Best Evidence Analyses and Commentary

Array ( [a] => displayArticle [aFeedID] => 2815 [aArticleID] => 21540 [aCID] => 240 [aAID] => 0 [DF] => THSBDA [DT] => P ) Notice: Undefined index: n in /home/mutualgravity/public_html/archangel/feedengine/content.php on line 16 Notice: Undefined index: so in /home/mutualgravity/public_html/archangel/feedengine/content.php on line 17 Notice: Undefined index: sh in /home/mutualgravity/public_html/archangel/feedengine/content.php on line 18
Oxecta Approved
New abuse-resistant oxycodone formulation
Gabriella Lucarelli, PharmD Candidate, 2012

Oxecta (oxycodone)

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.

 

  1. "Drug Details (Oxecta)." Drugs@FDA. US Department of Health and Human Services. Web. 2 Aug. 2011.
  2. Oxecta [package insert]. Acura Pharmaceuticals Inc., Palatine, Illinois;  June 2011.

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202080s000lbl.pdf. Accessed August  2, 2011.

  1. 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. 2011.
  2. "Aversion® Technology | Acura Pharmaceuticals." Abuse Deterrent Products by Acura Pharmaceuticals. Web. 02 Aug. 2011. .

Website Terms of Use Disclaimer | E-mail Terms of Use | Contact LECOM | RSS | Copyright © 2009 LECOM - All rights reserved