The FDA has added opioid dependence as an indication for long-acting naltrexone (Vivitrol), a once-monthly injectable.
The drug, already approved to treat alcohol dependence, joins the short list of pharmacologic treatments for opioid addiction, including methadone and buprenorphine.
"We are always happy to have another addition to our arsenal of addiction treatment," said Petros Levounis, MD, of St. Luke's and Roosevelt Hospitals in Manhattan.
"Addiction is a serious problem in this country and can have devastating effects on individuals who are drug-dependent and on their family members and society," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "This drug approval represents a significant advancement in addiction treatment."
Naltrexone is an opioid antagonist, blocking any of the feelings patients expect when they take heroin, morphine and other opioids.
That action differs from those seen with methadone, an opioid agonist used as replacement therapy, and buprenorphine, a partial agonist that blocks most opioid receptors while giving the patient just a taste of opioid effects. (See Barriers Remain for Primary Care Treatment of Addicts)
Vivitrol, like short-acting naltrexone and buprenorphine, can be prescribed by a primary care physician.
Earlier data reported at the American Psychological Association meeting last May found that 90% of patients on extended-release naltrexone had opioid-free urine screens over a six-month period, compared with 35% of those on a placebo injection. (See Monthly Shot Cuts Opioid Use)
The FDA said it relied on data from other studies, which found that 36% of patients stayed on treatment for six months, compared with 23% of placebo patients.
The agency said serious side effects include injection site reaction that requires surgical intervention and liver damage.
Other side effects could include depression, suicide, and suicidal thoughts and behaviors, although the treatment will not include any boxed warnings.
According to drugmaker Alkermes, about 10,000 patients a year currently use extended-release naltrexone to treat alcohol dependence, a treatment strategy approved in April 2006.
The drug has not had widespread uptake for that indication for a number of reasons, the company said. Many physicians are wary of treating patients with abuse disorders, and patients more often reach out for psychosocial counseling such as 12-step programs to beat their habits.
Researchers say these factors explain the slow uptake of many of the other pharmacological treatments for addiction.
Last month, an FDA advisory committee voted 12-1 to approve Vivitrol to treat opioid abuse.
By Kristina Fiore
Staff Writer, MedPage Today
October 13, 2010
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