FOR IMMEDIATE RELEASE
Purdue
Pharma Begins Clinical Studies of Abuse-Resistant Pain Medication
Stamford, CT, December
3, 2001 — Purdue Pharma L.P. has begun clinical studies of a new
pharmaceutical product combining the opioid analgesic oxycodone in a
controlled-release formulation with an opioid antagonist, naloxone. This
product is designed to reduce intravenous abuse of OxyContin® (oxycodone
HCl controlled-release) Tablets. Following completion of the clinical
trials, the company will prepare a New Drug Application (NDA) for
submission to the U.S. Food and Drug Administration (FDA) seeking
clearance to market the medication.
“It is a complex task to develop multiple formulations with different
amounts of controlled-release oxycodone combined with an antagonist,” says
Dr. Paul Goldenheim, Executive Vice President, Worldwide Research and
Development. “While it is difficult to predict when this product might be
available to patients, we are working closely with FDA and are planning to
file the NDA before the end of next year.”
Drug abusers have learned to defeat the time-release properties of
OxyContin, by compromising the drug’s delivery systems by chewing,
snorting, or injecting the medication to achieve a euphoric “high.” When
taken as directed, the oxycodone-naloxone tablet is intended to be
swallowed whole, and the small amount of naloxone should not adversely
affect the patient or interfere with the analgesic effect of the oxycodone.
However, if the tablet were to be crushed and injected, the naloxone would
be released into the blood, where it would counteract the effect of the
oxycodone — thereby diminishing the euphoria the abuser is seeking and
potentially subjecting the abuser to undesirable withdrawal symptoms.
Purdue has made the development of abuse-resistant pain medications its
number one research priority. To date the company has committed more than
$50 million to these research efforts. In August, Purdue announced the
publication of an international patent application for a new drug
formulation combining an opioid pain reliever with another antagonist,
naltrexone, which is intended to reduce oral and intranasal abuse.
These research efforts are part of a multifaceted plan developed by Purdue
Pharma to reduce prescription drug abuse while ensuring that pain patients
continue to have access to the medications they need. Other elements of
the program include educational programs and materials that teach
healthcare professionals about proper pain management and how to recognize
and reduce prescription drug diversion, offering free tamper-resistant
prescription pads to help curb prescription fraud, and an educational
program alerting teenagers and pre-teens about the dangers of prescription
drug abuse.
The labeling for OxyContin contains the following warnings for patients
and physicians:
OxyContin is an opioid agonist and a Schedule II controlled substance with
an abuse liability similar to morphine.
Oxycodone can be abused in a manner similar to other opioid agonists,
legal or illicit. This should be considered when prescribing or dispensing
OxyContin in situations where the physician or pharmacist is concerned
about an increased risk of misuse, abuse, or diversion.
OxyContin Tablets are a controlled-release oral formulation of oxycodone
hydrochloride indicated for the management of moderate to severe pain when
a continuous, around-the-clock analgesic is needed for an extended period
of time.
OxyContin Tablets are NOT intended for use as a prn analgesic.
OxyContin 80 mg and 160 mg Tablets are for use in opioid-tolerant patients
only. These tablet strengths may cause fatal respiratory depression when
administered to patients not previously exposed to opioids.
OxyContin Tablets are to be swallowed whole and are not to be broken,
chewed, or crushed. Taking broken, chewed, or crushed OxyContin Tablets
leads to rapid release and absorption of a potentially fatal dose of
oxycodone.
Full prescribing information for OxyContin Tablets can be found online at
the Purdue website at
http://www.purduepharma.com/news/docs/oxyPackageInsert.pdf.
More information is available on Purdue Pharma’s website at
www.purduepharma.com.
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