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FDA Approves Two Forms of Buprenorphine for Opiate Treatment
By Bob Curley
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Congress Cleared the Way
Buprenorphine advocates have been restlessly awaiting FDA approval almost
from the moment that Congress passed the Drug Abuse Treatment Act of 2000
(DATA), which cleared the way for doctors to prescribe anti-opiate
medications in their offices, rather than limiting treatment to methadone
clinics.
Buprenorphine received ringing endorsements from the U.S. medical
community and researchers, including CSAT, the National Institute on Drug
Abuse (NIDA), and ASAM. But the extended FDA review process, coupled with
active opposition from some methadone treatment providers, led many in the
field to question whether buprenorphine would ever be approved.
Some blamed the delay on methadone providers who petitioned the FDA to
subject buprenorphine to further review. One unnamed opiate treatment
provider asked the DEA in May to list buprenorphine as a Schedule II
substance, citing the drug's potential for abuse.
But the petition filed with DEA also reveals what critics say is the true
reason for resistance by some methadone clinics: money.
"Methadone clinics treat both new patients and patients who have been
stabilized to methadone," a legal brief filed on behalf of the anonymous
treatment program stated. "As a general matter, the latter group provides
economic stability to the program. The former group exacts a
disproportionate economic toll on the program. However, it is the
stabilized patient group that is most likely to be eligible for
buprenorphine treatment and, therefore, is the most likely to leave the
program in favor of office-based treatment."
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"The intentional placement of buprenorphine in Schedule III 'to expand
narcotic treatment' to physicians offices will have a significant impact
on opioid treatment programs," the brief concluded.
Parrino said...»»
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