Safety, Pharmacokinetics (PK), and Effectiveness of Hydrocodone Bitartrate (HYD) Extended-Release Tablets in Children
Safety, Pharmacokinetics (PK), and Effectiveness of Hydrocodone Bitartrate (HYD) Extended-Release Tablets in Children
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and effectiveness
 of Hydrocodone Bitartrate (HYD) tablets in children with moderate to severe pain requiring
 around-the-clock opioid analgesics.
Inclusion Criteria include:

 1. Males and females, aged 12 to 17 years, with pain severe enough to require daily,
 around-the-clock opioid treatment at a dose equivalent to at least 20 mg daily of
 hydrocodone for at least 2 weeks.

 2. Patients must have stable vital signs and hemoglobin oxygen saturation, eg, measured
 by pulse oximetry (SpO2).

 3. Patients must be willing and able to swallow medicinal tablets.

 4. Female patients of childbearing potential must have a negative pregnancy test within
 24 hours prior to the start of study drug treatment.

 5. Female patients who are sexually active must be using (and continue using throughout
 the study) an acceptable method of birth control, per investigator's discretion.

 6. 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.

 7. 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:

 1. Patients who require a starting total daily dose of HYD > 120 mg.

 2. Patients who have had surgery within 72 hours prior to the start of study drug
 treatment.

 3. Patients who have any planned surgery during the study will be excluded.

 4. Female patients who are pregnant or lactating.

 5. Patients who are allergic to hydrocodone or any other component of HYD or have a
 history of allergies to other opioids.

 6. Patients who receive or are expected to receive an investigational drug/therapy during
 the study drug treatment or follow-up period.

 7. Patients who are anticipated to receive any hydrocodone- or hydromorphone-containing
 products (other than study drug) during the study or 3 days prior to initiation of
 treatment with study drug.

 8. Patients with a history of alcohol, medication, or illicit drug abuse or addiction
 and/or opioid abuse or addiction at any time.

 9. Patients with contraindication to blood sampling.

 Other protocol-specific inclusion/exclusion criteria may apply.