Opioid Use Disorder:  Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment; Draft Guidance for Industry; Availability 
CDER 2018-300 Opioid Use Disorder:  Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Draft Guidance for Industry Availability OPEN
2018-08-14 2018-08-14 2019-03-07 2018-10-09 2018-09-25 2018-08-09 2018-10-18 2018-09-04
FDA-2018-D-2382-0004 FDA-2018-D-2382-0005 FDA-2018-D-2382-0017 FDA-2018-D-2382-0008 FDA-2018-D-2382-0007 FDA-2018-D-2382-0003 FDA-2018-D-2382-0016 FDA-2018-D-2382-0006
04:00:00 04:00:00 05:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2018-D-2382-0004 https://api.regulations.gov/v4/comments/FDA-2018-D-2382-0005 https://api.regulations.gov/v4/comments/FDA-2018-D-2382-0017 https://api.regulations.gov/v4/comments/FDA-2018-D-2382-0008 https://api.regulations.gov/v4/comments/FDA-2018-D-2382-0007 https://api.regulations.gov/v4/comments/FDA-2018-D-2382-0003 https://api.regulations.gov/v4/comments/FDA-2018-D-2382-0016 https://api.regulations.gov/v4/comments/FDA-2018-D-2382-0006
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
I dont think that every person should be treated the same and have to go by the same guidelines! Every person is different and have different problems going on. As a 47 yr old grandmother I believe that i was treated as if i was some kind of drug addict!! I have been on opioid pain medication for several years. i have have several medical problems- which include partly of chronic pain, fibromyalgia, severe bone deterioation, 2 slipped disc in my back, had 2 complete knee replacements, sciatica, and the list goes on.  I went to all my appointments, complied with all the rules and was told they needed to cut me back because the according to the fda rules i was over medicated!  it became harder and harder for me to get my medication, and i was treated like a common drug addict because of the fda laws and rules! i dont think i was treated fairly by any means!!!! i am almost 50 yrs old and wish my life was not as it is.  I am also in end stage renal failure, so i get dialysis 5 days a week and when a person   is on dialysis it takes most of the medication out of your system  so by the time i had built anything up in my system I would be dialyized so i had to start all over again the next to get anything built up!!!! The fact that i was on dialysis had NO play in the factors of how much medication i was allowed a day.I dont think the same rules should apply to every person since everyone has different circumstances for the reason they are medicated. I wish Jeff Session would have to live a day in my shoes then have someone tell him NOPE your too medicated! So i believe each persons circumstances should be taken into consideration.  when they are prescribed pain medication., especially if they have YEARS of medical documentation of reasons fffor being on the the medication. And with all the new rules laws surrounding being on opioids it has made it just about impossible to get any help! Unless I want to pay 100s of $ because many pain doctors do not take insurance anymore I dont think that every person should be treated the same and have to go by the same guidelines! Every person is different and have different problems going on. As a 47 yr old grandmother I believe that i was treated as if i was some kind of drug addict!! I have been on opioid pain medication for several years. i have have several medical problems- which include partly of chronic pain, fibromyalgia, severe bone deterioation, 2 slipped disc in my back, had 2 complete knee replacements, sciatica, and the list goes on. I went to all my appointments, complied with all the rules and was told they needed to cut me back because the according to the fda rules i was over medicated! it became harder and harder for me to get my medication, and i was treated like a common drug addict because of the fda laws and rules! i dont think i was treated fairly by any means!!!! i am almost 50 yrs old and wish my life was not as it is. I am also in end stage renal failure, so i get dialysis 5 days a week and when a person is on dialysis it takes most of the medication out of your system so by the time i had built anything up in my system I would be dialyized so i had to start all over again the next to get anything built up!!!! The fact that i was on dialysis had NO play in the factors of how much medication i was allowed a day.I dont think the same rules should apply to every person since everyone has different circumstances for the reason they are medicated. I wish Jeff Session would have to live a day in my shoes then have someone tell him NOPE your too medicated! So i believe each persons circumstances should be taken into consideration. when they are prescribed pain medication., especially if they have YEARS of medical documentation of reasons fffor being on the the medication. And with all the new rules laws surrounding being on opioids it has made it just about impossible to get any help! Unless I want to pay 100s of $ because many pain doctors do not take insurance anymore There should be clear and unambiguous language that placebo control trials should not be designed. All endpoints should be compared to a standard of care; either buprenorphine or methadone treatment. Superiority or non-inferiority studies should be standard practice.  We approve of the FDAs assistance with the nation-wide epidemic concerning opiods. The guidance set forth by the FDA assist sponsors in developing drugs for a medication-assisted treatment of opiod use disorder, which could greatly reduce the growing number of deaths this nation faces everyday. The trials outlined are closely monitored and the patients are frquently assesed for adverse events, whcih the guidline outlines. The Guideline also specifically outlines the way a sponsor could report an outcome and change in drug use pattern. Overall, the guidance tackles the issue of the opiod epidemic and provides assistance for those trying to help. The guidance also allows for a more uniform breakdown in outcomes of patients and a variety of endpoints that can be reached. We approve of this guidance and the work of those involved to help those in need. People who abuse drugs and become addicted  will always find a way to get high whether the drug is legally prescribed or not . Chronic pain patients shouldnt be punished for addicts bad decisions . Youre killing me witholding medicine to improve the quality of my life . I am in control of my actions . I never abused drugs. I never failed drug tests , I am always compliant with pain contracts for 16 yrs ! I am not an addict !  Stop the torturing of people who live their lives in pain. You are destroying my quality of life ! Youre destroying my familys quality of life ! Would you watch your mother , Father  or your child scream in pain day after day ? I seriously doubt you would .I am a human being ! Treat me like one ! End the ridiculous  War on Drugs ! It didnt work for alcohol ! Speaking of alcohol. Not everyone who drinks it becomes an alcoholic . Since Subutex is an opioid medication used for medication assisted addiction treatment, I am assuming comments regarding that medication are welxome too. Subutex has saved my life. I was using extremely dangeous amounts of other opiates daily and after receiving Subutex, I have not touched another drug or opiate! Personally, I feel Suboxone, Bunavail and Zubsolv are all a joke. They are NOT as effective as the plain Buprenorphine and I am deathly allergic to them and no one knows the issues the long term use of Naloxone may cause and many people are becoming immune to it which means more people will die from overdose. I feel the Naloxone should be REMOVED from the medications and just plain Buprenorphine be administered. Another issue is, pharmacies are refusing to fill prescriptions for Buprenorphine for people because they say they dont carry the medication, cannot accept new patients or just because they dont want to. Also many pharmacies REFUSE to accept insurance for Buprenorphine but will accept the same insurance for any other medications they carry and this seems like it should be illegal. I had to go to mail order through OptumRX for this reason and I have to do a few days without my medication. There should be NO LIMIT on the number of patients a pharmacy can have. Also pharmacies should have to bill your insurance for Buprenorphine if they accept the insurance for ANY medication! Another thing is, pharmacies should have to fill prescriptions written by doctors in their state whether the patient resides there or not and a patients home state should honor a prescription written in any state. People seeking treatment cannot get their medications filled and its RIDICULOUS. Its time someone steps in and makws it easier to obtain medication for addiction treatment. Getting a prescription is easy but getting it filled is impossible and more people are going back to street drugs but unfortunately they have no choice.The FDA needs to step in and help out. These medications with Naloxone need taken off market and some studies done on them. They are terrible medications. Suboxone is a horrid medication that is actually dangerous and so are its alternatives! Something needs done with making access to treatment for addiction and getting addiction treatment medications filled at pharmacies easier. The restrictions need lifted and pharmacies need to fill peoples medications without the hassle. I personally checked at 100 different pharmacies in PA, WV, MD and OH trying to get my medication filled with no success. I either had to pay xash when my insurance does pay for it, they said they werent taking new patients, didnt carry it and refused to order it or just plain refused because they did not want to or because I live in WV or because my doctor is in PA. Its impossible for people trying to actually get clean and better themselves to get their medications! We need help! Research should reflect real world situations in order to make measurable improvements in the context of the current epidemic.  1)Typically, 70-80% of those with SUD are using multiple substances.  In light of this, published research should not simply include benefits for the target drug (e.g., opioid, alcohol, etc.) but for the full spectrum of substance use behaviors.  Failure to do so risks known increases in other drug use when one pathway is blocked as seen in the recent article by Tanum et al. (2017) which found an increase in cocaine and benzodiazepines in the buprenorphine treatment group.   2)Typically, most individuals on medication assisted treatment discontinue medication use within the first few months (Morgan et al., 2017).   In light of this, outcomes should include longer term measures, and include improvement that continues after cessation of the medication, just like penicillin or nicotine replacement.  3)Typically, like remission rates of other illnesses such as cancer, recovery rates increase with longer lengths of cessation of drug use up to five years.  In light of this, effectiveness should be measured with outcomes no less than one year, preferably three years, in order to obtain results that are most reflective of benefit to the long-term outcomes. 4)Typically, like taking half a dose of penicillin, improper treatment can lead to short term gains but longer term widespread worsening of the condition.  Therefore, while short term outcomes are beneficial for interventions such as naloxone, with medications intended to treat substance use disorder, there should be long term measure of the improvement. 5)Placebo controlled trials are the gold standard of research, and necessary research designs in order to determine that one approach is better than another.  However, in the context of opioid agonist medications, it is impossible to design such an experiment, since individuals will know they received a placebo when they start experiencing withdrawal from the opioid.  This is problematic in determining efficacy, and therefore conclusions should be appropriately tempered. Comments should be added to reflect these research related outcome issues. Thank you for your consideration.  re:  Medications intended to provide symptomatic relief of opioid withdrawal are not considered46 treatments for OUD, but these medications may be useful as an initial step in bringing patients47 into treatment with drugs intended to reduce the risk of returning to illicit opioid use.49 Efficacy trials of medications for the treatment of OUD have typically employed a randomized,50 blinded, controlled trial design. For medications intended for use as initial therapy, patients are51 generally new entrants to treatment (i.e., actively ill and not currently receiving other drug52 treatments for OUD), and these trials employ active controls with a superiority or noninferiority53 design. Designs generally incorporate standard-of-care nonpharmacologic treatments as well as54 active medications available on a rescue basis, with patients requiring rescue transferred out of55 the protocol to standard care. For medications intended to reduce the risk of relapse, patients56 already stable on other treatments are studied, and in general, the comparator should be an57 approved therapy. rescue treatments are critical; as with any disease, continued pharmacologic treatments are equally critical to engage the person in treatment and sustained health. 