Stamford, CT, May 20, 2013 – Purdue Pharma L.P. will present several posters on Butrans® (buprenorphine) Transdermal System CIII at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 18th Annual International Meeting May 18 – 22 in New Orleans. Two of the posters focus on a study that utilized IMS database (private practitioner medical claims and pharmacy claims during 1/1/2011-11/30/2011) to analyze factors that influence persistence use of medication among people taking Butrans. The schedule for these posters being presented at ISPOR is as follows:
• Monday, May 20, 3:45 p.m. – 7:45 p.m., Poster No. PSY52
“Factors Predicting Medication Persistence Among Patients Initiating Buprenorphine Transdermal System.”
J. Pergolizzi, G. Hess, C. Chang, D Shah, K. Pierz, R. Ben-Joseph
• Monday, May 20, 3:45 p.m. – 7:45 p.m., Poster No. PSY53
“Impact of Dosage Strength on Medication Persistence Among Patients Treated with Buprenorphine Transdermal System.”
J. Pergolizzi, R. Ben-Joseph, C. Chang, K. Pierz, D Shah, G. Hess
Both studies were funded by Purdue Pharma L.P.
Butrans is indicated for the management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Limitations of Use
Butrans is not for use:
• As an as-needed (prn) analgesic
• For pain that is mild or not expected to persist for an extended period of time
• For acute pain
• For postoperative period unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time
A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks. Butrans is subject to the single, shared REMS for Extended-Release and Long-Acting (ER/LA) Opioid Analgesics. The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of ER/LA opioid analgesics while maintaining patient access to pain medications. Adverse outcomes of concern include addiction, unintentional overdose, and death.
The Full Prescribing Information for Butrans contains the following Boxed Warning:
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE
Abuse Potential
BUTRANS contains buprenorphine, an opioid agonist and Schedule III controlled substance with an abuse liability similar to other Schedule III opioids, legal or illicit [see Warnings and Precautions (5.1)]. Assess each patient’s risk for opioid abuse or addiction prior to prescribing BUTRANS. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving BUTRANS for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence (9)].
Life-Threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of BUTRANS, even when the drug has been used as recommended and not misused or abused [see Warnings and Precautions (5.2)]. Proper dosing and titration are essential and BUTRANS should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of BUTRANS or following a dose increase.
Accidental Exposure
Accidental exposure to BUTRANS, especially in children, can result in a fatal overdose of buprenorphine [see Warnings and Precautions (5.3)].
CONTRAINDICATIONS
Butrans is contraindicated in patients with:
? Significant respiratory depression
? Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
? Known or suspected paralytic ileus
? Hypersensitivity (e.g., anaphylaxis) to buprenorphine
WARNINGS AND PRECAUTIONS
• Abuse Potential
Buprenorphine can be abused in a manner similar to other opioid agonists, legal or illicit. Assess risk for opioid abuse or addiction prior to prescribing. Routinely monitor all patients for signs of misuse, abuse, and addiction. Addiction can occur even under appropriate medical use. Misuse or abuse of Butrans by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of the opioid and pose a significant risk that could result in overdose and death
• Life-Threatening Respiratory Depression
Respiratory depression is the primary risk of Butrans and may lead to respiratory arrest and death. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Butrans, the risk is greatest during the initiation of therapy or following a dose increase. Closely monitor patients for respiratory depression. Proper dosing and titration of Butrans are essential. Overestimating the Butrans dose when converting patients from another opioid product can result in fatal overdose with the first dose
• Accidental Exposure
Accidental exposure to Butrans, especially in children, can result in a fatal overdose
Elderly, Cachectic, and Debilitated Patients
Respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics. Monitor such patients closely, particularly when initiating and titrating Butrans and when Butrans is given concomitantly with other drugs that depress respiration
• Use in Patients with Chronic Pulmonary Disease
Monitor patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression for respiratory depression, particularly when initiating therapy and titrating with Butrans. Even usual therapeutic doses of Butrans may decrease respiratory drive to the point of apnea
• Interactions with Alcohol, CNS Depressants, and Illicit Drugs
Hypotension, profound sedation, coma or respiratory depression may result if Butrans is added to a regimen that includes other CNS depressants, alcohol, or illicit drugs
• QTc Prolongation
Avoid in patients with Long QT Syndrome, family history of Long QT Syndrome, or those taking Class IA or Class III antiarrhythmic medications
• Hypotensive Effects
Butrans may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. Monitor patients after initiating or titrating.
• Use in Patients with Head Injury or Increased Intracranial Pressure
Monitor patients who may be susceptible to the intracranial effects of CO2 retention for signs of sedation and respiratory depression, particularly when initiating therapy with Butrans. Opioids may also obscure the clinical course in a patient with a head injury
• Application Site Skin Reactions
In rare cases, severe application site skin reactions with signs of marked inflammation including “burn,” “discharge,” and “vesicles” have occurred
• Anaphylactic/Allergic Reactions
Cases of acute and chronic hypersensitivity to buprenorphine have been reported both in clinical trials and in the post-marketing experience
• Application of External Heat
Avoid exposing the Butrans application site and surrounding area to direct external heat sources. There is a potential for temperature-dependent increases in buprenorphine released from the system resulting in possible overdose and death Use in Patients with Gastrointestinal Conditions
Avoid the use of Butrans in patients with paralytic ileus and other GI obstructions. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms
• Avoidance of Withdrawal
When discontinuing Butrans, gradually taper the dose. Do not abruptly discontinue Butrans
ADVERSE REACTIONS
• Most common adverse reactions (=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 Please read accompanying Full Prescribing Information, including Boxed Warning.
The Full Prescribing Information for Butrans, including the Medication Guide and Boxed Warning is available at http://app.purduepharma.com/xmlpublishing/pi.aspx?id=b and at www.butrans.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
Contact:
Shirley Johnson
203-588-7681
Shirley.Johnson@pharma.com
