By: Douglas C. Throckmorton, M.D.
Since the 1990’s, extended-release and high-potency opioids have been on the U.S. market, providing a new option to help the treatment of pain. Unfortunately, while these pain relievers often have provided tremendous relief for many, their abuse has reached epidemic levels in the U.S., with devastating consequences to families and patients.
Over the years, FDA has worked diligently with many partners to address this crisis, while also working to ensure that patients in pain have appropriate access to opioid pain relievers.
One important step towards the goal of creating safer opioids, and one that is a high public health priority for FDA, is to encourage the development of formulations of these drugs that deter their abuse.
Today we’ve announced two actions that signal progress in the battle against the abuse of opioid drugs. First, we approved updated labeling for Purdue Pharma’s reformulated version of OxyContin extended-release (ER) tablets. The new labeling describes the product’s abuse-deterrent properties. These physical and chemical properties make it more difficult to crush, break, or dissolve the tablets. These properties are expected to make abuse by injection difficult and to reduce abuse by snorting. This is the first time we have approved such language in opioid drug labeling, and we made this determination after carefully reviewing the available science.
Our other action today was determining that the original formulation of OxyContin ER, which Purdue Pharma stopped shipping in August 2010, was removed from the market for reasons of safety or effectiveness. This finding is important because it means that FDA will not accept or approve any generic forms of the original OxyContin ER.
In making these decisions, FDA was focused on the relatively-new science of abuse deterrence in which the analytical, clinical, and statistical methods for evaluating these technologies are rapidly evolving. Our decision was grounded in the best available science. To guide drug development in this new field, FDA also issued a draft guidance for industry in January, announcing a flexible, adaptive approach to encourage the development of abuse-deterrent opioids. We believe such products have promise to help reduce prescription drug abuse and improve public health.
In the guidance, we describe four categories of abuse deterrence studies and lay out the kinds of labeling language we would consider approving, depending on the scientific data available. And because the science of abuse deterrence is evolving, we’re encouraging feedback and further development in this area, to help speed progress.
Moving forward, FDA will review every application on its own merits, based on applicable scientific and legal standards, and encourage an ongoing dialogue with manufacturers as they consider developing abuse deterrent opioid analgesic products. In addition to scientific rigor, flexibility is essential to encourage innovation, and, in essence, we’ll let manufacturers know where we want them to go, but not prescribe how exactly to get there. Our general goal, overall, is to encourage development of abuse-deterrent opioid products.
Today’s actions are significant components in a much larger effort to address prescription opioid abuse. We will continue to engage with the many groups active in this area – advocacy organizations, patients and family members, Congress, healthcare providers, and other federal government partners. Reducing the tragic toll of opioid abuse in the U.S. depends on this vital collaboration.
Douglas C. Throckmorton, M.D., is FDA’s Deputy Director for Regulatory Programs in the Center for Drug Evaluation and Research.