Progenics Pharmaceuticals, Inc. today provided analyses of safety and efficacy endpoints from the 1,034-patient, one-year phase 3 safety study of methylnaltrexone bromide subcutaneous injection in non-malignant pain patients with opioid-induced constipation (OIC). At a fixed dose of 12 mg, the drug was shown to be generally safe and well tolerated, with a safety profile similar to that from a previously reported, shorter-duration efficacy study in non-malignant pain patients. The results are being presented at the annual meeting of the American Pain Society in Austin, TX, May 19-21, 2011.
Patients experienced consistent results across all monthly intervals, and 34.1% of methylnaltrexone 12 mg subcutaneous injections resulted in bowel movements within four hours during the treatment period. In addition, patient subjective assessments showed statistically significant improvements from baseline for a reduction in straining and for the number of bowel movements accompanied by the sensation of complete evacuation.
"This study yielded safety and efficacy data that support the potential utility of subcutaneous methylnaltrexone for use by patients who take opioids for pain over extended periods," said Robert Israel, M.D., senior vice president of medical affairs at Progenics. "We found that the four-hour response rate remained durable over the course of the one-year study period. In addition, the assessed safety of long-term methylnaltrexone use was consistent with previously reported results of the three-month phase 3 efficacy study in non-malignant pain patients with OIC."
The safety study included patients who had a history of chronic, non-malignant pain (including back pain, joint/extremity pain, neurologic/neuropathic pain and fibromyalgia) and who experienced constipation resulting from opioid pain medication use for at least one month prior to screening. Of the 1,034 patients who received at least one dose of methylnaltrexone, 624 patients were treated for six months or more, and 477 completed the 48-week study and post-treatment follow-up periods. Patients took a median of six subcutaneous injections per week of methylnaltrexone 12 mg for up to 48 weeks. There were no observed unexpected safety signals, or cases of gastrointestinal perforation in the study. Pain scores and opioid use data confirmed that methylnaltrexone 12 mg subcutaneous injection did not interfere with analgesia or cause opioid withdrawal symptoms.
These safety data, together with previously announced efficacy data, complete the major data packages for a supplemental New Drug Application being prepared for submission to the U.S. Food and Drug Administration by the end of June. In this application, Progenics and its commercialization partner, Salix Pharmaceuticals (Nasdaq:SLXP), plan to seek approval for subcutaneous methylnaltrexone in non-malignant pain patients suffering from opioid-induced constipation. Methylnaltrexone currently is approved and marketed as RELISTOR® for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.
No comments:
Post a Comment