Monday, November 15, 2010
Vivitrol Approved for Opiate Addicts!
The treatment options for patients with an addiction to opiates - Heroin, Percocet, OxyContin, Methadone, etc. - have been very limited. Patients who try to go drug free have not been very successful because the pull back to the opiates is so high that almost everyone relapses within the first three months. The relapse rate is so high in fact that, many years ago, the government essentially gave up on the idea that most patients could go drug free and recommended giving them a highly addictive substitute drug called Methadone. Finally, this month the FDA has now approved Vivitrol – a monthly injection of Naltrexone that helps patients stay off drugs. What are its strengths and weaknesses and how will it fit into the treatment landscape?
Naltrexone is a powerful opiate blocker. If patients just took it, Naltrexone would completely prevent them from relapsing. But patients don’t take it. It doesn’t make much sense, but study after study has shown that patients don’t take oral Naltrexone. It has been available in an oral form since around 1982. The pills last about 24 hours and they definitely do work. But patients don’t take them. It is hard to understand why patients wouldn’t take a medicine that can completely prevent them from relapsing back to Heroin or OxyContin, but they don’t. The only way I can think about it, is to just accept this fact as evidence of how amazingly powerful the addiction process is. If there was a pill that prevented cigarette smokers from smoking, would they take it? It is an interesting question, and now there is somewhat of an answer. Chantix is a pill that blocks nicotine and is now approved for use with cigarette smokers. It does block the effects of Nicotine but the research shows that, at the end of 12 months, only about 7% of smokers are still quit. So maybe the experience with Naltrexone is not so different.
For over 30 years, physicians have realized that if they could just force patients to take their Naltrexone, then the patients would stay off heroin and other opiates. Some research was done with prisoners and sure enough since the prisoners were forced to take it, they stayed off drugs. But this is unrealistic in the real world. Early research was done around 1980 with long lasting Naltrexone injections but there was some tissue reaction and the research was abandoned. Then some Naltrexone implants came on the market and a few physicians started to use them. Here at the Coleman Institute we started to use Naltrexone implants around 1998 and we have been using them ever since. We have had great success. Patients usually lose all cravings and seem to recover from their post acute withdrawal symptoms quicker. Over the years better implants have come along. The original implants lasted only 4 – 6 weeks. We are now using implants that last over 3 months in half of the patients, and we are about to start a small research study on implants that may last 6 months.
Now Vivitrol has been approved by the FDA for the treatment of opiate dependence. Vivitrol is a one month injection of Naltrexone microspheres. It is a pretty cool technology. The Naltrexone is mixed with poly-lactates. Lactic acid is a natural breakdown product in the body so it is very safe. Poly-lactates are molecules where the lactic acid has been linked together into a chain which takes the body some time to break down. Poly-lactates are used in absorbable sutures. To make Vivitrol, the company takes poly-lactate powder and mixes it with Naltrexone powder and then makes the final powder into small spheres – micro spheres. The microspheres are small enough to go through a syringe and large enough to take one month to fully break down and release their Naltrexone. The result is a medicine that can reliably deliver Naltrexone for one month.
Like all medicines Vivitrol has some advantages and some disadvantages. It is an injection which means patients can’t not take it. It reliably gives them Naltrexone for a whole month. One advantage is that Vivitrol treatment is easier for patients than our implants - just a simple injection. Also if patients have insurance there is a chance the Vivitrol may be covered, although it is not clear yet just how generous the insurance companies are going to be. The medicine is very expensive.
On the negative side is the fact that once Vivitrol is injected into the body, it can’t be taken out. The Naltrexone implants we use can be removed in the rare situation that patients need to get narcotic painkillers. With Vivitrol you really have to wait one month until it wears off before you can get any pain relief. While this is rare, it did happen with one of our alcoholic patients last month. He got an implant but started drinking again and developed pancreatitis. Pancreatitis is extremely painful. Fortunately for him he had an implant and we were able to have it removed, so within 24 hours he was able to get good pain relief.
Vivitrol is also very expensive. Without insurance, it usually costs over $1100 for one month of treatment. I don’t know of many patients who will be willing to pay $1100 month after month. Our Naltrexone implants are only about $250 per month which is much more affordable and is actually much cheaper than most Methadone programs.
A very important thing to know about Vivitrol is that patients must be fully detoxified before they can start on it. If patients start on any form of Naltrexone while they still have even tiny amounts of opiates in their system they will go into complete withdrawal which is very painful and can be very dangerous. Getting patients fully detoxified so they can get started on Naltrexone is not easy. Suboxone is now being used by some doctors for detoxification, but it is a very long lasting opiate and so patients need to be off Suboxone for at least 14 days before they can start on Naltrexone. Most patients will relapse back to their street drugs before the 14 days is up and then they can’t start on Vivitrol.
We have over 12 years experience now in helping patients detoxify before they start on Naltrexone therapy. Most patients are simply not able to detoxify themselves and need medical assistance. Our Accelerated Opiate Detoxification (AOD) program uses light sedatives and other medicines to make patients comfortable and actually speed up the detox process. It is an outpatient program that patients find very easy to complete. Our success rate in getting patients onto Naltrexone is over 98%.
In summary, I think it is fabulous to have Vivitrol available for opiate addicts. It works well and will be a good option for a lot of patients who don’t want to be on Methadone Maintenance or Suboxone Maintenance. Some patients will be lucky enough to have the medicine covered by their insurance plan, but others may be able to use Naltrexone Implants as an alternative. All physicians and patients will have to be very careful to make sure that patients are fully detoxified before they start on this new treatment.