New Oxycontin Formulation Saves Lives but May Be Less-Effective

Posted by: Matthew Biegun on May 24, 2011 at 12:17AM
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New Oxycontin® Formulation Prevents Abuse but Lacks Potency

OxyContin® (Purdue Pharmaceuticals) was approved by the Food and Drug
Administration (FDA) in 1995 as a sustained-release preparation of oxycodone hydrochloride and was thought to have much lower abuse potential than immediate-release oxycodone because of its slow-release properties.¹ However, beginning in 2000, widespread reports of OxyContin® abuse surfaced. Over the past 16 years, there have been reports, frequently anecdotal, that opioid analgesic abuse has evolved into a national epidemic.

OxyContin® abusers quickly realized that they could eliminate the slow-release mechanism by chewing or crushing the tablets, thus releasing the potent pain medication all at once. Abusers can further intensify the pain-killing effects by snorting or injecting the OxyContin® powder. Tampering with OxyContin® in this manner creates a dangerously powerful analgesic stronger than morphine or heroin.

FDA urges Purdue Pharmaceuticals to create "abuse-proof" Oxycontin®

An FDA advisory committee assigned with the task of curbing the prescription painkiller epidemic strongly urged Purdue Pharmaceuticals to create a new formulation that prevents abusers from chewing, snorting, or injecting OxyContin®. In 2010, Purdue Pharmaceuticals released Remoxy®, a gelatin capsule, which renders the medication resinous and difficult to crush for snorting or injection.

Remoxy® is a unique, long-acting formulation of oral oxycodone for moderate to severe chronic pain, designed to resist common methods of prescription drug misuse and abuse. Remoxy® is comprised of a high-viscosity, liquid formulation in a hard gelatin capsule that is designed to provide steady, around-the-clock pain relief, while resisting common methods of tampering intended to result in the rapid release of oxycodone.²

According to a recent study in the Journal of Pain Medicine, the abuse potential of Remoxy, when taken whole or chewed was significantly lower than original OxyContin® formulations with known abuse potential, including oxycodone IR and crushed oxycodone ER. Therefore, Remoxy® may be associated with a reduced risk potential for abuse.³

The new formulation provides an incremental and significant improvement in creating impediments to OxyContin’s controlled-release delivery system. The new formulation of OxyContin® is intended to be every bit as effective for patients as the original.

Patients Claim New Formulation Less-Effective

While OxyContin® abuse and overdose deaths have significantly declined in recent months, many chronic pain patients prescribed OxyContin® complain that the drug is noticeably less effective now that the new formulation has replaced the original on pharmacy shelves. This poses new challenges for Purdue Pharmaceuticals who are now faced with the daunting task of restricting abuse potential, while still providing substantial pain relief for patients.

References

1. T Cicero, J Inciardi, A Muńoz. Trends in Abuse of OxyContin® and Other Opioid Analgesics in the United States: 2002-2004. J of Pain Medicine. 2005;6(10):662-672.
2. Remoxy NDA. Drugs.com Website. http://www.drugs.com/nda/remoxy_101227.html. Accessed May 17, 2011.
3. B Setnik et al. The Abuse Potential of Remoxy®, an Extended-Release Formulation of Oxycodone, Compared with Immediate- and Extended-Release Oxycodone. J of Pain Medicine. 2011;12(4):618-631.