ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults

A Multi-Center Extension of Alkermes' Study ALK21-003-EXT (NCT01218971) to Evaluate the Long-Term Safety of Medisorb® Naltrexone

This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).

Enrolled subjects continued to receive the same dose strength of Medisorb naltrexone (ie, 190 mg or 380 mg) they had received in Study ALK21-003-EXT (NCT01218971). Assigned dose strength (high or low) was not revealed to the subject, the study investigators, or any blinded member of the clinical study team for the duration of the study period. Placebo was not administered.

Primary Inclusion Criteria:

• Completed Study ALK21-003-EXT (NCT01218971), receiving all 13 injections
• Willing and able to return for scheduled clinic visits and study assessments
• Noncustodial, stable address and phone
• Written, informed consent

Primary Exclusion Criteria:

• Pregnancy or lactation
• Terminated early from study drug in Study ALK21-003-EXT (NCT01218971)