FDA may approve new medications that treat alcohol, nicotine, cocaine, and heroin addictions, but marketers must overcome the many challenges associated with selling them. Currently, only counseling and methadone treatment centers are available to help the United States' 14 million drug abusers-excluding cigarette smokers and alcoholics-stem their addictions. It's clear that new ways of treating sufferers are needed, as health and social costs associated with drug abuse correlate with rising addiction rates, according to NIH's Substance Abuse and Mental Health Services Administration (SAMHSA).
Among other challenges, addiction medicine marketers will need to balance their messages of the benefits of new products with reality. "There is no pill or box of tablets that can profoundly affect the drug addiction problem because it is so complicated," says Max Noble, managing director of Britannia, UK manufacturer of the heroin addiction treatment BritLofex (lofexidine). "Unfortunately, substance abusers are fairly unreliable regarding compliance. Companies shouldn't expect too much from a market where 80 percent of patients will relapse."
The United States can look oversees for experience in developing the addiction market, which several European companies have been doing for more than ten years. US companies have traditionally shied away from anti-abuse therapies because they wanted to avoid association with products that had the potential to be abused and used as street drugs-much like methadone. Also, as Zina Moukheiber wrote in a March 2001 Forbes article, "Treating crackheads doesn't quite fit the wholesome image pharmaceutical companies want to project."But the National Institute of Drug Abuse, prompted by the rising societal cost, has been working with several companies since the early 1990s to develop products that are less addictive than methadone and that use time-released delivery systems that render them "unabusable." Those products are finally coming down the pike.
Reckitt Benckiser's heroin addiction treatment buprenorphine is currently before FDA and is the most likely to be the first treatment to receive an indication for treatment of drug abuse.
The therapy "is the big one that everybody is waiting for," according to a source at SAMHSA, who attributes that receptivity to the product's efficacy and safety profile compared with methadone. Physicians can only prescribe buprenorphine, an opium derivative, because of a recent amendment to the 1914 Harrison Narcotics Act that allows doctors to dispense narcotic drugs to treat heroin addiction.
Physicians are so excited about the product's promise that training sessions, given by organizations such as the American Psychiatric Association, draw standing-room only audiences, reports the New Jersey Star Ledger series on addiction. In addition to that required training, physicians must be subspecialty board certified in addiction psychiatry or addiction medicine to prescribe it.
Schering-Plough will market buprenorphine in the United States if it is approved, but the company would not comment on its strategy. Physician promotion is likely to focus on education, and patient communications will direct addicts from treatment centers to their doctors' offices, which may have a profound effect on how drug abusers are cared for in the United States.
Nevertheless, delays in product approvals are likely. Kathleen Kohler, spokesperson for FDA's Division of Anesthetic Critical Care and Addiction Drug Products, says the agency doesn't have a committee dedicated to the review of addiction medications. Rather, the psycho-pharmacology drugs advisory committee is serving as a make-shift reviewer for at least one product, acamprosate, an alcoholism treatment developed by Merck KGaA.