FEDS REVIEW OXYCONTIN TREATMENT

Health Canada is reviewing a new treatment for OxyContin addiction that has
received promising assessments since its approval in the U.S. some 18
months ago.

The new formulation of the drug buprenorphine -- marketed under the brand
name Suboxone -- is not approved for use in Canada.

"The only thing I can tell you right now is that I can confirm the file is
currently under review by Health Canada," said Randy Steffan, a spokesman
for pharmaceutical giant Schering-Plough, which holds the drug's marketing
rights in Canada. "I can't comment any further on its status. We're hopeful
a decision will be made soon."

Suboxone is considered more accessible than methadone, because it can be
prescribed in pill format.

Those being treated with methadone must visit a clinic every day.

Buprenorphine was approved in Canada years ago for pain control, but was
never launched. At that time, it was not a Schering-Plough product, Steffan
said.

The current review is examining buprenorphine's potential use in treating
addiction to opiates such as OxyContin.

Steffan wouldn't say how long that Health Canada review has been ongoing.
"We don't really discuss details of a file while it's under regulatory review."

Jirina Vlk, a spokeswoman for Health Canada, said the federal agency is not
permitted to confirm or deny that a specific drug is under review.

But Vlk did say that, in general, there are two types of review processes
to approve drugs for use in Canada.

The target review period for non-priority drugs is 300 days. For priority
drugs -- those which can potentially be life-saving -- that review target
drops to 180 days.

Two buprenorphine formulations -- under the brand names Subutex and
Suboxone -- were approved by the U.S. Food and Drug Administration (FDA) in
2002 for use in addictions treatment.

Subutex contains only buprenorphine, and is intended for use during only
the first few days of treatment for drug abuse, the FDA said in an October
2002 news release.

Suboxone is used for maintenance treatment of addiction.

Suboxone contains an additional ingredient intended to guard against
intravenous abuse of the drug.

The drugs were studied in over 2,000 patients and shown to be safe and
effective, the FDA said.

They aim to prevent withdrawal symptoms like nausea and agitation.

The FDA considers buprenorphine a lower risk for causing dependence than
OxyContin or methadone.

Buprenorphine is the first such treatment approved in the U.S. that can be
prescribed in a doctor's office, according to the FDA.

Doctors must get special training to prescribe the drug, and a cap is in
place on the number of patients they are allowed to treat with it.

There are currently about 60,000 patients using Suboxone in the U.S.,
according to officials with Reckitt Benckiser, which owns the rights to the
drug there.

An estimated six million people in the U.S. are dependent on opiates -- 1.5
million are hooked on heroin, the rest on prescription painkillers like
OxyContin.

The low number of people currently being treated with Suboxone is a
reflection on the specialized training doctors need to prescribe the drug,
said Shaun Thaxter, Reckitt Benckiser's vice-president of marketing.

"I don't think that it's so much reluctance (to use Suboxone) as a need for
physicians to take some very specific training in order to qualify to treat
these patients," Thaxter said in a recent interview.

It's that accessibility that makes Suboxone a "revolutionary opportunity"
for patients, he said.

"The reason that Suboxone offers something new is the fact that you can get
it in your local doctor's office," Thaxter noted.

"Because (addiction) is a common disease affecting ordinary people, it's
appropriate to treat this in the privacy of your local doctor's office."

Suboxone has the potential to make it easier to treat patients in rural
areas, Thaxter said, where daily access to methadone may not be readily
available.

"For the first time, doctors now can help patients regain control over
their lives," Thaxter said. "And that really is what the value is -- to put
you, as the patient, back in control of your dependence.

"So, instead of you spending the whole time craving this drug, having to
change your lifestyle to focus on getting the drug every day, those
cravings are taken away =85 and you can now get on with your life."

On the downside, buprenorphine costs much more than methadone -- as much as
10 times more, according to The Medical Letter, a U.S.-based non-profit
organization that offers critical appraisals of drugs.

Buprenorphine has also been the subject of largely positive mainstream
media reports south of the border.

In a story earlier this month, the New York Times called it "the first of a
new generation of prescription drugs that is changing the landscape of
addiction treatment, providing new hope and moving addiction from clinics
and rehab centres, long seen as magnets for junkies, pushers and gloom,
into the comfort of the doctor's office."

The Times story quoted Dr. Alan I. Leshner, a former director of the
National Institutes of Drug Abuse: "Buprenorphine is the most important
advance, certainly in heroin and opiate treatment, if not all addiction
treatments in the last 30 years."

The prescription painkiller OxyContin -- and the social havoc its abuse can
wreak -- was the subject of a recent task force in this province.

`Drug of choice' for abusers

According to the task force report, released earlier this month, police
have been monitoring OxyContin as the "drug of choice" among Newfoundland
street users for about two years.

OxyContin is directly linked to six of the province's 17 accidental
overdose deaths since 1997.

The Royal Newfoundland Constabulary (RNC) recently blamed a spike in
property crime rates on the local drug trade. Residential and commercial
break and entries are up roughly 30 per cent so far this year compared to
2003, and the number of armed robberies has doubled.

"We've been able to determine that a lot of the stolen property is being
used as an exchange for drugs," RNC spokeswoman Staff Sgt. June Layden told
The Telegram in July.

The Williams administration is now reviewing the 50 recommendations of the
OxyContin task force.

Five of those 50 recommendations deal with the potential use of methadone
to treat OxyContin addiction.

There are currently 14 doctors in Newfoundland and Labrador who have
exemptions to prescribe methadone, according to Dr. Robert Young, registrar
of the Newfoundland Medical Board.

Only four of those exemptions are for the treatment of addiction. The
others mainly deal with palliative care and pain management for specific
patients.

As for buprenorphine, the provincial Department of Health can't comment on
any drug yet to be approved for use in Canada, spokeswoman Carolyn Chaplin said.