Purdue Pharma L.P. Receives FDA Approval For 15 mcg/hour Dosage Strength Of Butrans (buprenorphine) Transdermal System CIII

STAMFORD, Conn., Sept. 24, 2013 /PRNewswire/ -- Purdue Pharma L.P. announced that the U.S. Food and Drug Administration (FDA) approved a new 15 mcg/hour dosage strength of Butrans® (buprenorphine) Transdermal System CIII, which will provide an additional titration option for healthcare professionals. Four strengths of Butrans will now be available: 5, 10, 15 and 20 mcg/hour. Purdue expects to launch Butrans 15 mcg/hour commercially in the U.S. in October 2013.

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 pain 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.

Butrans is the first transdermal system that delivers a continuous release of buprenorphine for seven days. The active ingredient in Butrans Transdermal System is buprenorphine, a partial agonist at mu opioid receptor, and a Schedule III controlled substance.

"The approval of Butrans 15 mcg/hour dosage offers healthcare professionals added flexibility when using Butrans for the management of moderate to severe chronic pain," said Gary Stiles, M.D., Senior Vice President, Research and Development, Purdue Pharma L.P. "The new strength provides another option when adjusting the dose to obtain an appropriate balance between adequate pain relief and opioid-related adverse reactions."

"The approval of the 15 mcg/hour patch of Butrans provides healthcare professionals the ability to individualize the dose of Butrans to the specific needs of patients," said Jeffrey A. Gudin, M.D., Director of The Pain Management and Wellness Center at Englewood Hospital and Medical Center.

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)].

Parentheses refer to sections in the Full Prescribing Information.

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.
The Full Prescribing Information for Butrans, including the Medication Guide and Boxed Warning is available at www.purduepharma.com/butranspi and at www.butrans.com .   

Butrans can be abused in a manner similar to other opioid agonists, legal or illicit. Purdue supports prescriber and patient education as part of a comprehensive approach to address misuse, abuse and diversion of opioid pain medicines, while ensuring that these medications remain accessible for patients with moderate to severe, chronic pain when appropriate. Information on the shared REMS is available at www.ER-LA-opioidREMS.com.

Purdue Pharma L.P.
Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on chronic 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.

 
CONTACT: Shirley Johnson, 203-588-7681, Shirley.Johnson@pharma.com

Web Site: http://www.purduepharma.com
 

Posted: September 2013

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Butrans (buprenorphine) FDA Approval History

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