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
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
Copies of the posters used in Progenics' presentations are available to view in the Events section of its website, www.progenics.com.
This 52-week, phase 3, multi-center, international, open-label study of subcutaneous methylnaltrexone enrolled patients with chronic, non-malignant pain who were receiving stable (≥1 month) doses of opioids. A two week screening period was followed by a 48-week, open-label dose administration period and a two week, post-treatment follow-up period. Study participants were instructed to self-administer methylnaltrexone daily at a dose of 12 mg. Use of routine laxatives was permitted for the duration of the study.
About Opioids, Constipation and RELISTOR (methylnaltrexone bromide)
Opioid analgesics frequently are prescribed to manage pain in patients with advanced illness. Constipation commonly occurs in such patients, as opioids, which relieve pain by specifically interacting with mu-opioid receptors within the brain and spinal cord of the central nervous system (CNS), also interact with such receptors outside the CNS, including in the gastrointestinal tract. The resulting constipation can be debilitating. RELISTOR is a peripherally acting mu-opioid receptor antagonist that decreases the constipating effects of opioid pain medications, without affecting their ability to relieve pain, by selectively displacing opioids from such receptors in the gastrointestinal tract and thereby decreasing their constipating effects. Because of its chemical structure, RELISTOR does not affect opioid-mediated analgesic effects on the CNS. RELISTOR is the first approved medication that specifically targets the underlying cause of OIC.
RELISTOR subcutaneous injection is approved in
Important Safety Information for 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 four months has not been studied in the advanced illness population.
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.Use of RELISTOR has not been studied in patients with peritoneal catheters.
Safety and efficacy of RELISTOR have not been established in pediatric patients.
Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie's syndrome). Perforations have involved varying regions of the GI tract (e.g., stomach, duodenum, and colon).
Use RELISTOR with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with RELISTOR and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms.
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%).
RELISTOR full Prescribing Information for the U.S. is available at www.relistor.com.
Related Development Programs
Subcutaneous methylnaltrexone in chronic, non-malignant pain patients with OIC
The 1,034-patient, one-year, open-label, international, phase 3 safety study (reported on in this press release) to evaluate the long-term safety and tolerability of methylnaltrexone bromide subcutaneous injection in chronic, non-malignant pain patients with opioid-induced constipation was completed in
Oral methylnaltrexone in chronic, non-malignant pain patients with OIC
Progenics and Salix expect to complete enrollment in a 700-patient, international, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of oral methylnaltrexone to treat opioid-induced constipation in non-malignant pain patients by the end of
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For more information, please visit www.progenics.com.
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