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Drug proves effective in opioid-induced constipation
At a fixed dose of 12 mg, methylnaltrexone bromide (Relistor, Progenics Pharmaceuticals) subcutaneous injection proved generally safe and well tolerated in non-malignant pain patients with opioid-induced constipation, according to a recent study.
At a fixed dose of 12 mg, methylnaltrexone bromide (Relistor, Progenics Pharmaceuticals) subcutaneous injection proved generally safe and well tolerated in non-malignant pain patients with opioid-induced constipation (OIC), according to a 1,034-patient, 1-year phase 3 study. The safety profile was similar to that from a previously reported, shorter-duration efficacy study.
Patients experienced consistent results across all monthly intervals, and 34.1% of methylnaltrexone 12-mg subcutaneous injections resulted in bowel movements within 4 hours during the treatment period. Subjective assessments by patients showed statistically significant reductions from baseline in straining and the number of bowel movements accompanied by the sensation of complete evacuation.
“The 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, MD, senior vice president of medical affairs at Progenics Pharmaceuticals.. “We found that the 4-hour response rate remained durable over the course of the 1-year study period.”
Patients in the study included those with a history of chronic, non-malignant pain (including back pain, joint/extremity pain, neurologic/neuropathic pain, and fibromyalgia), and who experienced constipation during opioid pain medication use for at least 1 month prior to screening. Of the patients in the study, 624 were treated for 6 months or more, and 477 completed the 48-week study and post-treatment follow-up periods. Patients received a median of 6 subcutaneous injections per week of methylnaltrexone 12 mg for up to 48 weeks.
There were no unexpected adverse effects and pain scores confirmed that the drug did not interfere with analgesia or cause opioid withdrawal symptoms.
A supplemental New Drug Application is being prepared for submission to FDA by the end of June. Results of the study were presented at the recent annual meeting of the American Pain Society in Austin, Texas.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
