STAMFORD, Conn., Sept. 9 /PRNewswire/ -- Purdue Pharma L.P. will present data from the clinical program for Butrans™ (buprenorphine) Transdermal System CIII in a series of posters at PAINWeek® 2010, September 8-10 in Las Vegas.
Butrans recently received marketing approval from the U.S. Food and Drug Administration and is expected to be commercially available in the U. S. during the first quarter of 2011.
The featured studies evaluated the safety and efficacy of Butrans in a variety of patient scenarios. They include:
The professional product labeling for Butrans™ contains the following Boxed Warning:WARNING: IMPORTANCE OF PROPER PATIENT SELECTION, POTENTIAL FOR ABUSE, AND LIMITATIONS OF USEProper Patient SelectionButrans is a transdermal formulation of buprenorphine indicated for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. Potential for Abuse Butrans contains buprenorphine which is a mu opioid partial agonist and a Schedule III controlled substance. Butrans can be abused in a manner similar to other opioid agonists, legal or illicit. Consider the abuse potential when prescribing or dispensing Butrans in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Assess patients for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Routinely monitor all patients receiving opioids for signs of misuse, abuse and addiction. Limitations of UseDo not exceed a dose of one 20 mcg/hour Butrans system due to the risk of QTc interval prolongation. Avoid exposing the Butrans application site and surrounding area to direct external heat sources. Temperature-dependent increases in buprenorphine release from the system may result in overdose and death. Butrans is indicated for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time.
Butrans is contraindicated in patients who have significant respiratory depression, severe bronchial asthma, who have or are suspected of having paralytic ileus or known hypersensitivity to any of its components or the active ingredient, buprenorphine, as well as those who require opioid analgesia for a short period of time, who require the management of post-operative pain, including use after out-patient or day surgeries, the management of mild pain, and the management of intermittent pain (e.g., use on an as needed basis).
Three strengths of Butrans will be available: 5, 10, and 20 mcg/hour; each single transdermal system is intended to be worn for seven days. Do not exceed a dose of one 20 mcg/hour Butrans system due to the risk of QTc interval prolongation. Avoid exposing the Butrans application site and surrounding area to direct external heat sources. Temperature-dependent increases in buprenorphine released from the system may result in overdose and death.
Warnings and Precautions
Clinical Trial Experience The efficacy of Butrans has been evaluated in four 12-week double-blind, controlled clinical trials in opioid-naive and opioid-experienced patients with moderate to severe chronic low back pain or osteoarthritis using pain scores as the primary efficacy variable. Two studies in low back pain (described below) demonstrated efficacy while one study in low back pain failed to show efficacy and one study in osteoarthritis, that included an active comparator, failed to show efficacy for Butrans and the active comparator.
Evidence of efficacy has been provided through the study of more than 1,200 patients in two pivotal analgesic trials. One trial enrolled patients who were opioid-naive while the other enrolled patients who were opioid-experienced. Each of these two adequate and well controlled trials enrolled patients suffering from moderate to severe chronic low back pain, included a 12-week double-blind phase and utilized pain scores as the primary efficacy variable. Butrans improved pain scores in opioid-naive and opioid-experienced patients with moderate to severe chronic pain requiring continuous, around-the-clock treatment for an extended period of time.
Both of the pivotal clinical studies enrolled adult patients with moderate to severe chronic low back pain and included open-label titration periods followed by randomized, double-blind, 12-week study periods.
One study was a placebo-controlled study that enrolled opioid naive patients who were suboptimally responsive to their non-opioid therapy (e.g., NSAIDs, acetaminophen). In this study, 53 percent of the patients who entered the open-label titration period were able to titrate to a tolerable and effective dose and were randomized into a 12-week, double-blind treatment period. Twenty three percent of patients discontinued due to an adverse event and 14 percent discontinued due to lack of a therapeutic effect from the open-label titration period. During the double-blind treatment, in the Butrans 10 or 20 mcg/hour group, 9 percent discontinued early due to lack of efficacy and 16 percent due to adverse events; in the placebo group, 13 percent discontinued early due to lack of efficacy and 7 percent due to adverse events.
The second study used a low dose Butrans control group (Butrans 5 mcg/hour) and enrolled patients who had been previously treated with a variety of opioids in conjunction with or without non-opioid therapies. In this study, 57 percent of the patients who entered the open-label titration period were able to titrate to and tolerate the adverse effects of Butrans 20 mcg/hour and were randomized into a 12-week double-blind treatment phase. Twelve percent of patients discontinued due to an adverse event, and 21 percent discontinued due to lack of a therapeutic effect during the open-label titration period. During the double-blind treatment in the Butrans 20 mcg/hour group, 11 percent discontinued early due to lack of efficacy and 13 percent due to adverse events; in the Butrans 5 mcg/hour group, 24 percent discontinued early due to lack of efficacy and 6 percent due to adverse events.
Adverse Event InformationThe most common adverse events (greater than or equal to 5%) reported by patients treated with Butrans in the clinical trials were nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash. The most frequently occurring application site skin reactions were application site pruritus, erythema, rash and irritation. In rare cases, severe application site skin reactions with signs of marked inflammation including "burn," "discharge," and "vesicles" have occurred.
The Full Prescribing Information for Butrans is available at www.purduepharma.com/PI/prescription/ButransPI.pdf. Additional information, including a Medication Guide, is available at www.Butrans.com. Working with the FDA, Purdue has also developed a Risk Evaluation and Mitigation Strategy (REMS) for Butrans. The Butrans REMS will include a Medication Guide, Elements to Assure Safe Use, such as healthcare providers training, and a timetable for submitting assessments of the REMS. This information will be available at www.butransrems.com.
About Purdue Pharma L.P.Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.
|SOURCE Purdue Pharma L.P.|
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