HEROIN ADDICTS NOW HAVE ANOTHER CHOICE

Buprenorphine Wins OK From FDA For Treatment

Drug addicts trying to get off heroin now have another option to help them
kick the habit.

Federal Food and Drug Administration officials last week approved
buprenorphine for treating opiate addiction.

Used within provisions of the Drug Addiction Treatment Act of 2000, doctors
will be able to prescribe buprenorphine from their private offices, a shift
from the traditional approach to treating opiate addiction. Then-U.S. Rep.
Thomas J. Bliley Jr., R-Va., was a key backer of the legislation.

"Rather than having to go to a methadone maintenance program, which has
been the only way to get treatment up until this point, [addicts] now have
the option of going to their private doctor," said Dr. Elinore
McCance-Katz, chairwoman of the buprenorphine treatment committee of the
American Academy of Addiction Psychiatry.

"The problem has been that people who are addicted to opiates have a hard
time getting treatment at all. There are very limited treatment slots in
the United States," said McCance-Katz, chairwoman of addiction psychiatry
at Virginia Commonwealth University.

Methadone maintenance programs prescribe methadone, also an opiate and
subject to being abused, to addicts under strict monitoring and controls.
The programs usually dispense a single day's dose of methadone at a time,
which means people have to show up daily to get treatment.

The requirements can be inconvenient to people with jobs or to those who
don't live near a program. The stigma of going to a methadone clinic also
keeps people away, experts say.

"There are over a million or more heroin addicts in this country," said Dr.
George Bright, medical director of the Adolescent Health Center in Midlothian.

"About 200,000 are able to access methadone treatment. There are a
significant number of people who are not able to get treatment. In my
opinion, this will revolutionize the treatment of opiate dependency in this
country."

In Virginia, about 4,600 people are enrolled in publicly funded methadone
clinics, but state officials estimate the number of people addicted to
heroin and other opiates is 10 times that number. A few more might be in
private treatment clinics where other drugs are prescribed, but similar to
the national picture, most who need help are not getting it.

To prescribe buprenorphine from an office-based practice, physicians will
need training. They also will be limited in the number of patients they can
treat with the drug therapy.

Office-based treatment programs also must have counseling services
available for clients, Bright said.

Buprenorphine, which has been available for treating pain for some time,
underwent additional testing for the new use.

"Ten years of good, solid science has finally come to fruition," said
Charles O'Keefe, president of Reckitt Benckiser Pharmaceuticals, the
Chesterfield County company that makes the drug.

However, not everyone supported the drug's expanded use.

In December, a Washington law firm representing an undisclosed client asked
the FDA to delay action until more information was made available for
public review. The petition also pointed to buprenorphine overdose deaths
in France as evidence of potential problems in the United States.

Buprenorphine will be sold under the names Subutex and Suboxone, which
includes an additional drug, naloxone, added to lessen the drug's potential
to be abused.

"They can't abuse the drug by injection," said McCance-Katz. "They will get
sick if they do."

Subutex, FDA documents say, is intended for the initial stage of treatment.
Suboxone is intended for the maintenance stage.

Because there have been concerns that the drugs might be abused, federal
officials plan to keep an eye on what happens once the drug becomes
available, which could be in a few months. That surveillance will include
interviewing substance abusers, monitoring local drug markets and reviewing
reports of adverse drug outcomes.