Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
The Food and Drug Administration April 16 said it approved updated labeling for Purdue Pharma LP's reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets.
The agency also said it will not approve any generics that rely on the older version of the pain drug.
According to the agency, the new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via snorting.
“Additionally, because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness,” FDA said.
Because of this, FDA “will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin.”
The agency noted that in reaching its decision, it reviewed citizen petitions requesting that FDA determine whether original OxyContin was voluntarily withdrawn from sale for reasons other than safety or effectiveness. In a Federal Register notice set for April 18 publication, the agency said the tablets approved under new drug application 20-553 “were withdrawn from sale for reasons of safety or effectiveness.”
FDA said it approved the original formulation of OxyContin in late 1995.
“The product was abused, often following manipulation intended to defeat its extended-release properties,” FDA said, adding that such manipulation “causes the drug to be released more rapidly, which increases the risk of serious adverse events, including overdose and death.”
In April 2010, FDA approved a reformulated version of OxyContin, which was designed to be more difficult to manipulate for misuse or abuse (8 PLIR 467, 4/9/10). Purdue stopped shipping original OxyContin to pharmacies in August 2010, the agency noted.
Douglas Throckmorton, deputy director for regulatory programs in FDA's Center for Drug Evaluation and Research, said in an agency statement that while “both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin.” FDA noted that abuse of OxyContin by these routes, as well as the oral route, still is possible.
FDA said it determined that the reformulated product has abuse-deterrent properties. The tablet is more difficult to crush, break, or dissolve, the agency said, adding that it forms a “viscous hydrogel and cannot be easily prepared for injection.”
The reformulated product also may reduce incidents of therapeutic misuse, such as crushing the product to sprinkle it onto food or to administer it through a gastric tube, the agency said.
“When FDA finds that a new formulation has abuse deterrent properties, the agency has the authority to require generics to have abuse-deterrent properties also,” the agency statement said.
FDA is taking other measures to address concerns about the abuse of pain drugs. In late March, an agency official said FDA will hold a public meeting at the end of September to seek input on its draft guidance for the development of abuse-deterrent opioids (11 PLIR 436, 4/5/13). In January, FDA issued a draft guidance to help industry develop new formulations of opioid drugs with the goal of preventing abuse (11 PLIR 46, 1/11/13).
A prepublication copy of the Federal Register notice about OxyContin is at http://op.bna.com/hl.nsf/r?Open=bbrk-96ts9g.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)