Approved: June 17, 2011 1
Oxecta is an immediate-release tablet formulation of oxycodone that
is now available in 5 mg and 7.5 mg tablets. A noteworthy difference between Oxecta and other
oxycodone products is the use of new technology designed to discourage common methods of tampering
that may help to decrease opioid abuse and misuse 2. The FDA is requiring Pfizer to complete a post-approval study to see whether there
is actually a decrease in misuse and abuse 3.
Acura Pharmaceuticals has a patent on Aversion Technology (abuse
deterrent products) used in Oxecta. Aversion Technology aids in discouraging misuse and abuse
of pharmaceutical products by three common ways: intravenous injection, nasal insufflations, and
intentional ingestion of excess quantities of tablets or capsules. When a drug abuser tries
to extract the active ingredient to something suitable for intravenous injection, Aversion
Technology creates a viscous gel mixture, trapping the active ingredient inside. The one
downside is it is still possible with great difficulty to draw the gel mixture through a needle.
If a prospective abuser tries to crush or grind the tablets or capsules in order to attempt
to insufflate the resulting mixture, Aversion Technology works by eliciting a burning, irritating
sensation in the nares 4
Though not used in Oxecta, some Aversion products work by
adding niacin into certain formulations causing a general feeling of discomfort in a person trying
to swallow a large quantity of medication. The only Aversion product utilizing this method is
Acurox with niacin. This product is currently in Phase III trials 4.
Other products in the pipeline with Aversion Technology are Acuracet
(oxycodone HCl/APAP) and Vycavert (hydrocodone bitatrate/APAP) which are both in the formulation and
stability phase and Impeded PSE (pseudoephedrine HCl), also awaiting approval 4.
- "Drug Details (Oxecta)." Drugs@FDA. US
Department of Health and Human Services. Web. 2 Aug. 2011.
- Oxecta [package insert]. Acura
Pharmaceuticals Inc., Palatine, Illinois; June 2011.
August 2, 2011.
- RAPPAPORT, Bob A. "New Drug Application (Oxecta)."
Letter to King Pharmaceuticals Research and Development, Inc. 17 June 2011. Food and
Drug Administration. US Department of Health and Human Services, 17 June 2011. Web. 2 Aug.
Technology | Acura Pharmaceuticals." Abuse Deterrent Products by Acura
Pharmaceuticals. Web. 02 Aug. 2011. .