Buprenorphine Approved by US FDA for Opiate Addiction Treatment
Oct 8, 2002
Originally Published in TRIP
On October 8, 2002, the Food and Drug Administration (FDA) gave final approval for the use of two buprenorphine-containing products to be marketed and sold as opiate addiction and withdrawal treatments. After several years of pressure from doctors, addicted opiate users, and harm reduction groups, this promising new treatment is available for use in the US.
Basically, the DEA and USDOJ and US Dept of Health & Human Services has loosened the restrictions on Buprenex. Doctors had been "shut down" by strong-armed DEA agents, and immediately stopped prescribing it in the State of Texas for about 9 months have finally been able to start prescribing again under certain circumstances and rules.
The efficacy for Buprenorphine is surprising and could be called a "miracle drug" for many people addicted to opiates. It can speed 'detoxification' (going from daily use to no use) and reports are that it can take users from extremely heavy levels of dependence to zero without serious withdrawal. For decades, the US medical community hasn't had many weapons against opiate addiction. One of the primary medications used is Methadone, which still leaves the patient addicted to an opiate!
It helps those who really don't want to take opiates anymore a "parachute" by which they can function as a normal healthy human being while tappering down, and remove ALL withdrawls and cravings that usually lead people back after short periods of abstinence.
- FDA's formal declaration of approval of addiction-treatment use of Buprenorphine
- FDA's FAQ's on Subutex / Suboxone
- Drug label (FDA Publication)
- Patient Leaflet (FDA Submission)
- Physician Information & FAQ's (FDA Publication)
- Pharmacists Information & FAQ's (FDA Publication)
- Petition to FDA requesting approval
Basically, the DEA and USDOJ and US Dept of Health & Human Services has loosened the restrictions on Buprenex. Doctors had been "shut down" by strong-armed DEA agents, and immediately stopped prescribing it in the State of Texas for about 9 months have finally been able to start prescribing again under certain circumstances and rules.
The efficacy for Buprenorphine is surprising and could be called a "miracle drug" for many people addicted to opiates. It can speed 'detoxification' (going from daily use to no use) and reports are that it can take users from extremely heavy levels of dependence to zero without serious withdrawal. For decades, the US medical community hasn't had many weapons against opiate addiction. One of the primary medications used is Methadone, which still leaves the patient addicted to an opiate!
It helps those who really don't want to take opiates anymore a "parachute" by which they can function as a normal healthy human being while tappering down, and remove ALL withdrawls and cravings that usually lead people back after short periods of abstinence.