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new form of a widely used opioid addiction treatment that is injected monthly instead of taken daily as a tablet was approved Thursday by the Food and Drug Administration. Experts say the eagerly anticipated new version of the drug may help patients reduce relapses, disrupt the treatment market, and possibly dispel misconceptions about the drug’s potential for abuse.

Indivior is the first company to gain approval for a monthly injection of buprenorphine. The company is best known for Suboxone, a daily formulation that combines buprenorphine with naloxone into a film that dissolves under the tongue.

“It’s potentially a game changer,” said Dr. Andrew Kolodny, co-director of opioid policy research at Brandeis University. “This could become first-line [medication] for opioid addiction. It could open up opportunities for getting more patients on buprenorphine.”

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The new product, known as Sublocade, was one of two long-acting buprenorphine injectable products before the FDA. Approval for Indivior’s drug was anticipated after an advisory panel voted 18 to 1 to recommend it in October. A decision on a similar medication made by Braeburn Pharmaceuticals is expected early next year.

FDA Commissioner Scott Gottlieb said that Sublocade was “part of our ongoing work in supporting the treatment of those suffering from addiction to opioids.” The approval of the long-acting buprenorphine was in line with the FDA’s plans to “issue guidance to expedite the development of new addiction treatment options,” he said a statement.

“We’ll continue to pursue efforts to promote more widespread use of existing, safe and effective FDA-approved therapies to treat addiction,” Gottlieb added.

The FDA noted that Sublocade’s approval followed two clinical studies — including a randomized controlled clinical trial and an open-label clinical trial — of 848 adults who had been diagnosed with moderate-to-severe opioid-use disorder and had started taking Suboxone first. The results of the studies found that patients who were treated with Sublocade had “more weeks without positive urine tests or self-reports of opioid use” than those who administered a placebo.

The findings also showed that a higher proportion of patients on Sublocade had “no evidence of illicit opioid use throughout the treatment period,” the FDA said in a statement. The agency noted the most common side effects of Sublocade included constipation, nausea, and vomiting.

Patients who get Sublocade will receive an abdominal injection administered by a health professional after starting a daily regimen of sublingual buprenorphine tablets for at least seven days. If approved, Braeburn’s long-acting product, CAM 2038, would be available as either a weekly or a monthly shot, and would not require these stabilizing doses of daily buprenorphine. 

Both long-acting products differ from Alkermes’s Vivitrol, the leading brand of injectable extended-release naltrexone, because neither one requires a detox period before patients can receive their first injection.

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Providing more options for patients to take buprenorphine, Kolodny said, will make them better positioned to benefit from the drug and more likely to feel “well and normal” compared to naltrexone.

“Buprenorphine gives a stimulation of the opioid receptors, and that means better control of cravings without experiencing subclinical withdrawal,” he said.

As the nation’s opioid crisis worsens — an estimated 50,000 people died of opioid overdoses in 2016 — spending on medicine to treat opioid-use disorder has skyrocketed, with Medicaid-covered prescriptions more than doubling between 2011 and 2016.

In terms of market share for those drugs, Medicaid spending last year on buprenorphine prescriptions was five times higher than naltrexone, the only monthly injectable available to patients seeking treatment for opioid use disorder. The approval of long-acting buprenorphine could diminish one of the biggest competitive advantages held by Vivitrol, which was approved in 2010 to treat opioid use disorder.

While a major study found that both treatments had comparable effectiveness, it also concluded that patients had a harder time getting started on Vivitrol because they needed to be fully detoxed first. Some experts believe long-acting buprenorphine could dramatically influence addiction treatment across the country.

“This new technology has the potential to greatly influence the way patients are treated today,” Mike Derkacz, CEO and president of Braeburn, told STAT. “[It can] free patients from the daily decision and reminder of the disease.”

Long-acting buprenorphine could also make further inroads within the criminal justice system. In recent years judges, wardens, and health officials have warmed up to Vivitrol, citing fears that daily tablets of buprenorphine can be diverted or abused.

The risk of abuse has prompted physicians and officials — including former U.S. Health Secretary Tom Price — to downplay its effectiveness by saying buprenorphine “substitutes” one opioid for another.

“In the criminal justice setting, they’ve been very reluctant to provide [daily doses of] buprenorphine in prisons,” Dr. Nora Volkow, director of the National Institute of Drug Abuse, said in a recent STAT interview. “The question now is how will they respond to [the fact that] extended-release buprenorphine cannot be diverted.”

Dr. Chinazo Cunningham, associate chief of general internal medicine at Montefiore Medical Center, says she’s “skeptical” that this particular formulation “is going to be the answer” to widening the use of buprenorphine. She said that providers need more training to overcome the current lack of education in treating opioid use disorder.

“There’s still a tremendous amount of stigma among patients and in communities about taking any opioid agonist in treatment,” Cunningham said. “I hope that a reduction in potential diversion [from long-acting buprenorphine] may get more providers to offer buprenorphine [of all kinds]. The more options the better, so we can match treatment to patients’ needs.”

Derkacz of Braeburn told STAT that the company expects a decision from the FDA on its long-acting CAM 2038 by January 19, 2018.

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  • It’s good to hear that some people want to eliminate their opiate addiction. This surprises me. Good luck and best wishes to each of you.

    • Really? Why wouldn’t people want to treat their addiction? It’s a medical disease just like any other…

  • Yes, I am excited, I am a 40 years addicted opiate abuser. I have been on Suboxone on and off for 9 years. What I would give for a once a month injection, I am in tears to think I might just beat this. Thanks for all you do.

  • I too live in Cuyahoga county. Cleveland Ohio. One of the highest county’s in the U.S.A for overdose deaths. I have the same interests in exactly how much this new saviour is going to cost. To drug addicts 20 dollars can make them not sick and able to function for the fight for the next 20 dollars. Every addict that I have asked does not spend over 40 dollars a day. So 40 multiplied by 30 is $1200.00 give or take. Most addicts pan handle,steal,or prostitute. So that $40.00 is never garunteed. Vivitrol costs upwords of $1000.00. And is not paid for by Medicare/Medicaid. Most people who do take it had to go to jail and have an ongoing case pending so that a judge could order said person to receive the injection. It is a catch 22 not only is the person to receive the injection but also have to follow a case plan that is usually sat up for the addict to fail. So once the defendant eventually messes up their usually sent back to jail and when this happens they are usually sent to C.B.C.F or prison. So no need to be placed back on the injection. Then the cycle starts with the next defendant and so on. When will we begin to understand that people in inner citys usually are not from BEVERLY HILLS 90210 and barley have enough food in the fridge to make it to the next month. Why do the DRUG COMPANY’S take a drug that probably cost them $100.00 to make and disribute inflate the price to well into the thousands. Some thing that could help so many people but the truth is most people/addicts will never get the chance to find out if this is the one thing that could’ve restored them to sanity. All because of greed. Where their is nessesity their will always be a way to tell the one who is truly in need of help it will come tomorrow. You and I know tomorrow never truly comes does It? Tomorrow is always today’s yesterday. The reason I know this so we’ll …I too am an addict for over 5 years I have begged and pleaded for help… When your an addict your never truly heard…..Can anyone HEAR me now!

  • My name is Aileen and I’m an addict. I live in Cleveland ohio. I have been an opioid user for over six years. I have tried detox ,neloxzone, treatment, and jail. Nothing seems to work. I have seen girls in jail take the vivitrol shot and as soon as they get out use. So one it did NOT help cravings and two they still could get high so eventually they would not go back and take the next month’s shot. I have been praying for something to come along that I don’t have to pay for a ride to get to everyday and that I won’t have to go threw the most “severe” withdrawal symptoms either. I am very serious about getting and staying clean .I am on State Medicare medicade will the pay for this “treatment”? How can I afford this? I barley scrape by trying to keep my self off sik. I believe with all my being that this new injection is going to be the leader in getting a handle on this opioid epidemic. In any event that Indivior could use someone that is serious about recovery knows the true meaning of “needing” to get well and becoming a productive part of helping others find “their” cure. Count me in I have never been more ready or serious in my life. I guess what I am truly asking for is help! I know that I DON’T have six more years to give to this disease. Please some one if you truly want to help…Im here pleading not only my case but the case’s of the other addict that suffers due to inability to pay for help that’s millions of dollars away from our grasp. I thank you in advance for taking time out of your day to hear the honest plea of someone who is serious about getting off opioids and taking back their life.

    • Hello Aileen,

      I have lost 2 family members to opioid addiction. Please hang in there!

      Please have a look at the BioCorRx program. The program combines a proprietary compounded naltrexone implant with a structured, proprietary counseling program specifically tailored for the treatment of alcoholism and opioid use disorder.

      The implants last much longer than the pills or injections and victims cannot skip a pill or a shot.

      People claim the cravings are gone which allows for the counseling to take hold. You need a clear head to implement the right strategy.

      This is relatively new but the results seem to indicate success. The kid from Growing Pains credits this for saving his life. Here are some video appearances to help get you acquainted:

      https://www.biocorrx.com/news-media/media

      They are 3 locations in Ohio. Not sure where but here is a press release.

      https://www.biocorrx.com/news-media/press-releases/detail/89/biocorrx-announces-enlitetm-clinics-to-implement-the

      Please don’t give up. Best of luck and God bless you!

      -Ed

  • Very exciting. Particularly as does not require total detoxifying before it can be used. Is there evidence extended release any better than what is out there now – do people do better? How much better? I am curious about the price tag – what does it cost on top of BUP-NX’s current cost to get the new extended version. How many billions does big pharma have parked off-shore currently? 290 billion? Re comment below – MAT using methadone or BUP-NX are both effective for many, many people. Naltrexone alone doesn’t work for everyone. Treatment should be based on what is best for each individual patient – should have access to alternatives.

  • After reading comments from some readers who have been taking opioids for many years, I’m skeptical that many addicts want to change, but this might help some people. It seems to make more sense to stop putting patients on opioids on a long-term basis unless they have cancer, a terminal condition, or something that is truly extraordinary. Unfortunately it is often profitable to put others on opioids on a long-term basis, which creates a financial incentive to do so.

  • They are not addressing the biggest issue that withdrawals from Suboxone are worse than words world’s from heroin the benefit of Vivitrol is that it is non-narcotic and therefore does not cause withdrawal symptoms when you come off of it the extended use format is just a bonus why would I want to kick dope just to kick Suboxone sometime down the road just like every other disease and there’s no money in The Cure so might as well get them hooked on something else

  • Please notify when the buprenorphine injection is released, my son is struggling to stay sober to receive the vivotrol injection. Or if he get the injection now through a program. I would appreciate you informing me ASAP. Thank you.

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