Category: Naltrexone Implant

  • Patients Discuss Their Naltrexone Implants

    Patients Discuss Their Naltrexone Implants

    The implant is currently not available in the United States.

    Six years ago, Peta Walker was ready to give up her fight against heroin and amphetamine addiction. She had tried medication-assisted treatment with methadone, but it had not worked for her.

    Desperate, she tried one more thing: a long-lasting stomach implant that releases naltrexone, a medication sold under the brand name Vivitrol that blocks the effects of opioids. 

    To Walker’s surprise and delight, it worked. “I’m doing things that I always dreamed of,” she told The New York Times

    Currently in the United States, naltrexone is available as a daily tablet or as a shot that lasts for a month. But the implant that Walker received from a doctor in Australia lasts for six months. 

    The doctor, George O’Neil, has been using the implants for nearly 20 years. The device isn’t approved in Australia, but he is able to give it to patients because the law allows people at risk of death to try unregulated medical treatments. The procedure costs about $4,800 U.S. dollars (about $7,000 Australian dollars). 

    For decades, O’Neil has been content to use his device on a relatively small scale, but now the implant is gaining international attention. “I’m good at dreaming, but there’s people around me good at doing,” O’Neil said. 

    When the Times reported the story, researchers from Columbia University in New York were watching O’Neil place an implant in a patient. The research team has been awarded nearly $7 million to study the possibility of a naltrexone implant, with an additional $14 million in funding available if the results are promising. 

    Dr. Adam Bisaga, a professor of psychiatry who is leading the study, said that a long-lasting implant is more appealing than a shot because it helps people commit to a longer stretch of sobriety. 

    “If we have a way of targeting the ambivalence—and the way you do that is long-acting preparation—that will be a major advance,” he said. “In the U.S., it’s pretty clear that it’s an acceptable and viable treatment.”

    Vivitrol, the injectable form of naltrexone, is already a popular medication in the United States because it lasts for a month and is not an opioid, unlike methadone and other medication-assisted treatment options. That makes it particularly appealing in law enforcement settings and jail, because it is impossible to divert Vivitrol for illegal use. The implant, if approved in the U.S., could broaden the appeal of naltrexone even more. 

    However, all forms of naltrexone do have some drawbacks. People who use naltrexone and then use opioids are at increased risk for overdose. In addition, to get started on the drugs people need to go through opioid withdrawal to first clear opioids from the system. 

    Despite that, the drug—and the implant—appeals to many people, including 25-year-old Jessica Martin, who received the implant recently. 

    “I feel better now coming here,” she said. “I feel confident that I’ll stop it.”

    View the original article at thefix.com

  • Louisiana Prisoners To Be Guinea Pigs For Unapproved Naltrexone Implant

    Louisiana Prisoners To Be Guinea Pigs For Unapproved Naltrexone Implant

    Participation in the program is strictly voluntary but advocates of prisoners’ rights say it sets a “dangerous precedent.”

    A pilot program is drawing controversy over the use of Louisiana prisoners to test a surgical implant for the treatment of alcohol or opioid use disorder.

    While some laud the idea of expanding access to medication-assisted treatment (MAT) for substance use disorder, others are critical of the pilot program since the device, which delivers naltrexone in the body, is not approved by the Food and Drug Administration (FDA).

    “There’s extra precaution to be taken when there’s a vulnerable population,” said Bruce Reilly, deputy director of the Voice of the Experienced, a New Orleans-based organization which advocates for prisoners’ rights. “It’s commendable that we’re pursuing treatments. We’re moving in a positive direction. [But] to sidestep or overstep the FDA approval process, that’s a little troublesome when it comes to an incarcerated environment.”

    Naltrexone, which blocks the effects and cravings of opioids and alcohol, is only approved in pill or injection form—the implant is not.

    Treating prisoners with the FDA-approved naltrexone has yielded success before in the Louisiana prison system. As The Advocate notes, of the 100 prisoners who were given naltrexone over a two-year period in conjunction with education and therapy prior to their release, only 4 have since landed back in prison.

    Encouraged by this success, corrections officials seem to want to take it a step further by approving the surgical implant pilot program.

    This time, the Louisiana Department of Public Safety and Corrections partnered up with BioCorRx, the maker of the implant. The California-based health care company has donated 10 of the devices to the state of Louisiana to implant in 10 inmates. Corrections officials stress that it is completely voluntary to participate in the pilot program.

    At $700 each, the naltrexone implant is cheaper than the monthly injection (about $1,000 each). The implant is said to metabolize in the body over 3-4 months, while the injection must be administered monthly and the pill is taken daily.

    It’s not hard to see why the implant may be more cost-effective than the pill or injection, but without FDA approval none of that matters, say advocates of prisoners’ rights.

    “If you’re really concerned about the population, why don’t you start with what’s approved? Consent is always problematic (in prison),” said Dr. Josiah “Jody” Rich, co-director of The Center for Prisoner Health and Human Rights.

    BioCorRx CEO Brady Granier said the implants have yielded positive results in more than 1,000 people. But Rich is not convinced.

    “We have a pretty bad history with experimentation in American prisons, I think the least we can do is use drugs that have been declared safe by our regulatory board,” said Rich.

    “Just because it’s free… I think it’s a really dangerous precedent,” he added. “We can’t afford to be stupid about this.”

    View the original article at thefix.com