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FDA approves Movantik for opioid-induced constipation

  1. RoboCodeine7610
    The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.

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    Opioids are a class of drugs that are used to treat and manage pain. A common side effect associated with the use of these drugs are that they reduce the gastrointestinal tract’s motility, making bowel movements difficult and causing patients to strain, have hard or lumpy stools or experience a sensation of incomplete evacuation. Movantik belongs to a class of drugs called peripherally acting opioid receptor antagonists, which are used to decrease the constipating effects of opioids.

    “Supportive care products such as Movantik can lessen the constipating side effects of opioids,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

    Movantik’s safety and effectiveness were established in two clinical trials of 1,352 participants who had taken opioids for at least four weeks for non-cancer related pain and had opioid-induced constipation. Participants were randomly assigned to receive 12.5 mg or 25 mg of Movantik or placebo (sugar pill) once daily for 12 weeks. The trials were designed to measure the change in the number of bowel movements per week from the start of the study.

    Results of the first trial showed that 44 percent of participants receiving 25 mg of Movantik and 41 percent of participants receiving 12.5 mg of Movantik experienced an increase in bowel movements per week, compared to 29 percent of participants receiving placebo. The second trial showed similar results.

    Common side effects of Movantik include abdominal pain, diarrhea, headache and the experience of excessive gas in the stomach or intestinal area (flatulence).

    The FDA is requiring a postmarketing study to further evaluate the potential risk of cardiovascular adverse events in patients taking Movantik. In June, the FDA held a public meeting to discuss what studies might be required to assess the cardiac safety of peripherally acting opioid receptor antagonists, including Movantik, intended to treat opioid-induced constipation.

    Movantik is distributed by AstraZeneca Pharmaceuticals LP, based in Wilmington, Delaware.

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

    FDA News Release
    September 16, 2014
    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm414620.htm

Comments

  1. 5-HT2A
    A peripheral opioid receptor antagonist. Fascinating! Thanks for posting this.
  2. babalooj
    I wonder how this drug compares to methylnaltrexone, which is another peripheral opioid antagonist marketed for the same reasons, but as a prescribed self-injection. I haven't heard anything good about methylnaltrexone, though i also haven't heard anything so bad, so i wonder how or why this drug would be any different/better, except that it is a pill instead of a pre-filled syringe, which is a plus for a lot of people with needle phobias or those trying to get past a needle fixation
  3. RoboCodeine7610
    I'm guessing even a peripheral opioid antagonist would be unpleasant to take for anyone with a physical dependence. After all, some of the symptoms of withdrawal are mediated through the peripheral nervous system.

    Sounds like an excellent option for patients needing long-term pain management though,

    Robo
  4. assassoid
    I'm on Suboxone and have some samples of Movantik, but all I can find are horror stories about it causing hour and hours of withdrawal when I google it . I don't need any withdrawal.

    I have been taking epsom salt every second day in order to move my bowels but ... as much as one mite not want these details... it doesn't really allow a bowel movement with me, it's just 2 or 3 hours of liquid diarrhea.. which beats an impaction.

    Anyone take Movantik with Rx opioids for pain/whatever and avoid any bad side effects?
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