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;
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. .