Oxycodone (Trade Names: Tylox, Percodan, Oxycontin)

Introduction

Oxycodone abuse has been a continuing problem in the United States since the early 1960's. In passing the Comprehensive Controlled Substances Act of 1970, Congress placed oxycodone in Schedule II. In spite of its CII status, oxycodone continued to be abused. The abuse of a new sustained-release formulation of oxycodone, known as Oxycontin®, has escalated over the last year. Drug abuse treatment centers, law enforcement personnel, and pharmacists have recently reported a sudden increase in the abuse of these sustained release products in Maine, Virginia, West Virginia, Ohio, Kentucky and Maryland. The estimated number of emergency department episodes involving oxycodone were stable from 1990 through 1996. However, the number of ED episodes doubled from 1996 to 1999: 3,190 episodes in 1996 to 6,429 in 1999.

Licit Uses

Oxycodone is an effective analgesic for mild to moderate pain control, chronic pain syndromes, and for the treatment of terminal cancer pain. Five mg of oxycodone is equivalent to 30 mg of codeine when administered orally. Oxycodone and morphine are equipotent for pain control in the normal population; 10 mg of orally-administered oxycodone is equivalent to 10 mg of subcutaneously administered morphine. Oxycodone is considered to be in all respects morphine-like and, in spite of the chemical relationship to codeine, closer to morphine than to codeine in its dependence liability.

Chemistry/Pharmacology

Oxycodone [4,5a-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one; dihydrohydroxycodeinone] is a semisynthetic opioid structurally related to codeine and is approximately equipotent to morphine in producing opiate-like effects. The first report that oxycodone, sold under the brand name Eukodal, produced a "striking euphoria" and habituation symptoms was published in Germany in the 1920's. While oxycodone is metabolized by the liver to oxymorphone, the physiological and behavioral effects are not related to, nor dependent on, the formation of this metabolic by-product.

Oxycodone will react as a normal opiate in the available field test kits.

Illicit Uses

Oxycodone is abused for its opiate-like effects. In addition to its equipotency to morphine in analgesic effects, it is also equipotent to morphine in relieving abstinence symptoms from chronic opiate (heroin, morphine) administration. Many dose forms are available. Oxycodone’s behavioral effects can last up to 5 hours. The sustained-release formula has a longer duration of action (8-12 hours). The drug is most often administered orally. A recent study comparing controlled released products containing oxycodone (Oxycontin) and morphine (MS Contin) reported that Oxycontin was twice as potent as MS Contin. The growing awareness and concern about AIDS and blood-borne pathogens easily transmitted by syringe needle use, has made the oral bioavailability of Oxycodone attractive to the typical opiate abuser.

As with most opiates, the adverse effects of oxycodone abuse are dependence and tolerance development. Oxycodone’s co-formulation with acetaminophen has also increased the likelihood of acetaminophen-induced hepatic necrosis with chronic dosing. Its availability in sustained release formulations has increased the dosage forms from 10 to 160 mg per tablet making it more attractive than Oxycodone to opiate abusers and doctor-shoppers. While the original idea of polymer-formulations of oxycodone was to reduce the likelihood of misuse with high dose formulations, opiate abusers quickly learned the ease of extraction of the molecule from the polymer formula and have been injecting or snorting the dissolved tablets in spite of the polymerization and because of its’ higher dosage formulations.

User Population

Every age-group has been affected by the relative ease of oxycodone availability and the perceived safety of these products by professionals. Sometimes seen as a "white-collar" addiction, oxycodone abuse has increased among all ethnic and economic groups.

Illicit distribution

Oxycodone-containing products are in tablet, capsule and liquid forms. A variety of colors, markings, and packaging are available.

The major source of oxycodone to the street has been through forged prescriptions, professional diversion through unscrupulous pharmacists, doctors, and dentists, "doctor-shopping", and large-scale thefts. Oxycodone sells for $0.50 to $1.00 per milligram. A 40 mg tablet is sold for $25-$40, and the 80 mg tablets are being sold for $65-$80. The more recent 160 mg tablets do not have a stable price at this time, but sell for in excess of $100 per tablet.

Control status

The Controlled Substances Act of 1970 has categorized oxycodone products in Schedule II.

Information provided by the U.S. Department of Justice, Drug Enforcement Administration, Diversion Control Program.

Comments and additional information are welcomed by the Drug and Chemical Evaluation Section,
FAX 202-307-8570 or telephone 202-307-7183.

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