Progenics Announces Clinical Completion Of Subcutaneous Methylnaltrexone Safety Study In Chronic Non-Malignant Pain Patients

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Pain / Anesthetics;  Palliative Care / Hospice Care
Article Date: 23 Sep 2010 - 3:00 PDT


Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) announced the completion of the treatment phase of a 1,034-patient, one-year, open-label, international, phase 3 safety study of methylnaltrexone bromide subcutaneous injection in chronic, non-malignant pain patients with opioid-induced constipation (OIC). Patients in the study were receiving opioid pain medications for conditions such as osteoarthritis, back pain and neuropathic pain. Progenics plans to include results from this study in a supplemental New Drug Application to be submitted to the U.S. Food and Drug Administration (FDA) in the first half of 2011.

"We expect to present an analysis of the full dataset of this safety study at a medical conference following the submission of a complete study report to FDA," said Paul J. Maddon, M.D., Ph.D., Progenics' Chief Executive Officer, Chief Science Officer, and Founder.

One-year Safety Study of Methylnaltrexone in Chronic, Non-Malignant Pain Patients: Trial Design

The study treated 1,034 patients with chronic, non-malignant pain who were initially screened over a two-week period for constipation resulting from treatment with various opioid regimens. Dosing was a minimum of one dose per week up to a maximum of one dose daily using pre-filled syringes. A 48-week treatment period was followed by a two-week follow-up period. The primary objective of the study was to evaluate the long-term safety and tolerability of methylnaltrexone in chronic, non-malignant pain patients with OIC.

The study was conducted by Progenics' RELISTOR (methylnaltrexone bromide) collaborator, Wyeth, a subsidiary of Pfizer Inc. Patient enrollment commenced in December 2008 and concluded in October 2009. Results from this study, together with a 460-patient, double-blind, randomized, international phase 3 efficacy study in chronic, non-malignant pain patients with opioid-induced constipation, are expected to be included in the sNDA submission in the first half of 2011.

About Subcutaneous RELISTOR

RELISTOR is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond 4 months has not been studied.

Important Safety Information for RELISTOR

- RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction

- If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician

- Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients. Use of RELISTOR with caution in patients with known or suspected lesions of the GI tract

- Use of RELISTOR has not been studied in patients with peritoneal catheters

- The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5% vs. 9.8%), flatulence (13.3% vs. 5.7%), nausea (11.5% vs. 4.9%), dizziness (7.3% vs. 2.4%), diarrhea (5.5% vs. 2.4%), and hyperhidrosis (6.7% vs. 6.5%)

- Safety and efficacy of RELISTOR have not been established in pediatric patients

Source:
Progenics Pharmaceuticals, Inc.

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