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THURSDAY, May 26, 2016 (HealthDay News) -- A new long-acting implant that can help treat people addicted to heroin and prescription painkillers was approved Thursday by the U.S. Food and Drug Administration.
"Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives," FDA Commissioner Dr. Robert M. Califf said in a statement. "Today's approval provides the first-ever implantable option to support patients' efforts to maintain treatment as part of their overall recovery program."
Probuphine is placed in the upper arm of recovering addicts and releases a steady six-month dose of buprenorphine, an anti-addiction drug designed to combat the cravings that come with opioids like heroin or powerful prescription painkillers like Percocet or OxyContin. Buprenorphine is already available as a pill or a film that can be placed in the mouth.
The steady flow from the implant will reduce fluctuations that can occur when taking a medication once or twice daily, and it removes the need for a patient to remember to take it, said Dr. Annie Umbricht, an expert in substance abuse treatment at Johns Hopkins University in Baltimore.
"A person suffering from addiction would not have to go through the up-and-downs of a daily medication, and therefore will feel much more normal," Umbricht explained.
Clinical trials published in the Journal of the American Medical Association in 2010 showed the implant led to higher abstinence rates among addicts, with 40 percent remaining drug-free compared with 28 percent receiving a placebo.
People given the implant also were more likely to remain in treatment, about 66 percent compared with 31 percent of the placebo group.
"It really reduces or eliminates cravings, and they don't start searching around for opiates," said Dr. Scott Segal, president and chief medical officer of the Segal Institute for Clinical Research in Miami, one of the centers that participated in the clinical trials.
The implant provides patients with no-fail treatment during its six-month period of effectiveness, Segal said.
"Things happen in life," he said. "You miss your doctor's appointment, the pharmacy doesn't have the medication and there's problems. The implant takes relapse off the table."
It takes about 15 minutes to place the implant, Segal said, and side effects are similar to oral buprenorphine. They include headache, depression, constipation, nausea, vomiting and back pain, according to the FDA.
"I was concerned that patients would [not] like this option, and I was dead wrong," he said. "The patients enrolled quickly. They liked it. They tolerated it well. And they were upset when we took them off the implant at the end of the study."
The United States is experiencing an epidemic of prescription drug abuse, and the new implant could also help counter that, Umbricht said.
There were 28,647 overdose deaths related to heroin and prescription pain killers in 2014, an average of 78 per day, according to the U.S. Centers for Disease Control and Prevention.
That's because people undergo treatment and lose their tolerance for opioids, but then leave treatment with a high risk of relapse, Umbricht said.
"We know the rate of relapse after drug treatment is more than 90 percent," Umbricht said. "These people have lost their tolerance, but they don't realize it. They are at high risk for overdose."
The implant can help stabilize addicts during treatment, and then provide them with support against relapse once they've been released, she said.
Buprenorphine provides effects that are similar to, but weaker than, opioids like heroin or methadone, according to the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA).
But those effects level off at moderate doses, lowering the risk of misuse and addiction, SAMHSA says.
Buprenorphine also interferes with the effects of full-strength opiates, Segal said.
"It tends to saturate the receptors that respond to opiates," he said. "Even if you were to take opiates with it, you won't get high. It provides pain relief, but doesn't give them the buzz or high that heroin would."
The implant eliminates one other concern associated with oral buprenorphine -- the likelihood that someone with a prescription will share their pills with friends.
Researchers estimate that as much as 50 percent of oral buprenorphine prescriptions are "diverted," Umbricht said.
The intent is most likely to help other people quit their drug habit, Umbricht said, but without drug counseling those addicts are not likely to succeed.
"That person is not going to get the psychosocial support they need," Umbricht said, adding that drug sharing also maintains illegal behaviors that recovering addicts need to shake.
Addiction specialist Dr. Kevin Cotterell agreed.
"The prospect of a long-acting opiate agonist-antagonist surgically implanted for use in the treatment of addiction to opiates is very encouraging," said Cotterell, a psychiatrist with South Oaks Hospital in Amityville, N.Y. "It will help in overcoming problems with compliance, which is a great barrier to recovery. It will enhance safety and reduce diversion if used widely."
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SOURCES: Annie Umbricht, M.D., an assistant professor and expert in substance abuse treatment with Johns Hopkins; Dr. Scott Segal, MD, MBA, president and chief medical officer of the Segal Institute for Clinical Research in Miami; Dr. Kevin Cotterell, MD, a psychiatrist with South Oaks Hospital in Amityville, N.Y.; Jade Trombetta, spokeswoman for Braeburn Pharmaceuticals