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Purdue and Shionogi Release Promising PAMORA Study Results

March 8, 2018
Symproic may ease opioid-induced constipation in patients with nonmalignant chronic pain without analgesia interference.

A PPM Brief

A 52-week controlled study of naldemedine (Symproic), a once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA), developed by Purdue Pharma (Stamford, CT) and Shionogi  (Osaka, Japan / Florham Park, NJ) has demonstrated safety, tolerability, and improved quality of life among study subjects.

The medication was FDA indicated in March 2017 for the treatment of opioid-induced constipation (OIC) in adult patients with chronic noncancer pain, according to a Purdue press release.

Published study results about the randomized, double-blind, placebo-controlled, parallel-group, Phase 3 clinical trial (COMPOSE-3) evaluated the long-term safety and tolerability of oral naldemedine 0.2 mg (once daily) in patients (aged 18 to 80) experiencing chronic noncancer pain. Participating subjects were on a stable opioid therapy and self-reported OIC even if on a routine laxative regimen, stated the release. Patients had chronic noncancer pain for at least 3 months and were receiving a stable daily dose of opioids (> or = to 30 mg oral MME) for at least one month prior to screening.

Of the patients screened (2,414), approximately 1,245 were determined to be eligible and randomized 1:1 to receive once-daily oral naldemedine 0.2 mg (n=623) or placebo (n=623) for 52 weeks. Similar proportions of patients taking naldemedine and placebo experienced adverse events (naldemedine, 68.4% (n=425) compared to placebo 72.1% (n=446); adverse events leading to study discontinuation, the most common being diarrhea, was 6.3% naldemedine 6.3% compared to 5.8% placebo. Other GI-related side effects include abdominal pain and vomiting.

Secondary endpoints on efficacy assessed opioid withdrawal, pain intensity, the frequency of bowel movements, constipation-related symptoms, and quality of life. These results were consistent among the two groups, with no significant differences reported in opioid withdrawal or pain intensity. Researchers noted in the paper that sustained significant improvements in bowel movement frequency and overall constipation-related symptoms and quality of life were observed with naldemedine (P ≤ 0.0001) compared to placebo.

The study authors concluded in the paper that,  “Naldemedine was generally well tolerated for 52 weeks and did not interfere with opioid-mediated analgesia or precipitate opioid withdrawal.” The medication further seemed to significantly increase bowel movement frequency, improve OIC symptomatic burden, and increase the study participants’ quality of life compared to placebo.

Last updated on: March 5, 2019
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