FDA Recognizes OxyContin Abuse With New Reformulation

FDA Recognizes OxyContin Abuse With New Reformulation

April 23rd, 2013 // 4:18 pm @

Updated Daily – Read our latest FDA, cGMP Compliance News

The FDA approval in recent weeks of a new abuse-resistant form of OxyContin is being seen by many in the pharmaceutical industry as a good indication of the agency’s awareness of the significant growth of OxyContin abuse to even an epidemic status.

The abuse of OxyContin has been a big problem in the US. About 7% of users in 2011 got it from a doctor, and 13% bought it from a dealer. At this time, about 10% of the US population abuses the opiate at some point in their lifetime. The new OxyContin product changes some of the physical and chemical aspects of the drug. It makes it harder to abuse it through intranasal administration.

FDA also has outlawed all ANDAs or generics that are based upon the approval of the old OxyContin.

In the past, the manipulation, crushing, breaking and dissolving of OxyContin could cause a faster absorption of the drug and could help some users to achieve a euphoric high. However, research has shown that manipulation of the drug also can cause overdose or death.

It is thought that the development of a new reformulation of the drug can potentially save lives that are being lost senselessly each year due to the abuse of the drug.

It appears that the manipulation that was possible of the old OxyContin is less likely with the new drug. According to Deputy Director for Regulatory Programs at CDER – Douglas Throckmorton – the development of opiod analgesics that are resistant to abuse are a high priority for FDA. FDA believes that the new OxyContin will make injection abuse difficult and it will make it harder to snort, as well.

Given that there was such a  high level of abuse of the old drug, would it possibly be a good idea for FDA to think about reformulating other drugs that are being abused as well?


Subscribe Now

Testimonial

"ExpertBriefings.com always selects excellent speakers – some of the best I have ever heard. Their messages are direct, clear, timely, and relevant."

Anon A. Mouse

Featured Partner