1. Dear Drugs-Forum readers: We are a small non-profit that runs one of the most read drug information & addiction help websites in the world. We serve over 4 million readers per month, and have costs like all popular websites: servers, hosting, licenses and software. To protect our independence we do not run ads. We take no government funds. We run on donations which average $25. If everyone reading this would donate $5 then this fund raiser would be done in an hour. If Drugs-Forum is useful to you, take one minute to keep it online another year by donating whatever you can today. Donations are currently not sufficient to pay our bills and keep the site up. Your help is most welcome. Thank you.
    PLEASE HELP

Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA priori

By Basoodler, Jan 4, 2013 | Updated: Jan 4, 2013 | | |
Rating:
4.5/5,
  1. Basoodler
    Titan Pharmaceuticals, Inc. (OTCBB:TTNP) have announced that the New Drug Application (NDA) for Probuphine® has been accepted for review and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). Probuphine is a novel, subdermal implant and the first long-acting product designed to deliver six months of the drug buprenorphine hydrochloride following a single treatment. Titan submitted the NDA for the maintenance treatment of opioid dependence in adult patients in October 2012 under Section 505(b)(2) of the Food, Drug and Cosmetic Act and referenced the approved sublingual tablet formulations of buprenorphine.

    Priority designation is given to therapies that offer potential major advances in treatment, including improved safety, or provide a treatment where no adequate therapy exists. Based upon the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of April 30, 2013 for FDA action on the NDA.

    "This is an important milestone for Probuphine and the Priority Review designation further underscores the critical need for new treatments for opioid dependence," said Katherine Beebe, Ph.D., executive vice president and chief development officer at Titan. "With more than two million people addicted to opioids in the U.S. alone, there is a need for safe and effective treatments that also reduce the risk of abuse or accidental use. Probuphine has demonstrated clinically meaningful and statistically significant treatment benefits across several clinical trials and we look forward to supporting the NDA review process and, potentially, offering a new treatment option to patients and physicians."

    Last month, Titan announced the signing of a license agreement with Braeburn Pharmaceuticals Sprl, wholly owned by Apple Tree Partners IV, L.P., a partnership affiliated with Apple Tree Partners. The license grants Braeburn exclusive commercialization rights in the United States and Canada to the investigational product Probuphine and, has provided Titan a $15.75 million upfront payment and entitles the company to up to $215 million in milestone payments plus tiered double digit royalties on Probuphine sales. The milestone payment from Braeburn in the event of FDA approval of Probuphine for the treatment of opioid dependence will be $50 million since the NDA has received Priority Review designation.

    About Opioid Addiction

    It is estimated that there are 2.3 million opioid addicts in the U.S. Approximately 20 percent of this potential patient population is addicted to illicit opioids, such as heroin, and the other 80 percent to prescription drugs, such as oxycontin, methadone, and codeine. Until recently, medication-assisted therapies for opioid addiction had been sanctioned to a limited number of facilities in the U.S. Today, physicians can be certified to prescribe certain opioid addiction medications in an office setting, which has greatly expanded patient access to opioid addiction pharmaceutical therapies. As a result, it is estimated that there are approximately 750,000 people in the U.S. receiving medicinal treatment for opioid addiction.

    About Probuphine®

    Probuphine is an investigational subcutaneous implant capable of delivering continuous and persistent, around the clock blood levels of buprenorphine for six months following a single treatment, enhancing patient compliance and retention. Buprenorphine, an approved agent for the treatment of opioid dependence, is currently available in the form of daily dosed sublingual tablets and film formulations, with reported 2011 sales of $1.3 billion in the United States.

    Probuphine was developed using ProNeura™, Titan's continuous drug delivery system that consists of a small, solid rod made from a mixture of ethylene-vinyl acetate (EVA) and a drug substance. The resulting construct is a solid matrix that is placed subcutaneously, normally in the upper arm in a simple office procedure, and removed in a similar manner at the end of the treatment period. The drug substance is released slowly, at continuous levels, through the process of diffusion. This results in a constant rate of release similar to intravenous administration.

    The efficacy and safety of Probuphine has been studied in several clinical trials, including a 163-patient, placebo-controlled study that demonstrated clinically meaningful and statistically significant treatment benefits with Probuphine over a 24-week period (published in the Journal of the American Medical Association (JAMA)), and a confirmatory study of 287 patients that showed statistically significant improvement in efficacy versus placebo, and non-inferiority with a currently marketed sublingual formulation of buprenorphine. Results of the confirmatory study were announced in July 2011. Probuphine was well-tolerated in all clinical studies, including in two open label safety studies that provided treatment with Probuphine for an additional six months to patients who completed the six-month controlled study.


    Article Date: 04 Jan 2013 - 0:00 PST
    http://www.medicalnewstoday.com/releases/254568.php
    Via: JAMA

Comments

  1. bitrat
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    Nice.....should have analgesic applications too.....
  2. ex-junkie
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    I wonder if a person had, for example, terrible joint pain; whether the probupine implanted close by would alleviate the pain in a person who would otherwise be doomed to a life addicted to pain pills.
  3. Basoodler
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    I wonder what the plan is for a person who has an implant has an accidental injury and is in need of opiate pain killers. I get that the patch is removed, but they still have to clear the bupe from the receptors right? There pi probably is a quick way and I'm not aware of it.

    As far as rehabilitation goes I think the is a huge step in the right direction.. For obvious reasons ..

    I wonder if ppl will cut them out to use again?


    Its amazing they can fit 6 months supply into that little implant
  4. ex-junkie
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    A person with a buprenorphine implant will need to wear a medicalert necklace or bracelet, in case they are unable to communicate that they have the implant in an emergency. There are alternative methods of pain relief that can be used, for example; general anaesthesia medications can be given in sub-anaesthetic levels and they work quite well for pain relief. Ketamine infusions are often used in emergency/post-surgical situations these days, in Australia at least.

    You, as a consumer, would need to seriously weigh up the risks vs benefits. However, if you live in a city, you would have access to a really good pain specialist team at your local hospital who would manage your pain quite well with the above mentioned alternative methods. If you live in a small, regional or remote town, then it's likely that the pain specialist team will do a very shit job of managing your pain. If this is the case and/or your health care services are pretty shit, then you'd probably just opt to get them to cut out the implant in the first instance. This is where it will be handy to have an Advanced Health Directive made up with your doctor - give it to your next of kin and be aware that these usually need updating every twelve months in order to remain a legal treatment outcome in the event of an emergency.

    In saying this, pain can still be managed using opiates, for example, when a person uses buprenorphine patches. However, this is best managed by a pain specialist team who knows what they're doing and who place you in a ward that has strict regular respiratory obs to monitor for and respond to respiratory depression.
  5. bitrat
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    Good point - the antagonist effect might interfere with sedation in an ICU.....also, it'd be a little scary knowing you're carrying a lethal dose - if the plastic suddenly degraded or something. I suppose this is the ultimate in compliance (sigh). Well, it seems like a good idea......but then again, the sine wave of increase and decrease of dose is missing - wonder how this would affect your circadian rhythms?
  6. Basoodler
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    Fda action is in April. I wonder how fast they roll it out. Also would doctors adopt this method over the single dose forms? It has a ton of upside from a doctors perspective I'm sure. Also it seems like a more logical rout to take from a rehabilitation perspective. I wonder if it tapers itself at the end of the 6 months?

    I'm sure there are some users who would probably like to avoid it though
  7. DOG-CHOPPER
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    Don't let you friends know if you happen to get one. A 6month supply of bupe could in the eyes of some be worth stealing.

    Hope the doctor doesn't mistakenly put two in WOW!!!!
  8. ex-junkie
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    Are you implying that people would cut it out of a person's arm to use a rod that will at best be of subtherapeutic value unless reimplanted into the flesh of another person? Seriously now.. that's just dirty.
  9. Basoodler
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    While this could be the best thing to ever hit the prison system. Someone in the joint may be sick and desperate enough to cut one out.

    Sadly
  10. DOG-CHOPPER
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    Well i have personally seen inmates standing around waiting for other inmates that have just had their methadone dose ,cornering them and making them vomit to get their dose and sometimes filtering and injecting their vomit.

    So i see it possible.
  11. Basoodler
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    Given the low upkeep I bet that will be one of the first places its utilized. Hopefully its burried deep and or is tamper resistant. I would assume even with recovery outside those two things would be a priority. It wouldn't help a thing if people dug them out and could extract it.

    I guess that is probably covered.
  12. ex-junkie
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    I highly doubt they will use this in the prison systems. Sadly the doctors and nurses who work in the prison system find they are often not allowed to treat the patients how they would treat usual patients, due to political discrimination. Prisoners are heavily discriminated through government policy and generally this will not change unless the policies that are currently in place are reviewed and changed. Society and the government will just see probuphine as being a humane way of treating opiate addiction and they will probably not award this to people in prison. I am not saying this in a discriminatory manner myself, I am just communicating some facts with you. Dr Neil Beck writes a lot about this in his books on beating heroin/addiction/triple diagnosis, etc.

    Here is a link to a Probuphine study that I uploaded some time ago.
  13. Basoodler
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    Its kind of sad how that works in America. We call taking people who may be a bit off track and pushing them waaay off track rehabilitation. It is really a shame because some really good people get caught up, and once you are caught up its hard to get back out :( people will not hire, if they do hire you could probably make more money doing something illegal. not to mention all the rest of the shit that goes with it :(
  14. bitrat
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    Holy kitty katz! Forcing people to barf, then shooting it? They'd end up like those people doing krokodil in Russia.....injecting that would cause immediate shock - the hydrochloric acid and digestive enzymes would make the person very sick - metabolic acidosis, weird immune disasters from the enzymes, etc....and where are people getting needles inside? (don't answer that - i know - too much information! ;*0). And i'm afraid ex is right - the likelihood of being "rewarded" with drugs inside is pretty low...i know it happens, but most facilities simply won't continue your meds unless they absolutely have to (psychotropics ie antidepressants & antipsychotics excepted). In fact, in higher security venues you're lucky to get anything (see Atlantic articles about IDX Florence)....
  15. Basoodler
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    I just thought of something. Remember a couple of months ago some D-wads were putting ads all over the internet for their miracle cure. which consisted of a 7 week taper and some liquid vitamins... It was called Puridone, which was changed recently from purafyte .. I bet they saw the news release for this stuff and trademarked a similar name
  16. bitrat
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    LOL - the websites' still there ...a "proprietary formula" heh heh heh.....sure....no drugs, so it's cold turkey + vitamins....you can do that at home for free..
    Remember that program years ago where they'd anesthetize u, then give u massive naloxone doses while u were asleep? Supposedly you'd withdraw under anesthesia, then be clean when u woke up! Wow, talk about ridiculous.......
  17. DOG-CHOPPER
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    In some countries jail systems make more money dispensing bupe and methadone to inmates than any other form of income.

    Inmates are even offered entry into these programs for alcohol problems.

    I was asked if i wanted to go on the bupe program after i told the drug councilor i drank a six pack of beer a day. I was told that a six pack a day is borderline alcoholism and it would help me.

    Later a prison guard filled me in saying the jail system was paid about $750 every time bupe or methadone was dispensed and went on to say they made more money from dispensing drugs than any other means.
  18. ex-junkie
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    This just sounds like that particular prison taking advantage of a loop hole in bupe program funding. This is not reflective of the entire prison system as a whole, but a very good example of just one type of corruption that can be seen in the system.

    Unfortunately acute mental health settings and prison systems contain a proportion of society that nobody appears to give a fuck about. This saddens me because it means that they are not only failing the people who wind up in them, but they're failing society as a whole. The people who staff these facilities clearly don't give a fuck either and this angers me.

    For every 1,000 people who don't give a single fuck; there is 1 person who gives a fuck. These people who give a fuck are not likely to ever get to a higher position in which they can make some changes that might benefit the greater good of people, because they lose popularity fast for standing up for what they believe in/advocating for the people they care for/supervise. This has dawned on me in a big way of late and so I see the only way to make changes is to educate people in society (who also clearly don't give a fuck) and change policies on a political level (but we need to have people with bulk degrees and great public speaking skills to convince small minded politicans that change is necessary/give more funding).

    Above mentioned education and policy changes can therefore only come about with research that proves to small minded members of society that change is more cost effective and that treating addiction in prison systems will (hopefully) reduce crime. Of course this is common sense really, but we live in a time where we need scientific proof that these things will actually work before anybody is going to fork out extra funding to implement new treatments. However, this all comes into conflict with existing research that people are more likely to be repeat offenders and relapse, so it's a slippery slope. Some might assume that probuphine will just be cut out upon release and that addiction and crime will be resumed, and unfortunately this will be the case for some; possibly many. This therefore would make the average member of society cross that offenders have a more comfortable stay in the prison system and make them not want to award this 'luxury' at all. It is common for members of society to want or expect people in prison to suffer while they are in there.

    This is my long thoughtful post for the day.
  19. bitrat
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    Hmmm....sounds like you've been there! Me too....Have to agree...... prison, or at least county jail (which you probably know are not the same - most people that have to do real time prefer prison because, as rough as it can be, most state prisons have actual programs.......classes, group therapy, sometimes musical instruments, more books, actual work, etc etc.) really beats sitting in a county lockdown for months or years....But you're totally right about treatment being considered a luxury......and it is.....so of course the first thing an addict will do upon release is reach for a fix.
    As u pointed out so cogently, jail has become the safety net for the homeless, mentally disturbed people, you name it......the "dual diagnosis" people (substance abuse plus psychological problems) are overrepresented there....Many people blame Reagan and i'm sure he contributed, but it's been a direction of our society for many years, and as the economic situation worsens the social institutions will continue to disintegrate as well....
  20. ex-junkie
    Re: Probuphine: implant that provides 6 months buprenorphine in one treatment: FDA pr

    I've never been to jail, but I recently spoke with some health professionals about their frustration at being unable to truly help people in the prison system because the government policies prevented them from treating their patients with conventional methods. There would definitely be addiction treatment protocol/policies and procedures that would need to be followed in each facility and these would be based on state and federal recommendations. There would be no addendum or room for any other methods of treatment until a policy review. If you've ever worked in any type of community services position, then you would realise how futile even a policy review can be on an organisational level; let alone on a state or federal level.

    Policies and procedures are notoriously out of date, or hard to retrieve in these sectors and when the review date approaches, depending on the integrity of the person/people in charge of reviewing/updating them (IF someone gets off their arse and does it), sometimes they are just reprinted with a new prospective date for renewal. For example, if they expired on nov 2011 and someone finally got around to 'updating' them in september 2012, that person might just reprint them with a 'date of next policy review, september 2013'; without actually having changed a thing. Usually it's only when the government bring in mandatory changes to certain sectors that they actually bring em out and rewrite them. Or if they know they're due to be audited...
To make a comment simply sign up and become a member!