmacies nationwide in the first half of 2015.

MOVANTIK strengthens AstraZeneca’s existing portfolio of medicines and aligns with our strategic focus on scientific leadership. AstraZeneca is dedicated to filling an unmet need for adult patients taking prescription opioids for chronic non-cancer pain who are experiencing OIC not adequately relieved by laxatives. It reflects our ongoing commitment to developing treatment options and supporting health care providers, patients and caregivers.

Important Safety Information for MOVANTIK

  • MOVANTIK is contraindicated in:
    • Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent obstruction due to the potential for GI perforation
    • Patients receiving strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms
    • Patients with a known serious or severe hypersensitivity reaction to MOVANTIK or any of its excipients
  • Cases of GI perforation have been reported with the 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 severe, persistent, or worsening abdominal pain; discontinue if this symptom develops
  • Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with MOVANTIK. Patients receiving methadone in the clinical trials were observed to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. Monitor for symptoms of opioid withdrawal when using MOVANTIK in such patients.
  • The most common adverse reactions with MOVANTIK in clinical trials were: abdominal pain (21%), diarrhea (9%), nausea (8%), flatulence (6%), vomiting (5%), headache (4%), and hyperhidrosis (3%)

Please see full US Prescribing Information

http://www.azpicentral.com/movantik/movantik.pdf

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088

3026008 Last Updated 9/14

tagged with fda, MOVANTIK, OIC