Re-Treatment Study of Probuphine in Opioid Addiction

Inclusion Criteria:

- Subject has voluntarily provided written informed consent prior to conducting any
study-related procedures

- Completion of 24 weeks of treatment in PRO-806

- Subject has been deemed appropriate for entry into this extension study by the
investigator

- Females of childbearing potential must be willing to use a reliable means of
contraception during the entire study.

Exclusion Criteria:

- An aspartate aminotransferase (AST) levels ≥ 3 X the upper limit of normal, alanine
aminotransferase (ALT) levels ≥ 3 X the upper limit of normal, total bilirubin ≥ 1.5 X
the upper limit of normal, or creatinine ≥ 1.5 X upper limit of normal on the
screening laboratory assessments

- A current diagnosis of chronic pain requiring opioids for treatment

- A pregnant or lactating female

- Current use of agents metabolized through Cytochrome P450 3A4 (CYP 3A4) such as azole
antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), or
protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)

- A history of coagulopathy within the past 90 days, and/or current anti-coagulant
therapy such as warfarin

- A significant medical or psychiatric symptoms, cognitive impairment, or other factors
which in the opinion of the Investigator would preclude compliance with the protocol,
subject safety, adequate cooperation in the study, or obtaining informed consent

- Any current medical conditions such as severe respiratory insufficiency that may
prevent the subject from safely participating in study, or any pending legal action
that could prohibit participation or compliance in the study