Regulatory Aspects of New Medications to Treat Addictions: The U.S. IND Process

Abstract

In most countries, for a medication to be available to treat addictions, it must first go through a development and approval process. In the United States, the Center of Drug Evaluation and Research (CDER), of the Food and Drug Administration (FDA), is the Federal agency responsible for approving new addiction pharmacotherapies based upon their safety and efficacy. The Investigational New Drug (IND) application is the means by which FDA allows a new medication to be studied in humans. In order to be able to test a potential medication for addiction in humans, FDA requires certain tests to be conducted to (1) characterize the chemical properties of the molecule so that it can be manufactured and formulated reliably over several batches, (2) determine the toxicological properties of the medication so that it can be administered at safe doses, (3) ensure that anticipated toxicities can be monitored for in a study to avoid irreparable harm to study subjects, and (4) identify potential interactions that may occur when the medication is used in combination with the drug of abuse. This chapter will provide an overview of the IND process, the sections of an application, maintenance of an IND, and important meetings and identify the conditions for which a study is exempt from requiring an IND.