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Movantik: New FDA Approved Drug for Constipation

by Roni Shye on September 22, 2014 at 3:24 pm

Movantik (naloxegol) is a new drug for the treatment of opioid-induced constipation in adult with chronic non-cancer pain—basically, it’s used to prevent constipation when you’re prescribed an opioid for pain relief. It was approved by the FDA on September 16, 2014, and should be available in the first half of 2015.

Why does a medication like Movantik help?

Usually, once opioid pain medications are absorbed by the body for pain relief, they’ll also bind to receptors in the stomach and cause constipation. By just filling the “spots” the opioid medications would take in the stomach, Movantik can help keep you from getting constipated while still allowing your pain medication to be effective.

What kind of drug is Movantik and are there any others in the same class?
Movantik belongs to a relatively new class of medications known as peripherally-acting mu-opioid receptor antagonists (PAMORA). There is another drug already available in the same class, Relistor. However, Relistor is only approved to treat opioid-induced constipation in patients with advanced illness—where Movantik is only approved for use in patients with chronic non-cancer pain.

Relistor’s manufacturer is seeking approval for use in both cases, but for the moment, there’s only one recommended medication for each situation.

How is Movantik usually taken, and in what strengths will it be available?
Movantik tablets have been approved in two strengths: 12.5 mg and 25 mg. The recommended dose is 25 mg once daily in the morning.

What some side effects of Movantik?

The most common side effects include stomach pain, diarrhea, headache, and gas.

Some more important information about Movantik:

  • Movantik should be taken on an empty stomach in the morning, 1 hour before the first meal of the day or 2 hours after a meal.
  • Movantik should be swallowed whole—don’t crush or chew it.
  • Movantik interacts with grapefruit and grapefruit juice, so no grapefruit while taking this medication.
  • Discontinue Movantik if you stop taking your opioid pain med.

Will Movantik be a controlled substance?

Yes. Movantik will be classified as a schedule II controlled substance because it is related to other opioids. (Other schedule II medications include oxycodone, Adderalland Vicodin, beginning in October 2014).

According to the DEA, schedule II substances have a high potential for abuse, with use potentially leading to severe psychological or physical dependence, and are considered dangerous.

Update: As of January 2015, Movantik (naloxegol) has been descheduled by the DEA. It is no longer considered a controlled substance. For more information, see the ruling here.

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