Interchangeability, Safety and Efficacy of Modified-Release Drug Formulations in the USA: The Case of Opioid and Other Nervous System Drugs

Clinical Drug Investigation
Enrique Seoane-VazquezRichard Hansen

Abstract

Modified-release drugs may provide clinical advantages compared to immediate-release forms and improve convenience to the patient and health outcomes. Concerns have been raised regarding interchangeability, efficacy, and safety of modified-release formulations. This study analyses all US Food and Drug Administration (FDA)-approved modified-release formulations and market trends, and illustrates how bioequivalence and safety of generic modified-release products compare to their respective brand name drugs and other generic drugs with different formulation design characteristics. This study also examines major concerns related to modified-release formulations: safety of opioids and bioequivalence of generic bupropion and methylphenidate. Study data were derived from the FDA electronic versions of the FDA's Orange Book (OB) and the FDA safety communications web page. Medicare Part D utilization and expenditures data were extracted from the Centers for Medicare and Medicaid. In May 2015, 276 (11.9 %) of the 2325 active ingredients and fixed-dose combinations listed in the FDA's Orange Book had at least one modified-release form approved by the FDA. The number of approvals increased over time; 52.5 % of modified releases were approv...Continue Reading

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Citations

May 7, 2016·International Journal of Pharmaceutics·Diana A van Riet-NalesFrancesca Cerreta
Feb 9, 2019·International Journal of Psychiatry in Clinical Practice·Pierre BlierMatthieu Boucher
Jun 27, 2020·Anesthesia and Analgesia·Rosa Rodriguez-MonguioEnrique Seoane-Vazquez
Dec 3, 2017·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Ning ChengRichard A Hansen
Sep 15, 2020·Anesthesia and Analgesia·Rosa Rodriguez-MonguioEnrique Seoane-Vazquez
Jun 12, 2021·The Clinical Journal of Pain·Nabarun DasguptaChris Delcher

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