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FDA Approves First Implant to Treat Opioid Addiction

The Probuphine implant. (Image: Braeburn Pharmaceuticals)
The Probuphine implant. (Image: Braeburn Pharmaceuticals)

The US Food and Drug Administration has approved Probuphine, the first implantable drug for the treatment of opioid dependence. It’s a welcome development at a time when scores of Americans are addicted to painkillers such as OxyContin and Vicodin.

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Prior to today’s announcement, Probuphine was only approved as a pill or as a film placed in the mouth until it dissolves. This hi-tech implantable version, which consists of four, one-inch-long rods that are placed under the skin, provides ongoing treatment for six months. Unlike pills or films, these implants can’t get lost, forgotten, or stolen, so the drug can’t be abused or resold on the street. What’s more, patients who are in recovery won’t have to be reminded or even think about taking the medication; the implants do all the work.

Image: Braeburn Pharmaceuticals
Image: Braeburn Pharmaceuticals
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“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,” said FDA Commissioner Robert M. Califf 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.”

Indeed, opioid addiction has become a serious problem in the United States. It’s estimated that 2.1 million people in the U.S. currently are addicted to prescription opioid pain relievers, while another 467,000 are addicted to heroin. The number of unintentional overdose deaths from prescription pain relievers has quadrupled since 1999. According to the CDC, deaths from opioid overdoses reached a record 28,647 in 2014. These drugs now kill more Americans than car accidents or guns.

Probuphine, which is marketed by Titan Pharmaceuticals and Braeburn Pharmaceuticals, is meant for people who are already stable on low doses of the drug. Administering the drug requires specific training, and only a health care provider who has completed the appropriate training is allowed to do it. At sufficient doses, the drug reduces opioid withdrawal symptoms and the desire to use, while also decreasing pleasurable effects of other opioids. Importantly, the implantable drug will be administered in conjunction with other therapies, including counseling and other behavioral therapies.

“Scientific evidence suggests that maintenance treatment with these medications in the context of behavioral treatment and recovery support are more effective in the treatment of opioid use disorder than short-term detoxification programs aimed at abstinence,” said Nora Volkow from the NIH. “This product will expand the treatment alternatives available to people suffering from an opioid use disorder.”

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The safety and efficacy of Probuphine was recently demonstrated in randomized clinical trial of adults. Over 60 percent of patients exhibited no evidence of illicit opioid use during the six months of treatment. That said, the implantable drug has its critics. As Judith Kramer of Duke University noted in the Washington Post, some trial participants still needed supplemental buprenorphine for relief, which to her suggested that the implant dose was too low. Other critics argue that it’s too expensive.

While these concerns are duly noted, something radical clearly needs to be done about this serious and ever-escalating problem. Kudos to the FDA for allowing this innovative product to hit the market, even it it’s still far from perfect.

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[FDA]

George is a senior staff reporter at Gizmodo.

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DISCUSSION

If the White House, other politicians, doctors, communities, etc... were sincere in tackling this problem (especially after addiction has taken root), and for the FDA to be deserving of some “kudos,” they would seriously consider looking into and treating heroin/opioid addiction medically with Ibogaine. Here’s a brief introduction (10 minute news report):

While the underlying issues as to what is driving this epidemic - both societal and personal - ultimately need to be identified and addressed, the demand for immediate treatment in the meantime is undeniable and an absolute necessity (especially if we are going to properly regard it as a disease instead of a moral failing). Given the expense, lack of clinical space/resources, and somewhat ineffectiveness of what one would consider the conventional approach - generally substituting heroin for equally as addictive methadone or Suboxone (both of which require chronic/perpetual usage) - or relying on the after-the-fact life-saving measures of naloxone (i.e. Narcan), it would seem that novel and effective approaches to treatment should be sought ought and embraced. And that’s what ibogaine seemingly offers, being derived from the root of a tree native to Africa. The only problem is, it’s classified as a Schedule I ‘psychedelic,’ and, as such, is banned from use and open study.

Here, too, is a somewhat recent article (2013) featuring another addict’s account detailing their experience with a small clinical trial that took place in Baja California, Mexico:

Mind-altering drug could offer life free of heroin (NewScientist)

Of the 29 others who took part in the trial, none are now reported as having problematic drug use. Two years after that one dose of ibogaine, I abstain from all drugs. Given the chance of relief from the physical and psychological dependence, I am free to make conscious choices again. We don’t yet know how effective this treatment would be in others, but the change in my life is startling.

I also recommend checking out the gut-wrenching documentary Detox or Die (produced by the BBC) about one filmmaker’s own journey with addiction (heroin to methadone), and - in a last ditch effort - his decision to give ibogaine a shot. Here is the point in the documentary when he gets treated:

And here it is in-full:

The filmmaker has been clean ever since (10+ years), and has actually dedicated his life to advocating for making ibogaine a viable treatment option.

Treatment centers are currently available in Mexico and Canada, but - while those who run the clinics go through great efforts to provide a safe and secure setting/atmosphere for their sessions and post-care - I’m not sure if they are all regulated. Which is all the more reason to raise awareness, to help encourage our own country to provide a safe, secure, and professional set and setting for those undergoing treatment. Mind you, this has been known since the ‘90s, with small clinical trials - along with those who have sought out personal treatment - demonstrating its efficacy (along with thousands of years of therapeutic and ceremonial use among indigenous African tribes). Check out the Multidisciplinary Association for Psychedelic Studies (MAPS) - a nonprofit specializing in advocating and providing funding for researching into psychedelic medicines - for more info:

Ibogaine Therapy for Drug Addiction

This isn’t to say it’s an easy peasy, one-and-done “magic bullet,” but - given its incredible results - it could be a game-changer. Might not benefit the bottom-line of drug dealers and drug makers/pharmaceutical companies, but - bottom-line - it will benefit people. Yes, a strong support system will likely remain necessary, and former addicts may very well have their good and bad days, but - as far as starting them off on the right foot and solid ground - ibogaine may be the best medicine available. And I encourage others, if they are unfamiliar with it, to look into it further, with hopes to raise awareness so this medicine can become decriminalized, given the study it deserves, and - hopefully - be openly available as a treatment option for those suffering from this terrible addiction. There have also been positive signs in treating heroin addiction using other “psychedelic” substances (like therapeutically administered ketamine...which has also proven useful in “treating” depression):

Ketamine psychotherapy for heroin addiction: immediate effects and two-year follow-up.

We will certainly need to look into other alternative/holistic pain management options (like cannabis, yoga, meditation, float tanks, acupuncture, electro-magnetic transcranial therapies, visualization techniques, cognitive behavioral therapy, support groups, etc…) to prevent/eliminate opiate prescription to begin with - or wean off in the early stages - as well. Not to mention get to work on the systemic changes society must likely undergo to address and remedy the over-prescription of pharmaceuticals, and even those underlying feelings of despair and destitution that also lead to opioid use/abuse in the first place. But, for those already under heroin’s long-term unrelenting grasp, this could be a great and powerful treatment option.

Here are more people whose debilitating and seemingly inescapable heroin/opiate addiction was treated successfully, under proper conditions, with ibogaine (these at a center located in Costa Rica). Four such testimonies (roughly 5 minutes apiece) follow:

Plenty more testimonials can be found at the YouTube page:

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