FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Symproic (naldemedine)

Indication:

Opioid-induced constipation (OIC).

Mechanism:

Peripherally acting mu-opioid receptor antagonist (PAMORA). Derivative of naltrexone to which a side chain has been added that increases the molecular weight and the polar surface area, thereby reducing its ability to cross the blood-brain barrier.

Dosage:

0.2 mg PO once daily.

Approval:

Approval was based on the COMPOSE clinical trials. COMPOSE III was a 52-week, randomized, double-blind, placebo-controlled, long-term safety study that included approximately 620 adults with OIC and chronic noncancer pain. The treatment group showed significant improvements in weekly bowel movement frequency compared with placebo at all time points measured (P≤0.0001) and no significant opioid withdrawal signs or symptoms.

Reference:

Webster L, et al. (abstract) Long-term safety and efficacy of naldemedine for the treatment of opioid-induced constipation in subjects with chronic non-cancer pain receiving opioid therapy: Results from a 52-week Phase 3 clinical trial. Presented September 7, 2016 at PAINWeek in Las Vegas.

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