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Symproic Approved for Opioid-Induced Constipation

Purdue news release; 2017 Mar 23

FDA has approved Symproic (naldemedine), a once daily tablet from Shionogi and Purdue for the treatment of opioid-induced constipation for adults with chronic non-cancer-related pain. Symproic is expected to be commercially available by mid-summer.

Indications: Symproic, a schedule II controlled substance and opioid antagonist, is indicated for opioid-related constipation in adult patients who are suffering from chronic pain that has not been brought on by cancer. It is contraindicated in patients with a GI obstruction or suspected of having one because the drug increases the risk of GI perforation.

Dosage and administration: The recommended dose of Symproic is 0.2 mg once daily with or without food.

Adverse reactions: The most common adverse reactions include abdominal pain, diarrhea, gastroenteritis, and nausea. They occur in 8% or less of patients taking the medication.

Citation:

FDA Approves Symproic® (naldemedine) once-daily tablets C-II for the treatment of opioid-induced constipation in adults with chronic non-cancer Pain. [news release]. Stamford, Conn. http://www.purduepharma.com/news-media/2017/03/fda-approves-symproic-naldemedine-once-daily-tablets-c-ii-for-the-treatment-of-opioid-induced-constipation-in-adults-with-chronic-non-cancer-pain. Accessed April 5, 2017.