Bombed POI, hit on oral.
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Wyeth and Progenics Announce Preliminary Clinical Trial Results for RELISTOR Oral and Intravenous Formulations
Thursday May 22, 7:00 am ET
COLLEGEVILLE, Pa. & TARRYTOWN, N.Y.--(BUSINESS WIRE)--Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE - News), and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX - News), today announced preliminary results from two clinical trials conducted with investigational oral and intravenous formulations of RELISTOR™ (methylnaltrexone bromide).
The first of these studies, a phase 2 trial, evaluated the effects of an oral formulation of RELISTOR for the treatment of opioid-induced constipation (OIC), in patients with chronic, non-malignant pain. This study showed positive activity.
The second study, a phase 3 trial, examined the use of an intravenous formulation of RELISTOR for post-operative ileus (POI). In this study, the drug did not meet its primary or secondary end points.
RELISTOR Oral Formulation
The study of the RELISTOR oral formulation was a double-blind, randomized, placebo-controlled phase 2 trial. In this four-week trial of 122 patients with chronic, non-malignant pain (such as back pain, neuropathic pain or osteoarthritis) who were receiving opioids for pain management, the once daily oral formulation of RELISTOR showed statistically significant activity as assessed by the occurrence of spontaneous bowel movements and other efficacy measures. This oral formulation was also shown to be generally well tolerated.
“We are pleased by the preliminary findings of this oral formulation,” says Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive Officer and Chief Science Officer of Progenics Pharmaceuticals, Inc. “We await results within the coming months from a second, ongoing phase 2 study involving the oral formulation of RELISTOR that was announced last July to have positive activity in a phase 1 trial.” |
