Request that the FDA refrain from approving any pending or future application for an opioid product submitted pursuant to section 505(b) or 505(j) of the FD&C Act, including NDA No. 209774 submitted by SpecGx LLC (“MNK-812”), with an indication or any other labeling that suggests that the product is appropriate for chronic use.
CITIZEN PETITION PHARMACEUTICAL MANUFACTURING RESEARCH SERVICES, INC. PMRS opioid product SpecGx LLC (“MNK-812”) abuse-deterrent labeling NDA No. 209774 Roxicodone Reference Listed Drug (RLD) chronic pain opioid addiction Citizen Petition (FDA-2017-P-1359) OxyContin 10 mg, 20 mg, and 40 mg tablets (NDA 20-553) CDER
2019-03-26 2019-03-04 2018-11-28 2019-04-05 2019-04-01 2019-04-11
FDA-2018-P-4338-0021 FDA-2018-P-4338-0020 FDA-2018-P-4338-0019 FDA-2018-P-4338-0023 FDA-2018-P-4338-0022 FDA-2018-P-4338-0024
04:00:00 05:00:00 05:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2018-P-4338-0021 https://api.regulations.gov/v4/comments/FDA-2018-P-4338-0020 https://api.regulations.gov/v4/comments/FDA-2018-P-4338-0019 https://api.regulations.gov/v4/comments/FDA-2018-P-4338-0023 https://api.regulations.gov/v4/comments/FDA-2018-P-4338-0022 https://api.regulations.gov/v4/comments/FDA-2018-P-4338-0024
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Im 46 years old  12 years ago my life changed forever. That was the year I had my 1st (up to 7  my neurosurgeon says about every 5 years I will need another) Spinal Fusion which was a disaster  left me with permanent Nerve damage  in Chronic Pain.  After so many surgeries  so much trauma involving my spinal Nerves I also ended up w a disease called CRPS. My pain is horrendous  I fight everyday just to get out of bed  to shower these days.  A year ago I wasnt this bad, I could actually go w my mom to a store  maybe lunch that day but now w the CDC laws my meds have been cut in half. So now its been 2 times in my life where I have lost everything  the most important part that was just taken away now was my quality of life. For 12 years Ive been on these opioid medications  Ive never had a medication emergency, never ran out earlier than I should, never changed pharmacies, etc. I followed every rule  now Im getting punished because of the addicts!! Its not fair...without meds or even life as it is now, Im only 46 years old, I cant live the rest of my life this way. Please dont throw the disabled  the chronic pain patients away. Our lives matter  Shameful request ! This kind of rhetoric is forcing millions of pain patients to suffer needlessly. After 20 years of Pain it was OxyContin that helpedmore than any other pain reliever. Stop this madness now. This commentary is in response to the citizen petition posted by Pharmaceutical Manufacturing Research Services, Inc. pertaining to pending and future approvals of opioid products. This commentary will be in response to two of the major requests posed in this petition; to no longer approve any opioid medication with an indication of chronic pain and to refrain from approving any opioid with abuse-deterrent labeling. It should be noted that the petition is certainly aiming to solve a major public health crisis; the abuse and misuse of opioid continues to rise in the United States and has resulted in an unprecedented amount of opioid overdose deaths. It has been a major goal of the current administration, the FDA and many public health organizations to have a greater control on opioid distribution and use and this commentary should not discount the continued efforts that are needed to combat the opioid epidemic. Instead, this commentary should be used to evaluate and strengthen the current arguments of this petition. As noted in the petition, chronic pain is defined as pain persisting for longer than 1 month beyond resolution of the underlying insult, or pain persisting beyond 3 months. While the petition calls to refrain from approving and other opioid medications for chronic pain, we should question if this medication could benefit end-of-life palliative care or severe chronic pain from serious illness such as cancer. An article in the AMA Journal of Ethics discusses the goals of a physician in end-of-life care and the use of opioids1. The article notes that a physician should aim to benefit the patient and minimize the burden of doing so, strive to preserve life and provide comfort in dying, and meeting individual needs and those of society. It could easily be argued that a new opioid, with immediate release technology, could provide comfort in dying to the patient and meet the needs of society, better than current opioids, by employing abuse deterrent technology. While it is important that we are cognizant of opioid addiction, it is also important to remember the intended use of these medications and ensure that individuals with chronic pain have fair access to all prescriptions availableThe second point of commentary is on the petitions request to refrain from approving any opioid product with abuse-deterrent labeling. Its important to properly label prescriptions and if advanced technology has been used it an effort to curb abuse it is proper to note that on the bottle. Its possible that another name should be used in place of abuse-deterrent, such as diversion technology, but manufacturers should be rightfully credited with this technology and there should be some notation on the bottle of the new formulation. Also, in rebuttal of the petition, there are current articles that note that abuse-deterrent technology is effective is reducing the possibility of both intranasal and intravenous use2. Immediate release tablets are designed to transform from a pill into gel when an abuser attempts to crush or inhale the pill. The gel will also cause a burning sensation if its attempted to be snorted intranasal in a greater attempt to deter this abuse. There are many thorough and well thought facts included in this petition and it should be thoughtfully considered by the FDA. Its clear that as a country, we need to be more conscious and considerate of the prescriptions that we approve and think about long-term implications before approving and NDA. Opioid use needs to be monitored more closely to deter abuse but it needs to be ensured that individuals with chronic pain have access to new medications and technology. We cannot deny patients in pain from their right to fair and just treatment and pain reduction. Sources:1. https://journalofethics.ama-assn.org/article/common-misconceptions-about-opioid-use-pain-management-end-life/2013-052.  https://www.ncbi.nlm.nih.gov/pubmed/29308593 I am a citizen of the USA I am 64 year old and am disabled since 2008 Before that i worked two jobs and never did drugs never smokes and on occasion drink a glass of wine or beer on a holiday or birthday.I am frustrated with the way I have recently been  treated by my doctors and medical staff because of our government ! I for many years have had Cronic pain with my fibromyalgia and arthritis with generative disc desease and other issues like depresion cronic anxiety .Thats enough as of now.I have been taken of my pain meds because of my anxiety medication mind you It has taken me many years to find the right combinations of medications and I have had no problem till now my phyciatrest has worked with me and other primary doctors to find something that works and that are in the so called guidelines now They have not been successful .I have also never misused My medicines I am not an addict  just a person in pain. My life has totally been turned upside down I am not able to watch my grand children or go to family functions because of all this I am not able to live the life I once lived It was not perfect but it was liveable I of coarse am not alone in this there are many more .They cry in pain and they feel alone because our government has failed them .We know there is a drug epidemic those that abuse and misuse even sell horrible drugs to innocent people even children But we should not be the ones targeted. 90 percent of senior citizens do not misuse or over dose on theres or someone elses medications .I AM LIKE I SAID SPEAKING FOR ME AND OTHERS LIKE ME THIS IS WRONG AND SOMETHING NEEDS TO BE DONE PLEASE HEAR OUR VOICES CALLING FOR HELP WE DO NOT DESERVE THIS IS UNCONSTITUTIONAL!  I am just one person that represents the chronic illness community. I feel like something that isnt mentioned in this discussion is that this is a last resort treatment for many of us. We dont abuse this medication and use it as directed as one pice of a multifaceted treatment plan that includes things like yoga and meditation.  I feel like if you truly want to address this issue the answer lies in finding better treatment for chronic illnesses. I dont understand the logic behind saying its appropriate for people not to deal with pain for a few days after surgery or an injury but not for chronic illness.  Pain is very distressing to the body which is the whole reason we use it as a treatment and long term distress causes more health conditions.  I cant speak for everyone but through the last 15 plus years Ive been dealing with chronic pain and illness I have gone off of opiates to try different medications and while opiates arent ideal no treatment is and for most of us they play a pivotal role in our ability to function everyday. Chemo isnt an ideal treatment neither is insulin, but when you are ill you only have the options available to you. Like anything there are people who exploit things to their benefit. I dont see how taking treatment that isnt being abused from an already vulnerable population. I agree these meds were being over prescribed but if there is any appropriate use for these meds it would be for chronic and terminally ill people who have to be on supervised treatment the rest of their lives. Many people start abusing these drugs due to the lack of info and oversight that has already transpired and cutting them off with no medical guidance. Taking treatment from those who have been using it appropriately would make an already vulnerable population absolutely desperate. We are not being represented or advocated for and would hope that we are not neglected and the decision will be left to the Dr and patient. This treatment is a big responsibility and should be treated as such. I see the top Dr in my state for my condition and he has been absolutely phenomenal in the guidance and treatment I have received from him and I feel grateful he wasnt a dr feel good and knows how to properly prescribe the lowest doses for as long as possible. I had been to drs prior to him that were totally over prescribing and I advocated that to the dr I see now.  My point is with chronic illness every moment of every day is a major task to overcome there are days I can barely get from my bed to the bathroom . Thats managing my illness with several meds and yoga and meditation when we finally get our regimens to a point where we can atleast take care of the bare minimum to survive its a huge blessing and throwing a wrench in someones treatment plan throws their lives in absolute upheaval for weeks months maybe years. We all have people that count on us too.  Nothing is going to magically fix the damage the lack of oversight has caused and taking the only treatment options we have when there is nothing to replace it with is just as irresponsible. So I dont know how you measure or quantify if something truly gives relief to someone that is ill but I can tell you this if they didnt give me relief from my illness I wouldnt take them as part of my treatment many antidepressants and neurological meds for chronic pain and illness like Lyrica have just as violent and as many side effects and you have to ween off of them because the body becomes physically dependent or addicted to them. Ive had to do this several times from several so called treatments. Not every treatment works for everyone so please lets leave this to the patients and their drs who have exhausted all the options and would love for new treatments to be available and are anxiously hoping they do but until that time I still have to be a functioning member of society. Thank you for your time I agree that those that abuse opioids and any other narcotic is making it next to impossible to get any narcotics prescribed if you have chronic pain or acute stress such as PTSD. I am 100% service connected total and permanent disabled and any narcotics that I was receiving and were helping me are being discontinued with no replacements of meds that do anything to help control my symptoms. Then when I was sent through the program to see a civilian doctor, they did two surgeries on me but would not prescribe any pain control because they said the VA wont let them and my VA doctors refused to prescribe any pain medication to me either because of the opioid crises. They consider every narcotic off limits if its an opioid or not and my urine is checked for any drugs every three months or more often. I am at the mercy of the  VA and the doctors have obviously been told to take everyone off narcotics and not to prescribe any. If a civilian doctor does write a prescription for me I have to get it rewritten by a VA doctor before I can get it filled and they wont rewrite them. Medical marijuana is legal in my state but they wont discuss its use or the use of CBD which is totally legal to use. Having to go civilian for care will make this problem even worse because of what I have stated. Also I received this email to comment on the changes to the VA on April 10th but it states that all comments had to be received by sometime in March. This seems like it will be a bad deal for us veterans just by the way I was contacted about it over a month after comments were being considered. I would appreciate a response to my statement and would like to include that I was a registered nurse in the USAF and civilian.