Is There a New Type of Buprenorphine Treatment for Opioid Addiction?

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In 2002, the Food and Drug Administration (FDA) approved a medication called buprenorphine that ushered in a new era of opioid addiction treatment, and now, close to 25 years later, and new type of buprenorphine treatment for opioid addiction is available, approved by the FDA in May 2023.

Addiction treatment experts from the National Institutes of Health (NIH) discuss the history and development of buprenorphine, and its relevance to us, today, as follows:

“The discovery of buprenorphine in 1966 revolutionized care for opioid use disorder. US government and private industry partnership led to buprenorphine-based medications. Confronting barriers to use these medications is critical to address the opioid crisis.”

Buprenorphine is a core component in an approach to opioid addiction treatment called harm reduction. It’s a primary medication used in medication-assisted treatment (MAT), which is considered the gold-standard treatment for opioid addiction, also known as opioid use disorder (OUD).

When the FDA approved buprenorphine, it joined another medication – methadone – approved for treating opioid use disorder. However, because of a higher risk of diversion for illicit use, federal restrictions around methadone made access difficult. In some cases, these rules prevented people who needed treatment from getting the treatment they needed. Upon approval, the federal government placed fewer restrictions around buprenorphine than around methadone for two reasons:

  1. It’s a partial opioid agonist, as opposed to a full opioid agonist – like methadone – which means it creates almost no euphoric effect, thereby decreasing risk of diversion.
  2. Pharmaceutical companies designed buprenorphine in specific formulations that precipitate withdrawal when altered from their original form and injected intravenously, i.e. diverted from as directed uses to illicit

Here’s how FDA commissioner, Dr. Robert Califf, describes the approval of this new buprenorphine treatment option, called Brixadi:

“Buprenorphine is an important treatment option for opioid use disorder. Today’s approval expands dosing options and provides people with opioid use disorder a greater opportunity to sustain long-term recovery.”

We’ll now discuss what’s new about Brixadi, and why it makes a difference for people seeking evidence -based treatment for opioid use disorder (OUD).

Reducing Barriers to Care: Harm Reduction and New Buprenorphine Treatment Option

Evidence shows medication-assisted treatment (MAT) with methadone, buprenorphine, and/or naltrexone can significantly improve treatment outcomes for people with opioid use disorder (OUD). People on MAT experience:

  • Decreased opioid use
  • Decreased overdose fatality
  • Increased time-in-treatment
  • Improved social and family function
  • Improved work and school function
  • Reduced relapse rates
  • Reduced criminal behavior

That’s why it’s called the gold standard treatment for OUD. It works better than anything else we know about. However, as we mention above, there’s risk of diversion for illicit purposes. That’s why both methadone and buprenorphine treatment are highly regulated, with rules around buprenorphine less restrictive than around methadone.

Before COVID, many of the rules around MAT involved who could prescribe and dispense medication, how treatment initiation could occur, how patients could access medication, and how often patients had to show up in person to either receive medication, engage in counseling and therapy, and submit samples for drug testing.

Because of the various public health measures adopted in 2020 to stop the spread of COVID, the federal government temporarily changed the rules so that at-risk patients with OUD could either initiate or continue MAT without increasing risk of contracting COVID. These new rules also protected health care workers from unnecessary exposure to COVID.

To learn about the changes instituted during 2020, please navigate to the blog section of our website and read this article:

The Mainstreaming Addiction Treatment (MAT) Act: Will We Keep COVID-Era Changes?

The new medication, Brixadi, addresses one of the most difficult problems to overcome, with regards to MAT: the balance between realistic expectations for what we require of people on MAT and the risk of diversion. Before COVID, rules restricted refills and the amount of medication a person could receive at a time. Here’s how Brixadi makes some of those rules obsolete.

Brixadi: New Buprenorphine Treatment for Opioid Addiction

  • It’s an extended-release medication, which reduces barriers to care by mitigating access problems such as:
    • Transportation to office visits
    • Getting time off work for office visits
    • Arranging childcare during office visits
  • Various weekly doses can accommodate the severity of the OUD, and help patients who don’t tolerate the higher doses of extended-release buprenorphine currently available. Weekly doses or Brixadi include:
    • 8 mg, 16 mg, 24 mg, and 32 mg
  • Various monthly doses also accommodate the severity of OUD and help patients who don’t tolerate high doses of extended-release buprenorphine currently available. Monthly doses of Brixadi include:
    • 64 mg, 96 mg, and 128 mg.

The weekly doses are designed to promote treatment adherence for people new to MAT who need a period of stability on the medication. The monthly doses are designed for people who are already stable on MAT, participating in treatment, and at lower risk of relapse, diversion, or other adverse events associated with MAT.

MAT, Counseling, Therapy, and Patient-Centered Treatment

Reducing barriers to care is a priority in the FDA Overdose Prevention Framework. One issue treatment professionals and regulatory officials have gone back and forth about is the role of counseling and therapy for patients on MAT.

To be clear, MAT is about more than medication. It’s about a whole-person approach to recovery that includes medication, therapy, counseling, and peer support. Counseling and therapy are required for participation in MAT. However, for some patients, two things make participating in counseling and therapy difficult for people on MAT:

  1. The in-person requirement for therapy sessions can prevent people without transportation from attending all sessions.
  2. Early in recovery, some patients are simply trying to get through the day, and are not in a physical, psychological, or emotional condition where participating in counseling or therapy would be beneficial or possible.

Previously, the inability to participate in therapy or counseling sessions was perceived as a requirement for initiating MAT. In a letter accompanying the approval or Brixadi, federal officials addressed this interpretation of the current regulations:

“This letter serves to clarify the importance of counseling and other services as part of a comprehensive treatment plan, but to also reiterate that the provision of medication should not be made contingent upon participation in such services.”

With regards to counseling and therapy, federal regulators indicate that assessing each individual to identify their current and accurate stage of change is what should determine participation in counseling and therapy, rather than a blanket, one-size-fits-all rule applied upon initiation of treatment.

Some patients are ready to engage in therapy and counseling immediately. Others are better served engaging in therapy and counseling after they make progress in treatment and achieve stability on their medication. These decisions should be the result of a shared decision-making process that includes the patient and the provider.

Treatment With MAT Saves Lives

It’s clear – as indicated in the letter above – that opioid use disorder is often accompanied by serious and complex psychological and social issues that medication cannot resolve on its own. That’s why it’s essential to offer these supports when appropriate, which means when they have the best chance of increasing overall treatment success.

At the same time, MAT – without concurrent therapy or counseling – reduces risk of relapse and reduces rates of fatal overdose.

In other words, it saves lives.

That’s why federal regulators clarified their stance. Evidence shows a combination of medication and therapy leads to the best possible overall outcomes. Evidence also shows that patients can benefit from buprenorphine treatment when counseling/therapy is not available right away. Therefore, in the words of the current Assistant Secretary for Mental Health and Substance Use at the Substance Abuse and Mental Health Services Administration (SAMHSA):

“OUD…treatment…can begin with stabilization on medication.”

That’s the guidance from the very top of our federal regulatory system. We think it’s entirely logical, and aligns with our vision of both harm reduction and integrated, person-first treatment.

The materials provided on the Pinnacle Blog are for information and educational purposes only. No behavioral health or any other professional services are provided through the Blog and the information obtained through the Blog is not a substitute for consultation with a qualified health professional. If you are in need of medical or behavioral health treatment, please contact a qualified health professional directly, and if you are in need of emergency help, please go to your nearest emergency room or dial 911.