The Hospice Clinician Blog

Salix Pharmaceuticals and Progenics Pharmaceuticals announced the successful outcome of a recently completed Phase 3 trial evaluating the efficacy and safety of oral methylnaltrexone for the treatment of opioid-induced constipation.

Constipation commonly occurs in hospice and palliative care patients taking opioids for chronic pain. Methylnaltrexone is indicated for relief of opioid-induced constipation in these patients, when laxative therapy has been insufficient. Methylnaltrexone is a peripherally acting mu-opioid antagonist. It antagonizes the effects of opioids on peripheral tissues, including the gastrointestinal tract, without affecting the opioid’s analgesic effect. Methylnaltrexone is highly effective and well-tolerated, but is currently available only in injectable form for subcutaneous injection (brand name Relistor®).

The Phase 3 trial of oral methylnaltrexone evaluated three once-daily oral dosing regimens (150, 300 and 450 mg) and demonstrated highly statistically significant results in both the 300 and 450 mg treatment arms. Overall, efficacy of oral methylnaltrexone in this study was comparable to that reported in clinical studies of subcutaneous methylnaltrexone in subjects with chronic pain. The overall observed safety profile seen in patients treated with oral methylnaltrexone was comparable to placebo.

Salix and Progenics plan to submit a New Drug Application to the FDA in mid-2012.

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