FDA Approval of the first once a month medication for Opioid Dependence

Alkermes Announces FDA Approval of VIVITROL® for Prevention of Relapse to Opioid Dependence

~ First Once-Monthly Medication for Opioid Dependence ~

WALTHAM, Mass., Oct 12, 2010 (BUSINESS WIRE) -- Alkermes, Inc. (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved VIVITROL® (naltrexone for extended-release injectable suspension) for the prevention of relapse to opioid dependence, following opioid detoxification. VIVITROL is now the first and only non-narcotic, non-addictive, once-monthly medication approved for the treatment of opioid dependence. VIVITROL was approved by the FDA in 2006 for the treatment of alcohol dependence and should be used as part of a comprehensive management program that includes psychosocial support.

"Opioid dependence is a serious and chronic illness characterized by high rates of relapse," stated Dr. Marc Fishman, Assistant Professor of Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine. "VIVITROL is an opioid-blocking medication that offers patients and physicians a once-monthly medication to prevent relapse to opioid addiction."

"As an organization that helps families find treatment and offers support for loved ones with addiction, we see firsthand that opioid dependence is one of the most significant health issues facing our nation. This new indication for Alkermes' product as a non-addictive approach to prevent relapse to opioid dependence brings new hope to the families we serve," said Steve Pasierb, President and Chief Executive of The Partnership at Drugfree.org.

"Opioid dependence is a growing disease and we believe that VIVITROL offers physicians and their patients a whole new approach, as the only long-acting, non-addictive treatment for opioid dependence," stated Richard Pops, Chief Executive Officer of Alkermes. "We look forward to helping to improve the lives of patients with this chronic and debilitating condition."

The FDA approval of VIVITROL for the prevention of relapse to opioid dependence was based on data from a six-month, multi-center, randomized phase 3 study which met its primary efficacy endpoint and all secondary efficacy endpoints. Data from the intent-to-treat analysis showed that patients treated once a month with VIVITROL demonstrated statistically significant higher rates of opioid-free urine screens compared to patients treated with placebo (p<0.0002). VIVITROL was generally well tolerated in the study. The most common clinical adverse events experienced by patients receiving VIVITROL during the study were hepatic enzyme elevations, nasopharyngitis and insomnia.
Alkermes.com

I am curious to see what everyone else thinks about this new approval. Do you think this is something that you would be willing to try in your recovery?

I have done some reading on Vivitrol and have posted that information below.

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.
http://investor.alkermes.com/phoenix.zhtml?c=92211&p=RssLanding&cat=news&id=1481879

So. What do you think? Yay, nay, or undecided?

FDA Approval of the first once a month medication for Opioid Dependence Audrey10

Hello to Dee & all!! cheers

I am not quite sure how it was that I missed this post, but I did happen to catch it this morning & first off, I wanted to thank Dee for providing us with this newest up-to-date information regarding opioid maintenance!! Like a Star @ heaven

It is amazing to me the strides that are FINALLY being made to help people with this disease of opiate addiction to be able to control it. It used to be that you either had to suffer it out or your only other option for long term maintenance was Methadone. I realize that Methadone has saved millions, if not billions of lives, but also taking into consideration that it WAS the ONLY maintenance medication available for the longest time. Now the times, they are a changing! Thank you Lord! I am not opposed to Methadone, especially in the circumstances of pain control, yet I am much more of an advocate for NON-addictive maintenance medications. Methadone is still able to be abused & knowing myself, if I were to have gone onto it rather than the Suboxone, I cannot honestly sit here today & say that I would NOT be abusing it if it made me feel so good that I wanted to continue to take more & more of it for that euphoric feeling. Twisted Evil

Therefore, despite all of the times in the past that I have attempted to quit using, but not going onto a maintenance medication, I hate to have to admit that I had failed every time & began using again. This is my 2 1/2 year mark of being in recovery, off of all opiates & the Suboxone has been what has aided me to remain in recovery to allow my brain the chance & time to heal those receptors that used to haunt me!! pale

For a very long time, well really since I started taking it, I have referred to the Suboxone as a "life saving, miracle medication" that I KNOW has saved my life! I didn't ever even take into consideration that there could ever even be more options out there that would work like Suboxone does or that there could even be something better to come! Please don't take that the wrong way, as I do not KNOW about this new VIVITROL or am I saying that it works better (or even the same) than what Suboxone does, I am just impressed that there is yet another medication for long term maintenance that is only taken on a monthly basis! How great that would be if it does have the same effectiveness of Suboxone, but only having to take it on a monthly basis rather than everyday! I also believe that if this new option of VIVITROL works as effectively as the Suboxone does, then there would be much less opportunity for Suboxone to hit the streets. I don't believe that the article stated if it was a plll or a dissolving tablet or an injection or how it would be taken, but if you already see your doctor (Provider) once a month, you would be able to get your dosage right then & not have to worry about it again until the next appointment. Just like waiting to go see your Provider for your next month's prescription. I do have a concern though that I would certainly discuss with my doctor before ever attempting to switch to the VIVITROL & that is mainly wondering if it is stored within your fat cells throughout the month or where is it stored within your body? And my main point for this question is that obviously people have different metabolism rates, so ASSUMING that it would be stored within the fat cells, what if your body metabolizes the medication quicker than within that one whole month?? Would that person be suffering throughout the last week or so until it came time to get your next monthly dosage? Just a thought I would have to ponder upon... and DEMAND answers before switching to a new medication when the one that you are currently on is working well for you or I. Personally, I would rather take a medication on a daily basis knowing that it will continue to work for me than to switch to a new one that leaves me miserable for the last week or so of the month. And I have NO verification that this is even the case, I am just trying to think it all through. So please know that these are only MY thoughts & opinions- NOT PROVEN FACTS!

What is FACT is:

"Opioid dependence is a growing disease and we believe that VIVITROL offers physicians and their patients a whole new approach, as the only long-acting, non-addictive treatment for opioid dependence," stated Richard Pops, Chief Executive Officer of Alkermes. "We look forward to helping to improve the lives of patients with this chronic and debilitating condition."

As I think that we all know by now how true that statement is.. But this Richard Pops, the CEO of Alkermes, has stated that this is "a chronic & debilitating condition" & he is providing opiate addicts another option besides Suboxone or Methadone for recovery. Not to mention that he has also included within this article that the medication itself is NOT enough, but also counseling. I believe that many people go onto these medications, but do not go to talk with a counselor or even attend any type of group interaction that is proven to be the most effective opportunity for recovery. We all have scars from our addictions that will need addressed sooner or later, depends on how long you want to hold onto it all.. Personally, I want mine to be gone NOW!! I know patience is a virtue & I am working hard on that aspect of myself, but as we all know, when we want it, WE WANT IT NOW!! As I said, I truly am trying to work on that about myself & anything else that needs improving. I want to strive to be better & that helps keep my chin up to get through yet another day!

Anyways, I will close this up for now with a new happiness that our addictions have yet another option to help keep us in our recoveries & that this disesase is finally being handled & acknowledged as it should have been long ago, treated with the most effective ways possible right now. I believe that NOW they will continue to come out with better & better ways of treatment, as they have begun to understand the concept of this disease within the brain & how to counteract it. Medical technology at its finest.

Thanks again for sharing Dee & to everyone who read this lengthy reply!! lol!

Yours throughout this journey,
~Beth I love you

Hi again-

Okay, I wrote my post before I read Dee's newest post above & upon reading more about this injection, I am likely so say "NAY!"
I cannot post any longer right now, but I will be back with my reasonings why.

~Beth I love you

I would like to point out a few things about the new medication. Well actually Vivitrol is not new on the market but new for Opioid Dependence.

In reading the fact about the medication I noticed that it said,VIVITROL is contraindicated in patients with acute hepatitis or liver failure, patients receiving opioid analgesics, patients with current physiologic opioid dependence.

So what exactly does this mean? Can we as addicts take this medication and expect success or not?
I was concerned as to what the term "physiologic opioid dependence" meant. Our moderator on our Methadone forum has posted this article as well to get some feedback from the patients there.
As RuthAnn has point out:
so physiological opioid dependant people 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.
The URL to our Methadone Forum "A Flicker of Light in The Dark" here is the link:http://methadone.forumotion.net/announcements-events-and-breaking-news-f1/fda-oks-vivitrol-to-treat-heroin-narcotic-addictions-t634.htm#1269
She has a point and like Beth, I would have to say not for me.

Sorry, still in a hurry today, yet the more that I read about it & as Dee pointed out a few of the phrases that caught my eye as well, my response is only "NAY!" If I am doing well with where I am, then why change it when it is working??? Idea

Only my opinion...

Gotta go pick up my girl from school!

~Beth I love you

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