New OxyContin Formulation Approved

The US Food and Drug Administration (FDA) approved a new formulation of controlled-release oxycodone (OxyContin). The goal of the new formulation is to help discourage misuse and abuse. Hopefully, this will ease doctor’s concerns about prescribing to legitimate pain patients and help make the painkiller more available to patients who need this medicine.

The new formulation is equivalent biologically to the old one, and because it is just a reformulation, FDA’s action doesn’t extend the exclusive marketing rights of the manufacturer (Purdue Pharma), so the timetable for a possible generic version hasn’t changed.

To cut the risk of overdose because of tampering and of abuse by snorting and injection, the new version is formulated so it can’t be crushed or chopped in a usual way and becomes gummy if it gets dissolved, so it can’t be drawn up into a syringe.

ICA participated in the stakeholder teleconference FDA held on Wednesday, April 7 to announce approval of the new formulation. During that teleconference, FDA’s Bob Rappaport, MD, explained that the agency will require the company to do a postmarketing study to collect data on how much the new formulation reduces abuse and misuse of this opioid. In addition, he said, FDA is requiring a “Risk Evaluation and Management Strategy” (REMS). This REMS will be a straightforward one that applies to this drug only: a medication guide will be issued to patients, and prescribers will be required to be educated about the appropriate use of opioid analgesics in the treatment of pain.

FDA didn’t take this opportunity to issue a REMS for all opioids. That’s still open for comment from legitimate pain patients like you who need these medications. Please continue to tell FDA how important your access to these medicines is and that you don’t need more barriers to receiving them.

• Send your comments with the title “Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting; Reopening of Comment Period.” Docket ID#: FDA-2009-N-0143.
• Submit your written comments to: Division of Dockets Management (HFA- 305); Food and Drug Administration; 5630 Fishers Lane, rm. 1061; Rockville, MD 20852.
• Submit electronic comments by going to regulations.gov. Click on the “Submit Comment” tab, enter the ID number (FDA-2009-N-0143), and then click “Submit a Comment” under “Actions.”
• Read the FDA press release about this announcement.
• For further information call 301-796-3448; or email: OpioidREMS@fda.hhs.gov.

Posted April 08, 2010