OXYCONTIN maker getting patent to reformulate often-abused drug

Wednesday, August 8th 2001, 12:00 am
By: News On 6

ROANOKE, Va. (AP) -- The maker of OxyContin, a prescription
painkiller linked to a growing number of overdoses and deaths, said
Wednesday that it has come up with blueprints for a "smart pill"
that would be tougher to abuse.
The new painkiller, which has yet to be named and would not be
available for at least three years, would destroy its own narcotic
ingredients if crushed into a powder and snorted or injected -- the
typical manner in which OxyContin currently is abused.
"Addicts and abusers are going to find this very undesirable,"
said Dr. J. David Haddox, senior medical director for Purdue Pharma
LP of Stamford, Conn. "Before long they're going to say, 'Don't
mess with that stuff; that's no good."'
Purdue spokesman Jim Heins said the drug could become an
alternative to their top-selling painkiller in areas like rural
Appalachia where prescription drug abuse is especially high.
OxyContin is a slow-release narcotic painkiller that is widely
prescribed for victims of moderate to severe chronic pain resulting
from such problems as arthritis, back trouble and cancer. One pill
is designed to last 12 hours, but abusers usually crush the
medicine and then snort or inject it, producing a quick,
heroin-like high.
The drug has been blamed for contributing to more than 100
deaths nationwide. Purdue, which has become the target of at least
13 OxyContin-related lawsuits in five states, says those estimates
are unreliable and that in the vast majority of those cases, the
victims were abusing other drugs at the same time.
Like OxyContin, which was introduced in December 1995, the new
drug would be for victims of moderate to severe chronic pain.
However, it would be embedded with microscopic "beads" of
naltrexone, a narcotic antagonist that counteracts the medicine.
The beads would be coated with a chemical to keep them from
dissolving, so the pain medication will work just like OxyContin if
taken as directed.
But if the pill is crushed or chopped up, the coating on the
beads would break, releasing the naltrexone and canceling the
drug's effects, Haddox said.
Purdue is still conducting tests on the new drug, which could be
ready in three years. Officials have not decided yet whether to
make oxycodone the active ingredient, or to include a different
narcotic altogether, like morphine.
If the Food and Drug Administration approves the drug, it would
be one of only a few abuse-resistant drugs on the market. The first
smart pill, a painkiller called Talwin NX, uses an antagonist
called naloxone to achieve similar effects.
Richard S. Weiner, executive director of the American Academy of
Pain Management in Sonora, Calif., applauded the new formula.
"Hopefully, this will assuage law enforcement that ...
painkillers can be safe," Weiner said.
Purdue has been criticized for not reformulating OxyContin to be
like Talwin. Company officials decided against doing so, Haddox
said, because they were concerned that naloxone might create a
"ceiling" effect in OxyContin. Such a drug would not increase in
potency past a certain point, even if a patient takes higher and
higher doses.
"We think this is a much more elegant solution to the
problem," Haddox said.
Purdue officials said the timing of the patent has nothing to do
with lawsuits from people claiming they're addicted to OxyContin
and others who want to hold the company responsible for illicit
abuse of the drug.
This week, Purdue said it expects an international patent
application will be published on their "sequestered naltrexone"
technology, an initial step that expedites the formula protection
process in some countries. Heins said the company also will seek
individual patents in the United States, Japan, Europe and other
major market.