Implantable Version of Suboxone for Opioid Addiction to Get FDA Review

Implantable Version of Suboxone for Opioid Addiction to Get FDA Review

The drug used for the treatment of opioid addiction – buprenorphine, commonly known as Suboxone – had been sold exclusively by Reckitt-Benckiser, a British pharmaceutical company, until its patent ran out in 2012. Since then, several pharmaceutical companies have rushed into the growing market to treat opioid addiction.

Braeburn Pharmaceuticals and Titan Pharmaceuticals (NASDAQ: TTNP) are joining the mix, as they jointly announced today that the Food and Drug Administration (FDA) Advisory Committee will review its new drug, Probuphine, on January 12, 2016.

Probuphine is an investigational implant that gives patients a steady dose of buprenorphine, an opioid addiction treatment drug, for up to 6 months via tiny rods about the size of a matchstick, which are implanted under the skin in the upper arm. It is intended to promote patient compliance as compared to oral formulations of buprenorphine sold under the brand name Suboxone.

“The data from the final phase 3 trial, which was designed in collaboration with the FDA in response to questions raised in the complete response letter, is compelling and we look forward to presenting it on January 12,” said Braeburn Pharmaceuticals President and CEO Behshad Sheldon. “More long-term treatments are needed to help people stay in recovery, and we remain excited about the potential for Probuphine to be the first of many new options for people with opioid addiction.”

Titan was told to conduct more research by the FDA in April 2013, when the agency surprisingly denied approval of the implant after FDA advisory committee had voted 10 to 4 a month earlier in favor of Probuphine. At that time, the FDA staff questioned the effectiveness of the implant and suggested the dose was too low, noting in clinical trials that about half of the patients treated with Probuphine required additional doses of Suboxone to treat their withdrawal symptoms.

The companies hope to enter the buprenorphine opioid addiction market, which racked up $1.75 billion in sales in the U.S. just last year.

“The Braeburn team has been interacting closely with the FDA, and we continue to support them as the Probuphine New Drug Application (NDA) advances,” said Titan Pharmaceuticals President Sunil Bhonsle. “We look forward to a successful meeting.”

You can find other National Pain Report articles related to buprenorphine here.

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Authored by: Staff

There are 12 comments for this article
  1. Rocky Hill MA, NCAC II, CADC II at 3:57 pm

    There is always a problem with “seeing these results day in and day out”, we are often blinded by our biases and greed. Since you are the largest provider of MAT, you must be providing methadone. Wouldn’t that hurt your bottom line to have a medication that meant that patients didn’t need to sell bupe to pay for their own prescription. Your “facts” just don’t jive with the reality of today’s epidemic of opiate dependence and the 29,000 people that died in 2015 (CDC records not conjecture). How do you know that only 50% of people really “want to work a program”? Did you ever take statistics of methods of social research in college, mark, because your statements indicate a lack of understanding that belies a manager of “clinics” in PA. I bet that the success of oral bupe and the coming probuphine is, likely, to cut deeply into that steady stream of patients coming to your facility? Guess that evidence based treatment was what President Obama had in mind when he called for the integration of abstinence and science in the addiction treatment field. Thank God for folks like he, Mike Boticelli and the Director of HHS, Sylvia Burwell. They will save thousands of lives. Mark, I would suggest that you find the study out of France from 1994, that indicated an 82% recovery rate with 108 heroin addicts. Yes, the study was well crafted and met all the standards for validity, credibility and accuracy that typify a competent study.

  2. Laurie Thompson at 9:21 am

    I have been on Suboxone for at least 5 years now. Coming off of 12 to 15 10 mg pain pills per day. Suboxone doses do not rise. I have been on 1 suboxone daily from the beginning and I dont care if I take 1 Suboxone daily for the rest of my life. I have never gotten high off of it, It does help my legit pain and to date, i have never heard of anyone overdosing on it. Common Sense, is it too much to ask for these days, and I pay for it out of pocket, along with paying 500 per month for medical ans prescription coverage, which does not and will not cover my Suboxone. Would tax payers wrather cover the many overdoses in this country? Yes, YOU are paying for that as well. Not all die from overdoses. Hospitals, EMTs, Doctors, ICU. Thankyou Taxpayers you just paid to save a life to throw back into the same world they just came out of. Soboxone is much cheaper. Check the average hospital bill of an overdose

  3. Caring mother at 9:56 pm

    I am sitting at my 22 year old sons bedside in the icu this Christmas Eve. He has escaped death by the grace of God. Finding my son slumped over in his bed choking on his own vomit is enough to scare anyone straight Except a heroin addict I understand and respect the nature of the addiction. Being a critical care trained nurse I see the affects of drugs on the body mind and spirit of all parties involved. I live on long island and am very interested in finding this implantable device. Any advice please. Caring MOTHER

  4. mike at 7:29 pm

    How long does it take for subs to be out of your sytem. Suboxzon is an evil drug

  5. Big Rob at 11:48 pm

    To be completely honest with y’all I’ve sold half of my script in the past, it was the only way I could afford them without doing illegal acts. I didn’t need to take all that they prescribed me.. I spent close to $800 to get put on them.. Script was over $400.. Because of suboxone and a 12step program I no longer shoot heroin or rob and steal nor do I have to sell drugs to to support a habit that I once had..

  6. Barb at 6:43 pm

    Are you Kidding Me??? Another way To keep addicts High. Whats going on Untied States? Other Countries Are Far Past us in A Cure. Not Keeping this Shit on The Market. Come on. Wow Now we Have Legal Dealers. How sad.

  7. Aaron at 8:23 pm

    I just want to say suboxone has saved my life and Mark I understand what you are saying but 50% of people that are on this medicine sell there pills . [edit] you don’t know that and why are you and others so against something that saves lives . If you want to say that just about bup . Well let’s take a wild guess how many people sell there pain pills , I would think a lot more because the doctors and the big pharmaceutical companies know what they are doing . They are the ones you should be talking about , they turn people into addicts with no thought at all . So maybe you you think about that too this medicine saves and changes lives . It’s a damn shame people have to hate on something that works .

  8. Wes at 7:52 pm

    Why would anyone want to take another variation of an opiate that actually attaches much tighter to the Mu receptor specifically.
    Sub is much harder to recover from than a traditional opiate. the long term healing process actually takes much longer. Verses just weaning down from and instant release formulation of Oxycodone. And quit Verses trying to quit Suboxone. is actually much harder
    But hey its Big Money for Big Pharm is not this the reality. If you on a time release like oxytocin . the switch to an instant release formulation wean down to a low level and then quit . Sure it’s a little uncomfortable. but nothing compared to tring to quit subs.

  9. Robert b at 5:33 pm

    Where can I sign up to try this I Wil let put it in for research

  10. Rocky Hill at 4:04 pm

    Gosh Mark, that leaves us little hope. We have used buprenorphine for ten years and found little problem with diversion as we continue to reduce the dose until we reach that point, just above PAWS. Can you give us some statistical facts, born of studies rather than just comments. As the largest provider of MAT, you sure don’t believe in your product. Why bother going on, is the money just too good? Isn’t that a good thing that they can’t and don’t want to get high since the receptor sites are closed.
    To the first person, buprenorphine has significant anti-cortisol properties and anti-inflammatory properties. I would check with you Doc, but we have never had problems with enhanced vulnerability to infections. Good luck and pray for Mark

  11. Emauney at 9:25 pm

    I am prone to infection due to endocarditis last year needing open heart surgery, I am currently on suboxone and am doing very well on it. I wonder if someone prone to infection would be able to try this, cause I would like too..

  12. Marc at 5:39 am

    This drug will never really get off the ground because after receiving the implant the user is unable to get high for at least 30 days. Unfortunately I would guess that at least 50% of all the $1.75B in Bup sales last year came from patients who are diverting their dose for cash ( $20-30/pill on street for 1 8mg pill which 90% of the time the taxpayers are paying for since its Medicaid ) Bup is the number one most diverted drug in the US currently and continues to rise each month. The only candidates for this implant are patients who are court ordered or the ones that really want to work a program and get clean. ( sadly this is only about half ) I own the largest state licensed MAT clinics in Western PA so I see these facts and figures first hand everyday