Shionogi and Purdue announced the launch of Symproic (naldemedine) tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (eg, weekly) opioid dosage escalation.
Symproic, initially approved as a CII controlled substance in March 2017, was officially descheduled by the Drug Enforcement Agency (DEA) in September 2017. It is an oral peripherally-acting mu-opioid receptor antagonist (PAMORA) that acts in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids. Its ability to cross the blood-brain barrier is reduced due to a side chain that has been added, which increases the molecular weight and polar surface area.
In clinical trials (COMPOSE 1, COMPOSE 2), the proportion of responders (patient who had at least 3 spontaneous bowl movements [SBM] per week and a change from baseline of at least 1 SBM/week for at least 9 out of the 12 weeks including 3 out of the last 4 weeks) was found to be significantly higher with Symproic vs placebo: COMPOSE 1 (48% vs 35%); COMPOSE 2 (53% vs 34%).
Symproic is available as 0.2 mg strength tablets in 90-count bottles.
FDA approves Symproic (naldemedine) once-daily tablets C-II for the treatment of opioid-induced constipation in adults with chronic non-cancer pain [press release]. Osaka, Japan; Florham Park, NJ; Stamford, Conn; Purdue: March 23, 2017. Accessed November 3, 2017.
This article originally appeared on MPR