FDA OKs Vivitrol to treat heroin, narcotic addictions

This article comes from USA Today and the original link is

http://www.usatoday.com/yourlife/health/2010-10-14-opioid14_ST_N.htm

It will be interesting to see how well this medication works for addiction. But once again did you notice the COST??? Over $1,000 for ONE monthly dose? geesh, that ends up being more expensive than MMT for SURE. What also struck me was the quote from the director of the drug abuse institute where she says "There are treatment programs that really oppose using methadone or bupenorphine," says Nora Volkow, director of the drug abuse institute. "I predict that naltrexone may be acceptable." Anyhow, read the article for yourself and I would love to hear what you guys think.


FDA OKs Vivitrol to treat heroin, narcotic addictions


The Food and Drug Administration has approved a new treatment for addiction to heroin or prescription narcotic painkillers.

Vivitrol differs in two main ways from methadone and bupenorphrine (Suboxone), the two other drugs used to treat narcotic, or opioid, addiction. About 810,000 Americans are addicted to heroin, 1.85 million to opioid painkillers such as OxyContin, the National Institute on Drug Abuse says.

Vivitrol is injected monthly, not taken daily by mouth, so it's easier to stick to. Though patients can obtain bupenorphrine at a pharmacy, they must go to clinics daily to get methadone. And, unlike methadone and bupenorphrine, Vivitrol isn't an opioid but a long-acting form of naltrexone, which blocks opioids. "There are treatment programs that really oppose using methadone or bupenorphine," says Nora Volkow, director of the drug abuse institute. "I predict that naltrexone may be acceptable."

The FDA approved Vivitrol in 2006 for treating alcohol addiction. More than 45,000 people have been on it, some for more than four years, according to Alkermes, the Waltham, Mass., company that markets Vivitrol. Doctors can prescribe drugs "off-label," but few have used Vivitrol, which lists for $1,100 per shot, to treat opioid addiction, Alkermes CEO Richard Pops says. "This is such a new market."

The study that led to FDA approval of Vivitrol for opioid addiction involved 250 patients in Russia, the only other country in which it is approved for treating alcohol addiction. Russia has rejected methadone or bupenorphrine, Volkow says, leaving heroin "a major driver" of its HIV epidemic.

After six monthly shots, 70% of those who got Vivitrol hadn't gone back to using narcotics — double the rate of patients who had received a placebo. "I was concerned that the patients would not go back for their monthly injections, but they did, which was surprising," Volkow says. Also surprising, she says, was that Vivitrol reduced cravings for narcotics, for reasons that aren't yet clear.

T.J. Voller, 29, of Westborough, Mass., tried bupenorphrine with "sporadic success." By last December, he says, he cashed in his 401(k) and spent $17,000 on heroin in a month. He then found a doctor who'd give him Vivitrol. "It takes the cravings away," says Voller, who has had eight shots and now works and attends college. "I've had (heroin) in front of my face and haven't had the urge to do it. It shocked the hell out of me."

I am interested to see how this medication is able to take away the cravings for opiates since it is not a replacement therapy but an actual blocker. I am leary of any type of implant. What will happen if someone who has this implant needs emergency treatment in an ER and needs to be treated for pain? What if there isn't time to remove the implant? Do they somehow take the time to remove the implant so they can treat the patient? Or is there a way of medicating over the blocking affect of the Naltrexone?
Of course there are treatment programs that are against Methadone and Buprenorphine we hear that everyday, but the fact is that replacement therapy does work. I'm not trying to say this treatment won't work for some people but it won't work for everyone.
What about those of us who have tried many times to stop using only to go back to using? What about pain patients who became addicted to their medications but are able to not only control their pain with Methadone and Buprenorphine but manage their addiction as well? Will they be able to have adequate pain control with this new medication? The majority of addicts that I knew are people who suffer from chronic pain.

$1,000 is a lot of money to pay. The cost of Methadone and Suboxone is high enough. In some states medicaid will pay for treatment but a lot of the states that pay for MMT and Suboxone don't pay for Naltrexone. Table of states that pay for other treatments> http://www.ncsl.org/default.aspx?tabid=14144
I know that I have a lot of "what if's and what about's but it's how I feel.

This one isn't actually an "implant", it is just an injection of Vivitrol (naltrexone) once a month. But it would probably have the same concerns as an implant in that once it's injected, it lasts for a month so anything you take on top of that for the rest of the month will be blocked.........thus if you have a medical emergency or something like that, what will you do? Sugeries that aren't emergency may can be scheduled so that you can take the shot later in the month after your surgery or something, but emergency situations don't fall in that category.

Also, like Dee said, what about cravings? Does it help take away cravings or is this just a matter of you still will have cravings but you just suffer through them until you finally give in and take what you want but the naltrexone ends up blocking the high?

Something else I have thougth about since I posted this, WHO is going to give the injection? Will you still have to go to a doc once a month and pay the dr fee on top of the fee for the medication? If so, I would rather continue my MMT therapy, going to the clinic once a month and paying $310 vs over $1000 the naltrexone shots cost, stigma about MMT be darned.

Your right RuthAnn it does say injection, I'm sorry. When I first read the article I read it wrong.
I apologize to everyone.
There is an actual Naltrexone Implant for Alcoholism and that is what I was thinking about.


I have some further information about VIVITROL.

About VIVITROL
VIVITROL is the first and only once-monthly, extended-release injectable medication for the treatment of alcohol dependence and opioid dependence. The proprietary Medisorb® drug delivery technology in VIVITROL enables the medication to be gradually released into the body at a controlled rate over a one-month time period.

VIVITROL IMPORTANT SAFETY INFORMATION

VIVITROL is contraindicated in patients with acute hepatitis or liver failure, patients receiving opioid analgesics, patients with current physiologic opioid dependence, patients in acute opiate withdrawal, any individual who has failed the naloxone challenge test or has a positive urine screen for opioids, and in patients who have previously exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose or any other components of the diluent.


Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.


Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.


The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. VIVITROL does not appear to be a hepatotoxin at the recommended doses.


Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of VIVITROL should be discontinued in the event of symptoms and/or signs of acute hepatitis.





VIVITROL is administered as an intramuscular (IM) gluteal injection. Inadvertent subcutaneous injection of VIVITROL may increase the likelihood of severe injection site reactions. VIVITROL must be injected using one of the customized needles provided in the carton. Because needle length may not be adequate due to body habitus, each patient should be assessed prior to each injection to assure that needle length is adequate for IM administration. VIVITROL injections may be followed by pain, tenderness, induration, swelling, erythema, bruising or pruritus; however, in some cases injection site reactions may be very severe. Injection site reactions not improving may require prompt medical attention, including in some cases surgical intervention.

Consider the diagnosis of eosinophilic pneumonia if patients develop progressive dyspnea and hypoxemia. Patients should be warned of the risk of hypersensitivity reactions, including anaphylaxis. Opioid-dependent patients including those being treated for alcohol dependence, must be opioid- free for a minimum of 7-10 days before VIVITROL treatment. Attempts to overcome opioid blockade due to VIVITROL may result in a fatal overdose. After opioid detoxification, patients are likely to have reduced tolerance to opioids. Use of lower doses of opioids after VIVITROL is discontinued, at the end of a dosing interval or after missing a dose could result in life threatening opioid intoxication. Alcohol- and opioid-dependent patients, including those taking VIVITROL, should be monitored for the development of depression or suicidal thoughts. As with any IM injection, VIVITROL should be administered with caution to patients with thrombocytopenia or any coagulation disorder. In an emergency situation in patients receiving VIVITROL, suggestions for pain management include regional analgesia or use of non-opioid analgesics. Patients requiring reversal of the VIVITROL blockade for pain management should be monitored by appropriately trained personnel in a setting equipped for cardiopulmonary resuscitation. Caution is recommended in administering VIVITROL to patients with moderate to severe renal impairment.

The adverse events seen most frequently in association with VIVITROL therapy for alcohol dependence include nausea, vomiting, injection site reactions (including induration, pruritus, nodules and swelling), muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders. The adverse events seen most frequently in association with VIVITROL in opioid-dependent patients include hepatic enzyme abnormalities, injection site pain, nasopharyngitis, insomnia, and toothache.
Alkermes.com

Thanks for more info Dee. I didn't know what HEPATOCELLULAR INJURY was, so I looked it up and this is INJURY TO THE LIVER. So excessive doses causes liver damage.

I also liked the part "VIVITROL is contraindicated in patients with acute hepatitis or liver failure, patients receiving opioid analgesics, patients with current physiologic opioid dependence, patients in acute opiate withdrawal.............." so physiological opioid dependant ppl shouldn't use it??? Hello? What the heck do they think is going on w/opiate addicts? I did some research and physiological dependence refers to the mental aspects of addiction so that says to me right there that this medication does NOTHING for cravings. I guess it works better for those who are only physically dependent on opiates not those of us who suffer physically and mentally.

Interesting...I don't know if I could have quit for 10 days to start this stuff. I do not think it would satisfy my mental cravings. I really don't think I would want to go to the clinic a month later. If my I was sick I would prob. want to use. I don't think this would work for me.

P.S. Thanks for sharing, it is always nice to hear about new ways to go about opiate addiction.