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FDA Approves New Opioid Addiction Treatment Combining Buprenorphine and Naloxone

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The Food and Drug Administration has approved a new drug to treat opioid addiction that combines buprenorphine and naloxone. The drug, Zubsolv, is similar to Subutex and Suboxone, according to Reuters.

Zubsolv is made by Swedish drugmaker Orexo. It dissolves under the tongue, and comes in a menthol flavor. “Zubsolv is indicated for use as maintenance treatment for people suffering from opioid dependence and should be used as part of a complete treatment plan to include counselling and psychosocial support,” the company said in a news release.

The company states that compared with current opioid drug treatments, patients will need to take less of the new drug in order to achieve the same effect, the article notes. Zubsolv is expected to be available in the United States in September, the company said.

In May, the FDA asked for more information on an implant designed to treat opioid addiction, before making a decision on whether to approve the drug.

The implant, Probuphine, is a long-acting version of the opioid dependence medication buprenorphine. It is implanted under the skin of the upper arm, in a procedure that takes about 10 to 15 minutes in a doctor’s office. It remains in place for about six months. The FDA asked for more information on the effect of higher doses of Probuphine, and on how doctors would be trained to insert and remove the implant.

20 Responses to this article

  1. angie / June 27, 2014 at 3:12 am

    I suffer from opiate addiction I want to live a clean happy life so bad but the withdrawal and detox kills m3 and my family please can someone help me with more info on these meds to help and how I can get it please

    • Kurt / August 2, 2014 at 2:28 pm

      Angie,

      I understand your pain. I have been taking up to 300mg of Oxycodone for 5 years now & i was sick of who i was becoming & I just wanted my old life back. You can either take Suboxone (Bupe & Naoxolone) or Subutex (Just Bupe) …Do yourself a favor and go to Suboxone.com & search for a certified Suboxone Doctor in your area. …Stick to the regiment & try your best to keep a positive attitude. Those that know of your struggle will be proud of you. Also, visit: http://www.wikihow.com/Endure-Acute-Withdrawal-from-Opiates-(Narcotics) This helped me a lot!!

      Good Luck & Keep Your Head Up!!

    • Steven Christopher Moore / August 12, 2014 at 2:31 pm

      Hey, keep your head up.. I hit rock bottom in 2009, I didn’t want to go on, one way or the other I was going to be free of that addiction..
      My story is simple: I Have an unusually severe, complicated case of Crohn’s disease, therefore I suffer chronic pain in my intestines,..and chronic pain in my Neck, Lower Back, and Hips, from years of Corti-steroid use for the Crohn’s inflammation. Prednisone destroyed my spinal structure. The pain at one time was unbearable, so I was put on ‘The Cycle of Death’, which is what Opiate based pain control is, in my opinion.. Inevitably I grew tolerant, was raised to higher doses, til 5mg Vicodins turned into Methadone wafers 40mgs, 80mg oxy’s, fentanyl durgesic pain patches, and dilaudid, aka K4′s.. I was GONE! Out my mind.. A very bad guy.., yet at one time had the kindest heart, and loved people, life, living, etc.. I wanted that ‘me’ back..

      So I made up my mind, simple as that.. I went into an ‘Oaks’ facility (I say ‘Oaks’, cuz it seems every detox/rehab center, most of them have an ‘Oaks’ in the name, Mine was River Oaks, near New Orleans, LA) ..I spent 5 weeks there, detoxing, and becoming accustomed to the Suboxone.. I will say this, Suboxone withdrawals are twenty times worse than any other withdrawal Ive ever experienced, which I felt when I ran out a few days early once.. So it’s not a cure-all.. What Suboxone does, is gets into your system, and then you finally have what’s called a “ceiling effect”, so you no longer get high.. You can actually function in life, hold a conversation with out DUCKIN OUT, looking like a jackass..

      I Suffer Chronic pain, which is as sure a trigger as anything else can be.. So I AM on a maintenance dose of Suboxone,..but my personal opinion, if You got that FIRE in your heart to quit right now, USE THE Suboxone to help with that, but after a YEAR, if you’ve noticed your Psyche, your general line of thinking has changed to that of what YOU feel is no-longer an addict, then ask to begin a Taper.. The LONGER you stay on Suboxone, the deeper it gets ahold of you too..

      My only fear is that with the direction this country is headed in under our current PoTUS’s command, there’s a chance life as we know it will be interrupted, and then if you can’t get ahold of your meds,..well you’re gonna be in a bad way..

      Good luck, and stick with it, I have FIVE YEARS clean this November coming.., and that’s with me having a Chronic pain condition.. So you can do it as well..

  2. denny / May 26, 2014 at 1:55 am

    Have bee on pain meds since 10 yrs old due to cluster headaches inheretied by my mother and have passed on to my daughter.I now have severe pain in my back and neck due to arthritis and injurys.I am a 56 yr old male.successful in life.
    Iam now taking 280 mg of Oxicotin twice a day and it pretty much takes care of the pain
    I wonder at times about maybe discontinuing thier use due to concerns of Ins. Companies continuing to pay the tremendous cost after Obama care has been around awhile and to being unable to go with out them.
    Other than cost why would I want to be on a lifetime regiem of detox and have still endure the constant pain that these meds have given my life back?
    Not wording this quite right but I hope u will understand my question
    Thank you and plz know ian very serious.
    Most Drs. Or Pharmacys Ive spoke to seem to have a bias towards one thing or another including automatically calling u a druggie

  3. Avatar of Ben Johnson
    Ben Johnson / March 24, 2014 at 10:33 pm

    Loperamide works good. It’s an opioid. Common in Immodium ad. You have to swallow at least 30 of the 2 mg pills to combat the dosage of oxycodone or pain pills you were taking. You can research the reviews from people who have tried it to get off addictive pain pills. The only down side is you have to ween off the loperamide because it basically prolongs the withdrawals.

    • Roberta / July 24, 2014 at 11:05 am

      Is that a med that needs to be prescribed by my dr or can I just go into a pharmacy and purchase it?

  4. Avatar of Steve
    Steve / October 21, 2013 at 1:21 am

    Ofcourse you need another “drug” to get off a drug. If you quit cold turkey on something you have been using for a long time your body will go into convulsions or all types and kinda of other things because your body was so used to having that substance in it and all of a sudden it’s gone so it does not know how to react without it. Not just opiates, alcohol and benzodiazepines as well and all other forms of medication, tapering down and switching depending on an individual’s case. Yes Ofcourse pharma makes money but isn’t that the American way? We all need money to live and thank god these pharmacies and doctors help some of us with the medicine they have or else the death rate on this country and many more would be severely high.

  5. Avatar of Blake
    Blake / September 17, 2013 at 5:22 pm

    Does anyone think it is strange that we have to use a drug….to get off another drug. Pharma has sold us all a bill of goods and made a killing off of us. Pathetic!!

  6. Avatar of tim-27 y.o. no dope since 09
    tim-27 y.o. no dope since 09 / September 4, 2013 at 2:32 am

    my name is tim and i am 27 years old and was a low bottom homeless dope and coke shooter from philly. i can read or hear pros and cons on all treatments. look at the rehab and jail % of relapse its a joke. ive been on suboxone for long-term cause without id get high. it helps in all facets i proved it over n over n over and the medicine works so sick of “dopers” like myself bitchin about taste or shooting the same drug that saved my life. if i ever had the balls to complain or do stupid shit like that id do dope damn drives me nuts. i take 1/8 of 8mg sub film 2 times a day with my fiance n went from somerset to our own place bills car jobs and 2 vacations a year ha. if thaat aint proof enough i used to shot puddle water cause 1 buck on a water was a waste to me sad sad times back in 09. fuck the haters ive changed 180 and had to go to jail for month and no terrible wdrawal. you call set apt wit dr and pay cash for the visit. make sure your insurance covers subs which should and please you dont fucking need 3 a day. take a half then wholesale what u dont need. its saved my like and allowedme to think clearly with no obsessions. my email is ttg215@yahoo.com if i can help at all. clean date november 3, 2009. 3-7 overdoses and im still breathing thank you god, please help me get out of my own way. my heart goes out to anyone with struggling kid did same to my family havent asked for 1 dollar from my mom in 4 years miracle also lol. “were only happy as we make our mind up to be” abe lincoln

  7. Avatar of KIM
    KIM / August 27, 2013 at 9:02 am

    I WANT MORE INFO PLEASE TELL ME WEBSITES OR WHAT EVER OTHER RESOURCES EVERYONE HAS USED. MY SON GETS OUT OF JAIL IN NOVEMBER, OF COURSE ALL
    DRUG RELATED HE HAS BEEN A USER FOR YEARS. I WOULD LOVE TO GET THINGS MOVING FOR WHEN HE GETS OUT . PLEASE HELP! THANK YOU

  8. Carlos / July 18, 2013 at 2:05 pm

    Implants could be a great procedure for those patients who may need residential services, but the treatment facilities are resisting the use of Suboxone or even Naltrexone for Alcoholics. While SAMHSA is pushing for this type of treatment within residential facilities, most of this facilities which are run by 12 Step Programs NONE EVIDENCE BASED facilities that believe that you shouldn’t treat drugs with other drugs. Of course they do not understand enough of the science to realize that this is a lot different than replacing one drug for another. A believe that is archaic and outdated.
    We need to start demanding that these 12 Step facilities become more adept at science. Something that they have being ignoring for too long and it is not in the best interest of US the patients, whose treatment is it anyway? This is a movement stated by National Alliance for Medication Assisted Recovery, a force of patients not to be recon with.

  9. Avatar of Kathy
    Kathy / July 10, 2013 at 9:33 pm

    Vivitrol in a non-narcotic, non-addictive, once a month treatment for opiate addiction that works. My daughter had a 7 year opiate addiction and will be clean two years this Saturday. Her first Vivitrol shot was exactly two years ago and she has not touched a drug since the first shot. Vivitrol is a once a month injection and it works. It worked for her when nothing else did.

  10. DrJJMD / July 9, 2013 at 8:59 pm

    Unfortunately, big Pharma has come after one of the MOST vunerable groups of persons yet again; those with opioid dependance! As an addiction psychiatrist, I’ve witnessed many patients, unable to fill their Rx for SL bup/ nlxn or even SL Bup. The US passed the,”Drug Addiction Treatment Act of 2000 (DATA 2000),” which granted authority to the Secretary of Health & Human Services to provide waivers to physicians with certain training to prescribe and administer Schedule III, IV, or V narcotic drugs for the treatment of addiction or detoxification. Prior to the passage of this law, such treatment was only available in traditional Opioid Treatment Program (OTP/NTP)
    The first buprenorphine treatment program for opiate addiction in the United States was founded by McDowell et. al at Columbia University & reported a success rate = 90%. Despite years of research to the contrary, methadone remains a gold standard in the armamentarium of physicians. However, the passage of DATA in 2000, did NOT include Schedule II medications such as methadone, which even in 2013 remains one of the MOST regulated Rx drugs in the USA. Me and my colleagues hoped that this law would motivate many to develope a greater number of medications that could be Rx out of our offices AND that part of the law would restrict the amount that can be charged per Rx! In Austria & other European countries, the opioid treatment community has developed relatively safe & tamper resistant morphine product that are to be taken daily. In addition, Ive personally attempted to make it legal to Rx a medication (used in Germany) called Levo-Methadone, the pharmacollogically active component of the methadone patients in the USA, receive daily in the Federal NTP/OTP framework. Theoretically it would allow dosages to be halfed and potentially reduce the chances of a patients developing QT prolongation; including Torsades de Pointes. The British company, Reckitt, in 1979, first launched buprenorphine in the UK as an injection to treat severe pain, with a sublingual formulation released in 1982.
    Buprenorphine sublingual preparations were and continue to be used in the management of opioid dependence. The Suboxone and Subutex preparations were approved for this indication by the United States Food and Drug Administration in October 2002. The same year, the DEA re-scheduled buprenorphine and buprenorphine-containing products from Schedule V to Schedule III of the Controlled Substances Act. This had been the first change in US law regarding opioid dependance since Dole and Nyswander pioneered methadone replacement treatment for .
    The track record of opiate replacement therapy, while not perfect, has permitted hundreds of thousands of Americans (and millions more world wide) to achieve a reduction in the number and severity of relapses to illicit opiate use and associated costs to society in terms of criminal activity (burglary, theft, robbery, muggings) necessary to obtain money for drugs which ultimately wind up financing the vast, globally connected drug cartels. Additionally, opioid replacement therapy reduces the risk of contracting Hepatitis C and HIV among other communicable diseases. This, along with lowered rates of recidivism and incarceration for drug-Prohibition related crimes as formerly active addicts reorient their lives from the daily quest to stave off opiate withdrawal and reintegrate into society as law-abiding citizens, has not changed the fact that the appearance of methadone clinics across the United States has changed little since their inception in the early 1970s. Opiate replacement therapy remains strictly regulated despite its success in harm reduction for both patients and society.
    In the United States, a special federal waiver (which can be granted after the completion of an eight-hour course) is required in order to treat outpatients for opioid addiction with Subutex and Suboxone, the two forms of buprenorphine tablets currently available. However, the number of patients each approved doctor could initially treat was capped at ten. In no other area are physicians prevented from providing care to patients in need—except for addiction treatment. The history of the War on Drugs adverse effect on doctors began shortly after the passage of the Harrison Narcotics Tax Act in 1918. Since that time, doctors attempting to treat opiate addiction have faced disciplinary actions ranging from warnings and fines through suspension or permanent loss of their DEA License number (required by the Controlled Substances Act for a doctor to prescribe drugs “with abuse potential”); loss of their medical license to practice, and jail time. The stigma of opiate addiction has always tainted those physicians seeking to treat addiction, reflected in the low status of “Addiction Medicine” among medical students choosing a specialty.
    Due to the response of patients seeking a treatment alternative to methadone clinics, the law was modified to allow properly trained and licensed doctors to treat up to a hundred patients with buprenorphine for opioid addiction in an outpatient setting, alleviating the bottleneck that was created with the ten-patient limit (see next paragraph). Other obstacles to treatment still remain however.
    On December 12, 2006, the U.S. Congress passed additional legislation that relaxed the patient restriction for doctors who specialize in treating addiction through group therapy, allowing doctors with at least one year of clinical experience with buprenorphine to request an additional exemption within DATA 2000, which increases the limit to a hundred outpatients, effective as of 12/29/2006.
    Similar restrictions are placed on prescribers in many other jurisdictions/nations. For example, buprenorphine liquid is regulated in the same way as methadone in Australia, and while the number of patients per doctor isn’t capped, the patient is required to visit a pharmacy daily in order to receive a supervised dose of their medication. Buprenorphine transdermal patches are regulated as a controlled substance, with GPs requiring approval for all prescriptions and a limited number of repeats available. The withdrawal from buprenorphine after short-term use generally is far milder than other potent opioids but can have a longer duration than short-acting opioids of abuse. Opioids with shorter half-lives tend to have shorter initial withdrawal periods, while those with longer half-lives add length to the total withdrawal period.

  11. jboside / July 8, 2013 at 4:34 pm

    The skin drug could be a big plus if they could reduce the milligrams over time to where after 6 months the person could kick the drug at a low level.

  12. Avatar of Andrea
    Andrea / July 12, 2013 at 1:23 pm

    Kathy…That is so wonderful & the best & positive news I heard about recovery in a very long time!!! I wanted that for my son but wasn’t sure about it since it was fairly a new treatment alternative. I’m so glad I read your post. My son is actually coming out of a Detox facility tomorrow and I’m so stressed out. I was wondering if he can get this shot. My family & I have been struggling with his addition for 4 years & nothing seemed to work. It’s a very painful & debilitating experience. Best of luck to you, your daughter & family.

  13. Carlos / July 18, 2013 at 3:04 pm

    Good luck madam, I know what is like. You would think that drug laws would have been about the well-being of the community and the health of the users. But history has shown opposite, in the long run the way that the US government has deal with drug laws it has worsen the conditions for both the addicted person and the community. I can think of one thing like drive by shooting and the drug wars in Mexico that are not the direct result of the way we have done the drug laws and the harm creating and punitive measures usually used by the government. It has even be part of many public funded facilities to be punitive and harm producing rather than empathetic and therapeutic like they were taught in college. Is like most of these treatment staff has rapidly forgotten the science and approached they learned in college and now without evidence have created a treatment approach that does not work, no matter how much public relations they try to push down our throats. Like I said before I have been bamboozled by treatment staff for too long. It is now time to turn my rage in to action. I hope that families and patients join the movement for more humane treatment and civil right discrimination against persons like us that will do well with appropriate treatment. And not took keep our history like a sword over our head waiting for someone to cut it off. NO matter what they think about us, we are not all liars and manipulators like treatment staff and twelve steps member believe about themselves. That is stereotyping and stigmatizing all of us. And even if some of us might have been like that, when we get treatment the conditions are no longer the same. We are no saints, but so is the rest of the human populations are not either.

    National Alliance for Medication Assisted Recovery

    I take my hat off to buprenorphine and question the high cost place by the pharmaceutical companies.

  14. Avatar of Gene
    Gene / September 11, 2013 at 8:04 pm

    Kathy that is great news bringing great hope! My son was in active opioid use for 4 years. He had “the shot” and remained clean for the 8 months he was receiving it. After 3 months off the shot, he returned to using but has now detoxed and had the shot today. We remain hopeful as a family, but the pain is with us when he’s not following the program. U of P in Philadelphia has a terrific program for opiate addiction.

  15. Avatar of Seth
    Seth / March 11, 2014 at 2:43 am

    Hey my name is Seth Byrd and I lost my little girl that died 6 mo ago and I live in tennessee and if you can help me find a dr that will help with the paying for the pill this it would mean the would to me.

    Thanks
    Seth Byrd. 423-388-4337

  16. Avatar of addiction psych
    addiction psych / October 6, 2013 at 5:20 pm

    I’ve been treating opiate addiction for over 5 years and routinely prescribe buprenorphine SL film (Beckitt has discontinued the tablet version which I personally preferred… however Subutex is still available as a generic). As a medical provider, I just want to agree with what the other MD posted it’s very accurate. I have found buprenorphine to be vastly superior to oral methadone in terms of long term recovery. The awful withdrawal effects are often too much for patients to handle with methadone. Consequently, many cannot stay clean after discontinuing “ORT” or opiate replacement therapy; the lure of opiate abuse is often too much to overcome and relapse. As many other posters have mentioned, Vivitrol, or naltrexone is a long acting opiate antagonist (this means it blocks opiate drugs from having an effect on the CNS which discourages abuse). My professional opinion is that successful recovery requires a personally tailored treatment plan in terms of BOTH medication and psychotherapy. Patients also sometimes require long term maintenance… years of treatment… and medication is often required as prophylaxis, indefinitely.

  17. Avatar of Colleen
    Colleen / February 24, 2014 at 8:48 am

    The idea of having the dose come down over the period of six months, is brilliant.

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