For Release October 9, 2002
Buprenorphine, a new medication developed through more than a decade of research supported by the National Institute on Drug Abuse (NIDA), will now become available to treat heroin and other opioid dependence through certification and training of physicians to use the medication by the Substance Abuse and Mental Health Services Administration (SAMHSA).
Buprenorphine will be able to be used by physicians in office-based treatment, as long as physicians have the minimum eight hours of training mandated by Congress and obtain a waiver that allows them to prescribe certain controlled substances . Buprenorphine was approved last night for treatment of opioid dependence by the Food and Drug Administration. This medication will not replace methadone therapy, provided through special methadone treatment facilities, but will provide the office-based physician an opportunity to treat patients for addiction to heroin or other opioids, including prescription pain-killers. Physicians will be required to refer patients to full-spectrum care for their social and psychological needs.
"This is a major step forward toward improving and broadening treatment options for individuals addicted to opioids," said Dr. Glen Hanson, Acting NIDA Director. "Buprenorphine is an important new treatment tool. Not only will it expand availability of treatment, but its method of administration and dosing schedule will make it more likely that recovering addicts will be more likely to adhere to the treatment regimen."
"Buprenorphine will allow patients to be treated for addictions in the same manner as they are treated for other chronic illnesses, such as diabetes or hypertension," said SAMHSA Administrator Charles G. Curie. "A qualified physician will be able, for the first time, to prescribe an anti-addiction medication in an office setting and treat opiate addiction as any other chronic disease."
Buprenorphine's unique effects and pharmacology make it an attractive and clinically helpful treatment option. Buprenorphine is related to morphine, but is a partial agonist that functions on the same brain receptors as morphine, but does not produce the same high, dependence or withdrawal syndrome. It is long-lasting, less likely to cause respiratory depression, and well-tolerated by addicts.
Buprenorphine represents a milestone in NIDA's medication development program. Buprenorphine is the second medication to come out of NIDA's 12-year investment in this program and many more compounds are under development. The first medication to come out of the program was LAAM (1-alpha-acetyl-methadol), which was approved in 1993 for the management of opiate dependence.
Buprenorphine will join methadone, naltrexone and LAAM as the fourth medication available for treating heroin and other opiate addictions.
Physicians who are not addiction medicine specialists, and who want to offer this new option to their patients, must first complete an eight-hour training session to qualify for a waiver from the Controlled Substances Act 21[USC 823(g)], which restricts the use of methadone and other opiate drugs to federally licensed addiction treatment clinics. The waiver permits primary care physicians to provide office-based treatment. To date, approximately 2,000 physicians have received training.
In the next few months, SAMHSA will establish a nationwide registry of physicians holding this waiver to assist health care workers and patients identify qualified treatment professionals for detoxification (weaning off heroin) or maintenance (keeping off heroin) of as many as 30 patients. It is estimated that there were 898,000 chronic heroin users in the United States in 2000.
To encourage physicians to participate in buprenorphine training sessions and to inform the public about this new treatment option, SAMHSA/CSAT will be launching an information campaign in the near future. This campaign will kick-off in Washington, DC and roll-out to cities across the United States including: Baltimore, MD; Boston, MA; Chicago, IL; Dallas, TX; Detroit, MI; Miami, FL; New Orleans, LA; Newark, NJ; New York, NY; Portland, OR; Salt Lake City.
SAMHSA has set up an information website and toll free number for physicians to call for information. Physicians can get more information from www.buprenorphine.samhsa.gov or by calling the SAMHSA Buprenorphine Information Center at 866-BUP-CSAT from 8:30 A.M. to 5:00 P.M.,EST.
The National Institute on Drug Abuse is a component of the National Institutes of Health, U.S. Department of Health and Human Services. NIDA supports more than 85 percent of the world's research on the health aspects of drug abuse and addiction. The Institute carries out a large variety of programs to ensure the rapid dissemination of research information and its implementation in policy and practice. Fact sheets on the health effects of drugs of abuse and further information on NIDA research can be found on the NIDA web site at http://www.drugabuse.gov.
SAMHSA, a public health agency within the U.S. Department of Health and Human Services, is the lead federal agency for improving the quality and availability of substance abuse prevention, addiction treatment and mental health services in the United States. Information on SAMHSA's programs is available on the Internet at www.samhsa.gov.