Posted on 05/28/2016 1:21:28 AM PDT by nickcarraway
Labels for the first long-acting opioid addiction treatment device are rolling off printing machines Friday. Trainings begin Saturday for doctors who want to learn to insert four matchstick-size rods under the skin. They contain the drug buprenorphine, which staves off opioid cravings.
The implant, called Probuphine, was approved by the Food and Drug Administration on Thursday, and is expected to be available to patients by the end of June.
"This is just the starting point for us to continue to fight for the cause of patients with opioid addiction," said Behshad Sheldon, CEO of Braeburn Pharmaceuticals, which manufactures Probuphine.
But debate continues about how effective the implant will be and whether insurers will cover it.
Nora Volkow, head of the National Institute on Drug Abuse, calls Probuphine a game changer, saying it will help addiction patients stay on their meds while their brain circuits recover from the ravages of drug use.
And addiction experts say it will be much harder for patients prescribed the implant to sell their medication on the street, which can be a problem with addiction patients prescribed pills.
"I think it's fantastic news," said Dr. Sarah Wakeman, medical director of the Substance Use Disorder Initiative at Massachusetts General Hospital. "We need as many tools in the toolbox as possible to deal with the opioid epidemic."
Still, Wakeman is concerned that the implant only delivers one dose of 8mg of buprenorphine daily. She prescribes between 4 and 24mg, depending on how much a patient needs to fight opioid cravings.
"This is wonderful tool for someone who doesn't want to take a daily medication" or someone who can't manage doing so, Wakeman said. "If you need to add daily medication on top of Probuphine, you lose the added benefit that would come without needing that daily pill."
Sheldon says Braeburn is testing weekly and monthly injections of buprenorphine that would be available in many doses.
Wakeman plans to sign up for a four-hour Probuphine training session, which includes a lecture, a demonstration and practice inserting the implant. The company does not know yet if it will be safe to insert implants repeatedly into the same spot in the upper arm. A study is underway.
In the meantime, some doctors say they will hold off on using the implant. Dr. Indra Cidami, who treats addiction patients in New Jersey, says she's worried patients will assume it's enough, that they don't need the check-ups or the counseling that are part of most recovery programs.
"Probuphine is set up for failure in that way," said Cidami, "because the patient will be seen after six months and in the meantime, they're not going to be following up with therapy. And that means it's not going to be medication assisted therapy — it is medication maintenance only."
Braeburn Pharmaceuticals and the FDA say they expect patients to be in counseling while prescribed the implant.
In Massachusetts, the state's largest health insurer says it will cover the device, which will cost $4,950, or about $825 a month. But some other insurers say they aren't sure yet if the implant is worth the price compared to pills, which cost $130 to $190 a month.
Braeburn CEO Sheldon says that Probuphine will be cheaper than Vivitrol, a form of naltrexone that is injected once a month and costs about $1,000 a month.
"Certainly the drug holds great promise for individuals struggling with opioid addiction. However, there's still a lot we don't know about its effectiveness," said Eric Linzer, senior vice president for the Massachusetts Association of Health plans.
Braeburn says it may refund money to insurers if the Probuphine implant doesn't work to keep patients from relapsing and offer rebates for patients who have to buy it on their own.
So non-users will be paying for users?
If it helps break the addiction, I for one am all for it. We pay more for incarceration charges for crimes they commit to support their expensive habits.
So the FDA doesn't care about the effectiveness of Drugs they approve, whats up with that?
The WALL will be built and all trade from Afghanistan has been stopped
This sudden so-called opioid epidemic was created/allowed by the government.
They’re trying to pin it on the doctors by using the lame excuse of over-prescribing pain-relieving meds to an aging population.
Once President Trump builds us our wall and we start burning the poppy fields in Afghanistan you will see this “epidemic” disappear from the daily headlines.
It’s time for a real War On Drugs.
Vote Trump.
That sounds like no fun at all. /S
Does it work with opiates, too?
Opiates are natural drugs derived from opium. They include opium, codeine, morphine and heroin.
Opioids are SYNTHETIC drugs that mimic opiates.
Narcotics include both opiates and opioids.
The press however, is bent on calling everything an opioid.
The FDA cares a lot. Once a drug is approved, the FDA does not stop monitoring its safety and efficacy. The pharmaceutical companies are required to continue to work with the FDA in what is called a "phase 4 clinical trial," which is where the company still collects data on patients who are using the approved drug by prescription.
If the company wants to market the drug for a slightly different purpose than it was approved for, the company has to do clinical trials in support of the altered use. For example, the approved implant delivers 8 mg of the drug per day. But if the company wants to market an implant with a different dose, they have to test at that dose before the FDA approves it.
Drug testing and approval is a very complicated business, involving scientists, physicians, lawyers, and reams of paperwork.
Since it only good at treating addictions, what good is it to those who live in chronic pain? And there are millions of us that do. The medical profession has brainwashed doctors that older drugs are useless. Well your new drugs are so side effect riddled that it amounts to a drug reaction and you can’t take it.
Stupid PCP wants to take my two 10 mg Valium (generic) away, that lowers my Fibromyalgia pain in half, and replace it with Lyrica...I’ve tried twice...375 MG and keep raising the addictive crap, the side effects are worse than the FMS. Causes extreme pain in lumbar, hands, feet, and that sends my BP into heart attack zone. That was 1 pill. Went into the trash can real fast, took 3 days to get the 1 pill out of my system. Keep your crap that is worse than the older no side effect Valium.
Where is the NON ADDICTIVE pain meds? And I’m not talking Tylenol or the other OTC crap that eats your stomach up.
It is not all about incarceration, it is about why is there a whole wave of drug abuse that has come back from the drug problem we had in the past! There is no accountability with those that are addicted. Also, most of them should be off the dole, instead the Government keeps on feeding the beast.
I had a friend that got addicted to morphine from a severely broken leg sustained in a sledding accident that had him hospitalized for 6 months. He became addicted at the age of sixteen from the excessive morphine administered to him in the hospital. We do not live in a perfect world, but anything that might help to cure addicts, I am all for.
You are just a hater
Oh no! Did you get stuned?
buprenorphine ................ This was the drug that was found in the backpack of the Dr.’s son who arrived the day of Prince’s death to try and get him back to California for treatment. Guess this is what was going to be given to him to try and convince him to get treatment.
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