FDA EIR - Michael E. Thase, M.D. - September 18, 2018

An FDA inspection was conducted at the site of Clinical Investigator Michael E. Thase, M.D., in Philadelphia, PA, from September 17-18, 2018. This initial review was a high-priority assignment for a Pre-Market Original New Drug Application, guided by Compliance Program 7348.811 for Clinical Investigators. The inspection evaluated Dr. Thase's conduct of Protocol ALKS5461-202, a clinical study investigating ALKS 5461 for Major Depressive Disorder.

Two main observations were noted. Firstly, the informed consent documents lacked the required "clinicaltrials.gov" statement. Secondly, source documents presented conflicting information regarding a study subject's eligibility, specifically concerning the duration of prior antidepressant treatment, making it difficult to confirm adherence to inclusion criteria.

Despite these findings, no formal Form FDA-483 (Inspectional Observations) was issued, indicating these were not considered significant deficiencies. Dr. Thase provided a signed "Note to File" addressing the "clinicaltrials.gov" omission and outlining corrective actions for future studies. The eligibility discrepancy was discussed with the study team. Study records generally appeared accurate, and protocol procedures were followed.