Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children

An Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Efficacy of Buprenorphine Transdermal System (BTDS) in Children From 7 to 16 Years of Age, Inclusive, Who Require Continuous Opioid Analgesia for Moderate to Severe Pain

The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.

A study of safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years, inclusive, who require continuous opioid analgesia for moderate to severe pain.

Inclusion Criteria include:

• Male and female patients, 7 to 16 years of age, inclusive, with malignant and/or nonmalignant moderate to severe pain requiring or anticipated to require continuous, around-the-clock, opioid treatment for at least 2 weeks (based on the investigator's judgment);
• Patients must have written informed consent provided by the parent or legal guardian and assent provided by the patient, when appropriate;
• Patients on incoming opioids must be taking ≤ 80 mg/day morphine or equivalent if aged 12 to 16 years or ≤ 40 mg/day morphine or equivalent if aged 7 to 11 years prior to the screening visit;
• Patients and patient's parent/caregiver must be compliant with the protocol, ie, must be able to perform study assessments and understand and complete the age-appropriate scale to rate pain intensity. Patients must not have a cognitive developmental delay or any other condition that would preclude them from completing the age-appropriate pain scale.

Exclusion Criteria include:

• Patients who are allergic to buprenorphine or have a history of allergies to other opioids (this criterion does not include patients who have experienced common opioid side effects [eg, nausea, constipation]) or who have allergies or other contraindications to transdermal delivery systems or patch adhesives;
• Patients with a dermatological disorder, including burn and skin graft sites, at any relevant patch application site that would preclude proper placement and/or rotation of BTDS patches;
• Patients with evidence of impaired renal function;
• Patients with hepatic impairment;
• Patients with history of seizures;
• Patients with intracranial pressure;
• Patients who have a history of sleep apnea within the past year;
• Patients who require mechanical ventilation during study treatment period, are cyanotic, or who have unstable respiratory disease;
• Patients with clinically significant structural heart disease or a pacemaker;
• Patients with clinically unstable cardiac disease;
• Patients who receive or anticipate to receive investigational medication/therapy during study drug treatment period.

Other protocol-specific inclusion/exclusion criteria may apply.