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FOR IMMEDIATE RELEASE
International Patent Application To Be
Published on Abuse-Resistant
Pain Reliever Being Developed by Purdue Pharma
Stamford, CT, August 8, 2001 – Purdue
Pharma L.P. expects to receive notification soon of the publication
of an international patent application for a pharmaceutical
formulation that combines an opioid pain reliever with a
“sequestered antagonist” that would work to help prevent the
medication from being abused.
Purdue Pharma is concerned about increased reports of abuse of its
pain medication, OxyContin® (controlled release oxycodone HCl)
Tablets. As part of a comprehensive program of initiatives to combat
this serious problem, the company has been investing tens of
millions of dollars in research and development into pain relievers
that are more resistant to abuse. Preliminary results appear to show
some progress, according to Dr. Paul Goldenheim, Executive Vice
President, Worldwide Research and Development.
“One of our recent efforts focuses on the use of an antagonist to
block the effect of the opioid if it is abused,” says Goldenheim.
“When appropriately taken by a pain patient, the tablet is swallowed
whole, and the antagonist should pass through the gastrointestinal
system of a patient without significant release. Preliminary in
vitro studies to date have demonstrated that the release of the
antagonist from the intact dosage form is minimal (<5% of total
after 36 hours). When the dosage form is tampered, such as by
crushing, in vitro results show that the entire amount of antagonist
is released, thus potentially causing an undesirable effect to the
abuser. If these results can be confirmed in clinical studies, this
will be a significant technical achievement.”
Drug abusers have learned to defeat the time-release properties of
certain long-acting opioid analgesics, including OxyContin, by
compromising the delivery system and then snorting or injecting them
to achieve a “high.”
“If this tablet is abused, preliminary in vitro studies show that it
behaves in a completely different way,” Dr. Goldenheim continues.
“Crushing the tablet to defeat its time-release properties also
releases the antagonist, which blocks the effects of the opioid.
Abusers will not experience euphoria and may experience the
uncomfortable effects of withdrawal. We hope that knowledge of the
tablet's abuse-resistant properties will deter potential drug
abusers from even trying this product.”
While this abuse resistant pain reliever is still in the
experimental phase of development, Purdue is planning to begin
clinical trials early next year.
This research effort is part of Purdue’s ten-point plan to reduce
prescription drug abuse, while ensuring that legitimate patients
continue to have access to the medications they need. Other elements
of the program include an educational program alerting teenagers and
pre-teens about the dangers of prescription drug abuse, the
provision of free tamper-resistant prescription pads and educational
materials that help physicians and pharmacists reduce prescription
drug diversion, and sponsorship of hundreds of medical education
programs to educate healthcare professionals about proper pain
management. The company is also working with law enforcement to curb
diversion of prescription drugs through theft and fraud.
The labeling for OxyContin contains the following warning 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 web site at
http://www.pharma.com/news/docs/oxyPackageInsert.pdf.
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