Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain

Subjects, once stabilized to Embeda, need only complete a minimum of 2 of the 6 week study
duration to satisfy the PK endpoint. A safety follow-up visit is required at 1 week post-last
dose.

Inclusion Criteria:

- Children 7-17 with moderate to severe pain requiring around the clock treatment with
an opioid analgesic.

- Be an experienced opioid user, defined as any subject treated with opioid therapy,
equivalent or equal to >20 mg per day of morphine, for a period of 3 consecutive days
immediately prior to first day of dosing.

Exclusion Criteria:

- Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation and behavior in
past year.

- Hypersensitivity to morphine, naltrexone.

- A life expectancy (assessed by investigator) of less than 6 months or is no longer
capable of taking medication orally.

- Undergone surgery within 3 days prior to the first day of dosing.