Requests that the FDA revoke orphan drug designation for Sublocade (buprenorphine extended-release) injection for treatment of opiate addiction in opiate users, currently referred to as opioid use disorder
revoke orphan drug designation for Sublocade (buprenorphine extended-release) injection for treatment of opiate addiction in opiate users, currently referred to as opioid use disorder OPEN Goodwin Procter LLP Braeburn, Inc. Citizen Petition CDER
2019-05-09 2019-05-14 2019-05-03 2019-04-15 2019-04-17 2019-04-16 2019-05-09 2019-05-09 2019-05-30 2019-05-01
FDA-2019-P-1679-0046 FDA-2019-P-1679-0048 FDA-2019-P-1679-0040 FDA-2019-P-1679-0028 FDA-2019-P-1679-0031 FDA-2019-P-1679-0030 FDA-2019-P-1679-0043 FDA-2019-P-1679-0047 FDA-2019-P-1679-0054 FDA-2019-P-1679-0036
04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0046 https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0048 https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0040 https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0028 https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0031 https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0030 https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0043 https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0047 https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0054 https://api.regulations.gov/v4/comments/FDA-2019-P-1679-0036
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Andrea G. Barthwell, M.D.  D.F.A.S.A.M. I know firsthand the devastation of the Opioid Addiction crisis. My husband and son have struggled with addiction for many years. My nonprofit organization Maryland Heroin Awareness Advocates (MHAA) is requesting the FDA to please strip the orphan designation granted to Sublocade. Every individual is different and no single treatment will work for all of them. The more available treatment options we have will save lives, and are necessary to curb the massive deaths from opioid intoxication. This is definitely not a rare disease, and too many people who suffer dont have access to quality, long term treatment. We need to bring more medically  assisted treatments to market  not keeping treatments that have been found to be safe and effective off the market. The FDA needs to be on the side of patients and bring more treatments to the market.The FDA should strip Sublocade of its orphan designation and ensure that more needed treatments are available to help stem this crisis. Medication assisted therapy is proven to be effective for patients in abstaining from use and remaining in treatment programs as well as reducing their risk of overdose. Our options are currently limited and restrictive, as they dont provide many opportunities for patients with less than perfect adherence. Just as we have seen with injectable antipsychotic medication, removing the variable of adherence for such an important disease state keeps people healthy longer. Compared to schizophrenia, this often means saving lives for patients with opioid use disorder. The classic definition of an orphan drug does not apply to this product and we need access to as many tools as possible to help these patients. Allowing another medication option will only give us more versatility to treat all patients in a way that works best for them.  A medication such as buprenorphine cannot he considered an orphan drug when it  is being used as the principle medication to treat a disease that has been declared a public health crisis. The FDA has stated that they are invested in making it easier for new treatments to be made available for the treatment of opioid use disorder however their actions show otherwise. As a treatment provider who sees the damage this disease causes to individuals and their families, I see the urgent need to have every life saving treatment made available today and not in 7 years from now. I write in my capacity as Professor of Psychiatry at NYU School of Medicine and as a NIDA-funded researcher focused on clinical trials for OUD.  In the midst of an opioid crisis that affects several million people directly, plus family, friends, communities, there is a compelling need for a broad range of treatment options, and there seems to be no justification for orphan drug status, nor orphan disease exclusivity, neither on the basis of the size of the population, nor on the size of the market, nor exclusivity on the basis of similarity.  People need all of the pharmacotherapy options available, including various formulations (and durations of action) of buprenorphine, extended release naltrexone, methadone, etc.  CAM2038, an alternative long-acting form of buprenorphine, differs substantially from Sublocade insofar as it can be initiated without a 7-day sublingual run-in period, making it the only long-acting opioid treatment that can be initiated directly in emergency departments (critical settings in which to intervene and save lives), and it does not contain NMP which precludes Sublocade use in pregnancy.   The opioid epidemic is taking lives in my community and impacting many people that I love. Granting orphan drug exclusivity will limit the treatments available to those who need them most. This makes no sense whatsoever. Right now, we need MORE treatments on the market, NOT less. Please reverse this terrible decision immediately. I am the Director and Founder of No More ODs, Inc. a Savannah Harm Reduction Coalition. We train and equip first responders, schools, restaurant staff, individuals or anyone that may come into contact with someone at risk of an opiate overdose, on how to identify an opiate overdose and how to reverse it.   After a life is saved, it is imperative to have resources available in order for the person to be able to live a healthy life of recovery. We need to be able to give options and choices to find the right fit for their Opioid Use Disorder. I lost my son, Austin, to an opiate overdose 14 years ago.  He didnt have the options available for a medically treated recovery.   Granting orphan exclusivity to Sublocade would block other, needed treatments from being available to patients who need more options.  Please do not grant orphan exclusivity to Sublocade, and please revoke its orphan drug designation. We need to ensure that patients can access to all safe and effective medications. Hello.  I am writing in reference to the petition being filed by Goodwin Procter against the FDAs decision to grant Sublocade orphan drug status.  As a dual board certified Addiction Specialist and Family Medicine Physician, I work as a Regional Medical Director for CleanSlate Centers.  We provide treatment to 13,000 patients in 11 states with OUD every day.  I have personally had more than 15 years prescribing buprenorphine products.On 1/10/18, Governor Wolf rightly declared the opioid epidemic an official statewide disaster in my home state of Pennsylvania following President Trumps declaration in October of 2017.  Pennsylvania had 5559 opioid overdose related deaths in 2017.  This is an all hands on deck disaster that demands every tool in the shed to be available for our patients. I very much appreciate the benefit that buprenorphine related medications have brought to the table in treating this epidemic.  I strongly believe that buprenorphine is directly accountable for countless lives saved during this crisis.  I regularly see patients go from hopelessness to holding down a job and resurrecting their families in a matter of months or even weeks when they go through our program.However, I firmly believe that as Alan Leshner, the former director of NIDA declared All treatment works for some patients.  No one treatment works for all patients.  On the frontlines treating this epidemic, it is vital that we are given as many tools as possible.  Indiviors product is a good product; however, it falls short in many instances.  Having a product that is only injected once a week and indicated for induction in addition to maintenance in the treatment of OUD is invaluable.  I strongly urge you to please revoke the orphan drug status for Sublocade and allow other innovative people to continue to supply the medical world with much needed tools.   I write this comment in my capacity as a former Governor of New Jersey and as the Chairman of President Trumps Commission on Drug Addiction and the Opioid Crisis.During my time as Governor I declared the opioid crisis a public health emergency and passed package of bills that expanded access to treatment and reduced opioid prescriptions by over 26% in its first year. I know that one of the keys to dealing with the crisis of losing 72,000 Americans a year is to make more medication assisted treatment available to more people in the throes of addiction.The FDAs decision to deny access to a buprenorphine depot injection treatment is against public policy and contrary to one of the specific recommendations of President Trumps Commission which I chaired. As an aside, the President himself has adopted that recommendation and 64 others from his Commission.The reason for the decision is even more wrong headed--an illogical application of the Orphan Drug designation and resulting exclusivity. This is a decision that must be revisited to further add to the medical communitys arsenal to deal with this deadly addiction crisis.The Orphan Drug Act was enacted to encourage research and development of treatments that may otherwise go undiscovered. Buprenorphine is in no way, shape or form an orphan drug. There are millions of American suffering from addiction who could benefit from additional therapies to deal with their disease. This action by the FDA is contrary to that laudable and necessary goal of the Commission and, just as importantly, contrary to the intent of the law as enacted. The exclusivity decision was meant to compensate for an otherwise unprofitable drug. Quite to the contrary, Sublocade is projected to be extremely profitable.This 1994 decision is no longer consistent with public health needs of 2019. The FDA must look at the needs of millions of Americans and make more treatments, not fewer, available to those in need. The FDA actions are not consistent with Administration policy. The FDA actions are contrary to implementing effective public health policy for this country. The FDA designation of Sublocade as an orphan drug is contrary to the law as passed and injurious to the public it is supposed to serve.I urge the FDA to rescind this decision and to make more treatments available to those who suffer from the disease of addiction. As a former Governor and Chairman of the Presidents Commission on this very topic, I have spent a great deal of time studying this issue in detail. I am convinced that rescinding this will save lives. Isnt that one of the key missions of the FDA? I hope that is true on behalf of millions of families from New Jersey and across America who are suffering today and frantically searching for hope.Respectfully,Chris Christie55th Governor of New JerseyChairman, Presidents Commission on Drug Addiction and the Opioid Crisis  While both CAM 2038 and Sublocade are both injections for the extended delivery of buprenorphine in the treatment of OUD, there are many differences between the two.  With these differences, come several unique advantages and disadvantages found in each.  Flexibility between weekly and monthly preparation, as well as a shorter run-in period, are just two examples of considerations when CAM 2038 may offer an advantage over Sublocade to better meet the needs of a certain cohort of OUD patient.It is important that doctors and patients have many treatment options in the battle against this public health emergency.  There is no one size fits all treatment for the complex disease of opioid use disorder and the doctor will need many tools in the toolkit. Buprenorphine is a very effective treatment molecule in the treatment of OUD.  Demand for access to OBOT care has soared over the past 10 years in many areas, outpacing our healthcare systems ability to provide this care.  With the rapid growth in demand for buprenorphine, it seems inconceivable to me that it could be considered for orphan drug status by the FDA, regardless of the delivery system. I strongly recommend that the orphan drug status for Sublocade be reconsidered to allow doctors and patients the option between these two effective, but different, treatments.