Progenics Pharmaceuticals Inc., engaged in the development and commercialization of therapeutic products to treat debilitating conditions and life-threatening diseases, today provided an update of the safety and efficacy endpoints achieved from its phase III study of RELISTOR (methylnaltrexone) for the treatment of opiod-induced constipation (OIC).
The one-year study involved 1,034-patients OIC. At a fixed dose of 12 mg, the drug was shown to be generally safe and well tolerated. Patients experienced consistent results across all monthly intervals; 34 percent of 12 mg injections resulted in bowel movements within four hours during the treatment period.
“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,” Robert Israel, M.D., senior vice president of medical affairs at Progenics stated in the press release. “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 III efficacy study in non-malignant pain patients with OIC.”
The company will present the results at the annual meeting of the American Pain Society in Austin, Texas, this weekend.
This data, along with the company’s previous efficacy data, complete what the company needs for a supplemental New Drug Application being prepared for submission to the U.S. Food and Drug Administration, which the company anticipates submitting by the end of June.
Progenics and its commercialization partner, Salix Pharmaceuticals (SLXP), plan to seek approval for subcutaneous methylnaltrexone in non-malignant pain patients suffering from OIC.
For more information visit www.relistor.com and www.progenics.com