The FDA has approved a new forumlation for controlled-released Oxycontin, a powerful pain medication that is typically prescribed severe, chronic pain. The goal of this new Oxycontin formula is to help discourage abuse and overuse of the drug. This could be really good news for chronic pain sufferers who have doctors who are afraid to prescribe the drug because of the previous threat of misuse. This new formula should put doctors at ease when prescribing Oxycontin and more patients who are legitimately suffering from pain should be able to get the drug.
The new Oxycontin formulation will be created in a way that the medication cannot be crushed for snorting or liquified for shooting up. If the new formula gets wet or someone tries to dissolve it, the drug will become gummy. Because there is just a reformulation of the drug, the timetable for a potential generic version hasn’t changed. More good news.
The Interstitial Cystitis Association was involved in the stakeholder teleconference FDA held on Wednesday, April 7 to announce approval of the new formulation. The ICA reports:
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.