FDA Statement: Efforts to Promote Effective Treatment (and a new Buprenorphine)

 

The Food and Drug Administration (FDA) is a federal executive branch of American government. It is responsible for the protection and promotion of public health by controlling and supervising, among many other things, all pharmaceutical drugs, whether prescription or over the counter. Because of the ongoing opioid crisis, which many blame in part on the over-prescribing of legal opioids, the FDA has faced a wealth of criticism. On November 30th of this year, FDA Commissioner Dr. Scott Gottlieb issued a statement regarding the FDA’s plans on how to “promote more widespread innovation and access to opioid addiction treatments,” as the title of the statement explains.

The statement also announces the new FDA approval of an improved version of buprenorphine, a drug commonly used to treat opioid addiction but also used to treat chronic pain.

This article analyzes Dr. Gottlieb’s statement, looks further into some of the claims made, and summarizes the new formulation of buprenorphine. We’ll begin with this new formulation and go from there. We try to remain neutral regarding who is to blame for the opioid crisis that kills about one hundred Americans every day. We care only about how to end it, and how to prevent it from ever happening again. It’s those aspects of the FDA statement we focus on.

Buprenorphine (Subcolade)

Prior to 11/30/17, buprenorphine was administered to recovering opioid addicts one of three ways: a tablet, a dissolvable film, or an implant. The tablets and/or films must be taken daily, and the implant can be both expensive and invasive. On 11/30, Subcolade was approved by the FDA, which is a once-monthly injectable buprenorphine medication. This means major positive changes for recovering opioid addicts utilizing a buprenorphine-based recovery method. Subcolade should be widely available by March of 2018.

Subcolade involves time-release buprenorphine, which is indeed an opioid itself. Reducing the number of monthly opioid intakes from thirty to one should prove incredibly beneficial. Shaun Thaxter, CEO of Indivior, the pharmaceutical company that will issue the new drug, said, “Subcolade is a scientific innovation that represents a new treatment option to help patients attain more illicit opioid-free weeks during their treatment program.”

Using opioid-based medication to fight an opioid addiction might seem at first like fighting fire with fire, but it’s proven the best method for recovery. This is because the body and brain of an opioid addict are extremely altered, and removing the presence of opioids suddenly can cause bodily system failures on top of some potentially wretched withdrawal effects. Therefore, using opioid-based medication under a medically supervised watch, also known as medication-assisted treatment, or MAT, is the safest and most effective method of recovery.

In fact, November’s FDA statement explains how there are only three FDA-approved medications used to combat opioid addiction. They consist of buprenorphine, which we just covered, as well as methadone and naltrexone.

Methadone & Naltrexone

By far the oldest of the three, methadone was first synthesized in the 1930s. Although it poses perhaps the most risks of the medications, methadone may also be the most effective. Detox using it can be quickened, to as short as less than a month, or prolonged, to as long as six months. This makes methadone rather useful regarding personally curated recovery. Side effects include all of those associated with illicit opioids, and in some cases the addiction to a patient’s drug of choice becomes replaced by an addiction to methadone.

Naltrexone, commonly marketed as Vivitrol, is unique because it can be used as treatment for opioid addiction, but also for alcoholism. Another unique factor about naltrexone is that patients do not begin doses until fully detoxified from their drug(s) of choice. Effects begin within a half an hour, but decreased desire for opioids could take up to a month.

We wanted to give you an overview of the three FDA-approved medications for combating opioid dependence before explaining how in the statement, Dr. Gottlieb claims: All three of these treatments have been demonstrated to be safe and effective in combination with counseling and psychosocial support. Everyone who seeks treatment for an opioid use disorder should be offered access to all three options. This allows providers to work with patients to select the treatment best suited to a patient’s individual needs.”

The FDA’s Plans

It’s very clear that Dr. Gottlieb and the FDA want to expand access to treatment, especially to MAT. According to the 2013 National Survey on Drug Use and Health, not even 11% of substance addicts in America received the treatment needed for them to become healthy again. The flipside of this tells us that approximately 9 out of every 10 addicts are receiving zero assistance to fight their disease. In the statement, Dr. Gottlieb explains how President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis found that MAT (again, medication-assisted treatment), “has been associated with reduced overdose deaths, retention of persons in treatment, decreased heroin use, reduced relapse, and prevention of the spread of infectious disease.”

Less overdose deaths, less drug abuse, more treatment, less relapse after treatment, and less diseases stemming from drug abuse would all be made possible if only more than 10.9% of America’s addicts were to receive MAT. Surely realizing this, Dr. Gottlieb’s statement makes it clear that the FDA plans on expanding access to MAT – even going so far as to try something completely new… (See next section.)

In more professional words, the statement claims that the FDA needs to do more than simply approve pharmaceuticals in light of the opioid epidemic which is largely fueled by such pharmaceuticals. So, the administration has a few plans…

Two guidance documents will be created. One will outline the FDA’s current approval guidelines for buprenorphine. The second will add to the first, using tactics that will “…facilitate the development of better treatments.” As part of these guidance documents, two ‘new principles’ will be implemented.

The first involves ‘modeling and simulation techniques’ that hopefully will prove the efficacy of the new time-release version of buprenorphine recently FDA-approved. The second will “…provide a framework for the development of novel clinical endpoints that can form the basis of product approvals.” A clinical endpoint in the context of drug addiction is essentially a symptom of withdrawal, some of which can be measured and some of which cannot be, such as craving. It is actually craving that the statement uses as an example, claiming that the FDA will attempt to “…develop a validated measurement of ‘craving’ or ‘urge to use’ illicit opioids to complement other endpoints and to determine how it supports the goal of sustained abstinence.”

Something New

In addition to all of this, the statement includes three plans for making MAT more available, the first of which is brand new to the FDA. Before we explain the plans, it’s important to recognize why nine out of ten addicts are not getting the help they need. It’s not because all addicts simply refuse, although surely some do. There exists a ‘treatment gap,’ as Dr. Gottlieb puts it, mainly because of insurance coverages. Most addicts either do not qualify for MAT, or find it “…prohibitively difficult to access FDA-approved addiction medications.”

So what’s the brand new idea from the FDA? The answer is research and meetings of experts that could “…lead to additional label indications that could, in turn, help support more widespread insurance coverage.” It’s amazing how a large part of the reason addicts aren’t getting treatment could be due to a war of words between health insurance companies and product labels. Hopefully some label adjustments will lead to a smaller treatment gap. Kudos to the administration for breaking the mold and venturing into an area in the war on drugs most of us wouldn’t ever think of venturing into.

That’s the first of three plans to narrow the gap. The second involves more direct modification of product labeling, and isn’t just limited to new or upcoming drugs. The FDA will re-evaluate all labels on all available forms of all medications used in MAT. That’s kind of a big deal. The assessment and modification of labeling for all types of Cheerios would likely be a huge undertaking. Now imagine doing it for pharmaceuticals. The FDA wants to make sure “…the current labels on the approved treatments to make sure they reflect the available science.”

The third offered plan is humble, is just, is necessary, but may also simply be an uphill climb. The statement refers to an ‘unfortunate stigma’ that surrounds the use of MAT. Sure, it can probably be difficult sometimes to convince a heroin addict working on recovery that another opioid is the answer. However, research-based methods are the only way to go. There exists no other way to discover what works other than research. Still, even in the face of facts, there are many, addicts and non-addicts alike, who believe MAT is simply replacing one drug with another. The FDA statement explains how patients may become physically dependent on medications used in MAT, but that they are not addicted:

Addiction requires the continued use of opioids despite harmful consequences on someone’s life. Addiction involves a psychological preoccupation to obtain and use opioids above and beyond a physical dependence. But someone who is physically dependent on opioids as a result of the treatment of pain but who is not craving the drugs is not addicted.”

Safety in Numbers

Let’s say nothing works. Let’s say labels stay the same and a year from now, still only one out of ten addicts are receiving the necessary help. One surefire agent of positive change is/will be the approval of injectable buprenorphine. There is safety in numbers, and as Dt. Gottlieb puts it, “The approval today [of injectable buprenorphine] is one step toward more options for the treatment of those addicted to opioids.” As the FDA continues to research and approve more and more forms of medications, logic says that more and more patients will receive the medications.

The final paragraph of the statement explains how through all of the above-mentioned methods, the FDA is taking a more active role than ever in fighting the good fight against opioid addiction. In so many words, Dr. Gottlieb said that prior to now, the administration existed in the background of the battle. Between a new form of MAT, the promotion of MAT, and the clinical testing processes involved in creating more proof that MAT works, it’s safe to say the Food and Drug Administration has joined the front lines.