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The Division of Pharmacotherapies and Medical Consequences of Drug Abuse plans and directs studies necessary to identify, evaluate, develop, and obtain FDA marketing approval for medications to treat substance use disorders (SUDs). The Division develops and administers a program of basic and clinical research to develop innovative pharmacological (both chemical and biological) approaches to treat SUDs.
Sales of extended-release naltrexone have been slower than expected, notes Ivan Montoya, MD, Deputy Director of the Division of Pharmacotherapies and Medical Consequences of Drug Abuse at the National Institute on Drug Abuse (NIDA), who was part of the FDA panel that recommended approval of the medication. “Alkermes, the company that makes Vivitrol, has responded to slow sales by increasing the price, which makes it less accessible,” he says.
gov/grants/guide/notice-files/NOT-OD-00-038. html). The DSMB is responsible for reviewing interim and final data, and recommending whether the study should be continued, modified, or terminated. The DSMB reviews the protocols, monitors recruitment, adverse events, data quality, outcome data, and overall study performance. For those clinical trials that required by this policy to have a Data and Safety Monitoring Board (DSMB), the investigators have the option of having their study monitored by the DSMB of the Division of Pharmacotherapies and Medical Consequences of Drug Abuse.