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

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 morphine or equivalent if aged 12
to 16 years or ≤ 40 mg morphine or equivalent if aged 7 to 11 years prior to
initiation with BTDS treatment;

- Patients must be able to understand and complete the age appropriate scale to rate
pain intensity, ie, patients must not have a cognitive developmental delay or any
other condition that would preclude them from completing age appropriate pain scale;

- Patients with malignant and/or nonmalignant medical conditions causing moderate to
severe pain requiring continuous, around-the-clock opioid analgesic therapy such as
cancer, sickle-cell disease (eg, resulting in persistent body pain, persistent limb
pain, avascular necrosis, persistent abdominal pain), persistent orthopedic pain (eg,
spinal injury, spinal disc herniation, persistent limb/stump pain, major trauma),
juvenile rheumatoid arthritis (pain not controlled by therapy treating the underlying
disease), and cystic fibrosis resulting in persistent chest pain;

- Patients must have a parent/caregiver who is willing and able to be compliant with
the protocol, capable of patient evaluation, able to read and understand
questionnaires, willing and able to use a diary, and able to read, understand, and
sign the written informed consent.

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]);

- Patients who have allergies or other contraindications to transdermal delivery
systems or patch adhesives;

- Patients with a dermatological disorder 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 who have a history of sleep apnea within the past year;

- Patients with unstable respiratory disease;

- Patients with structural heart disease or a pacemaker;

- Patients with clinically unstable cardiac disease;

- Patients who, in the opinion of the investigator, are unsuitable to participate in
this study for any reason;

- Patients who receive or anticipate to receive investigational medication/therapy
during study drug treatment period.

Other protocol-specific inclusion/exclusion criteria may apply.