Movantik (naloxegol)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved September 2014

Specific Treatments:

opiod-induced constipation in adults with chronic non-cancer pain

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General Information

Movantik (naloxegol)  is an antagonist of opioid binding at the mu-opioid receptor. When administered at the recommended dose levels, naloxegol functions as a peripherally-acting mu-opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids. 

Movantik is specifically indicated for the treatment of opiod-induced constipation in adults with chronic non-cancer pain.

Movantik is supplied as a tablet for oral administration. The recommended dosage is 25 mg once daily in the morning. If patients are not able to tolerate Movantik, reduce the dosage to 12.5 mg once daily. Take Movantik on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal. Swallow tablets whole, do not crush or chew. Avoid consumption of grapefruit or grapefruit juice during treatment with Movantik.

Clinical Results

FDA Approval

The FDA approval of Movantik was based on two randomized, double blind, placebo controlled trials. The trial enrolled subjects with opioid-induced constipation and chronic non-cancer pain receiving an opioid morphine equivalent daily dose of between 30 and 1,000 mg for at least four weeks before enrollment and self-reported OIC. A total of 652 patients in Study 1 and 700 patients in Study 2 were randomized to receive 12.5 mg or 25 mg of Movantik or placebo once daily for 12 weeks. The primary endpoint was response defined as: ≥3 SBMs per week and a change from baseline of ≥1 SBM per week for at least 9 out of the 12 study weeks and 3 out of the last 4 weeks. There was a statistically significant difference for the 25 mg Movantik treatment group versus placebo for the primary endpoint in Study 1 and Study 2. Statistical significance for the 12.5 mg treatment group versus placebo was observed in Study 1 but not in Study 2.

Side Effects

Adverse effects associated with the use of Movantik may include, but are not limited to, the following:

  • abdominal pain
  • diarrhea
  • nausea
  • flatulence
  • vomiting
  • headache

Mechanism of Action

Movantik (naloxegol)  is an antagonist of opioid binding at the mu-opioid receptor. When administered at the recommended dose levels, naloxegol functions as a peripherally-acting mu-opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids.

Additional Information

For additional information regarding Movantik or opioid-induced constipation in patients with chronic, non-cancer pain, please visit www.movantik.com