Abuse resistant oxycodone clears trial

Related tags Pharmacology

The results of a new clinical trial provide evidence that Durect's
Oradur delivery technology can reduce the risk of misuse or abuse
of narcotic painkillers.

The trial, carried out by Pain Therapeutics, was conducted on Remoxy (oxycodone), a novel drug candidate specifically designed to deter abuse of the drug, which is twice as potent as morphine.

Oxycodone is the active ingredient in Purdue Pharma's OxyContin, a branded, controlled release narcotic painkiller with annual sales exceeding $1.5 billion that has been the subject of a number of cases of diversion and abuse, according to the US Food and Drug Administration (FDA).

Reports have indicated that abusers crush OxyContin tablets and snort the powder or dissolve it in water or alcohol (vodka apparently being a preferred medium) and inject it to defeat the controlled-release effect of the formulation and attain a "rush" or "high" through the resulting rapid absorption of the drug. It is estimated that this abuse is associated with several hundred deaths a year in the US.

Remoxy is an oral, long-acting oxycodone capsule that incorporates several abuse-deterrent properties and offers the convenience of twice-a-day dosing. Initial tests indicate that crushing or physically manipulating Remoxy does not breach its long-acting mechanism. Remoxy can also resist extraction by acids or alcohol for hours at a time by entrapping a majority of its oxycodone inside the Oradur formulation.

ORADUR is a sustained release technology (formerly referred to as the SABER oral gel-cap technology) that takes the form of a gelatin capsule that uses a high-viscosity base component, sucrose acetate isobutyrate (SAIB), used to provide controlled release of active ingredients over a period of 12 to 24 hours.

In a head-to-head clinical comparison of the two drugs, OxyContin released over 200 per cent more drug than Remoxy in an abuse study in high-proof alcohol and over 170 per cent more drug in a chewing study in the first hour of the studies (when abusers presumably expect to get high). The trial also showed that Remoxy is bioequivalent to OxyContin, meaning the two drugs provide similar levels of oxycodone in people when used as intended.

Meanwhile, federal and state agencies in the US and Purdue have taken actions to address the abuse and diversion of OxyContin. The FDA approved a stronger safety warning on OxyContin's label, and the agency and Purdue have collaborated on a risk management plan to help detect and prevent OxyContin abuse and diversion, an approach that was not used at the time the drug was approved in 1995.

The FDA also plans to provide guidance to the pharmaceutical industry by September 2004 on risk management plans, which are an optional feature of new drug applications.

"OxyContin abuse is directly related to how easily and quickly abusers can manipulate or destroy the drug's time-release mechanism,"​ according to Lynn Webster, medical director of the Lifetree Pain Clinic in Salt Lake City and a specialist in addiction medicine. "Anything that denies abusers this opportunity is a significant breakthrough in oxycodone therapy."

At last year's CPhI exhibition, resins specialist Rohm and Haas unveiled its own answer​ to the OxyContin abuse problem. Reduced Abuse is based on the use of ion exchange resins that trap the active drug in a matrix.

Related topics Ingredients Delivery technologies

Related news

Show more

Related products

Pulmonary Delivery of Orally Inhaled Therapeutics

Pulmonary Delivery of Orally Inhaled Therapeutics

Content provided by Catalent Pharma Solutions | 19-Oct-2023 | Business Advice

New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small...

Related suppliers