Significant Barriers Remain for People Needing Long-Acting Buprenorphine

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SublocadeTM, the long-acting, once a month injection of buprenorphine to treat opioid use disorder, is still very difficult to obtain for patients who could benefit from it. There are significant use-case examples where SublocadeTM injections would be more beneficial to certain patients than regular oral buprenorphine. These cases include people who are unsure about their housing situations in the future, as buprenorphine is a medication that needs to be safe and secure and away from children. Also, people who tend to forget to take medication or tend to misplace medications would greatly benefit from a once per month injection received at a doctor’s office. With many people out there who could benefit from SublocadeTM, and with SublocadeTM being on the market since 2017, one might think that many patients were already enjoying the benefits of this medication in 2020. Apparently, that is not the case. A study published in the North Carolina Medical Journal found significant barriers blocking patients from using the medication, and the barriers are difficult to understand for anyone not familiar with the way medication-assisted treatment is done in the United States. 

The authors also make a good point regarding Suboxone therapy in general. Many patients have unwanted side-effects when taking medication that includes Naloxone, a short-acting drug that is only included with buprenorphine to stop “abuse” of the drug. The brand name Suboxone does include naloxone. Many patients have claimed that medications which include naloxone cause more unwanted side effects than buprenorphine on its own. Subutex is the brand name of buprenorphine without any added naloxone, and some patients prefer to take Subutex. The authors make the point that SublocadeTM, the long-acting buprenorphine injection, is also naloxone-free, and therefore would work for patients who want to avoid taking naloxone. This is how the authors sum up the multiple-use scenarios for SublocadeTM, 

“A 30-day injectable form of buprenorphine branded as SublocadeTM (Buprenorphine XR SQ) was approved by the FDA in 2017. This medication is administered by a health care professional subcutaneously in the abdomen to treat opioid use disorder. This long-acting delivery system holds great promise for many patients who have barriers to taking daily transmucosal buprenorphine-containing medications such as those with poor adherence to daily medication. It is beneficial for those who have difficulty safely storing their medications, including patients who have children in the home, unstable housing, or live with others who have a use disorder. This product is also an option for patients who prefer mono-product buprenorphine. As Buprenorphine XR SQ is administered directly by a healthcare professional, it does not contain the abuse-deterrent naloxone that some patients feel causes side effects.”

However, the researchers themselves found SublocadeTM incredibly difficult for patients to begin taking. There are only two ways to get SublocadeTM, and both include jumping through hoops that no normal patient could put up with. They involve working with specialty pharmacies, getting special approval from government bodies, and other non-standard activities for patients to undertake if they want to begin a SublocadeTM regimen. The authors eventually were able to craft a system where patients could sign up via the manufacturer’s web portal and go forward from there, but it all seems incredibly unlikely in the context of the current treatment system. Florida Springs Wellness and Recovery is one of the licensed practitioners of medication-assisted treatment in Florida, so I have seen the current system and how it functions. Buprenorphine and Methadone therapy in Florida is a highly regulated process. Buprenorphine and Methadone therapy practitioners in Florida usually choose one medication or the other, as regulations make it difficult to add new medications to an existing process. Florida Springs is a trusted MAT provider in Florida, and they use Subutex, which is a buprenorphine medication that does not include naloxone. As stated above, some patients prefer medications that do not include naloxone. Outpatient methadone rehab in Florida is mostly performed at sanctioned clinics, and many people believe that the capacity at these clinics should be expanded to include more patients in the future. Florida Springs has had success with the use of Subutex rather than methadone for outpatient medication rehab for opioid use disorder, but both methadone and Subutex have shown effectiveness over the course of many professional medical studies. 

SublocadeTM could be an important offering for certain patient types, and it is disappointing that the barriers to the treatment described in this article remain in place. Hopefully, this study from the North Carolina Medical Journal shines a needed light on the makers of SublocadeTM and the regulators in charge of long-acting injectable buprenorphine treatment. 

By T.A. Cannon (Contact me at TACannonWriting@gmail.com)

 

References

MAJOR, E. et al. Long-acting, Injectable Buprenorphine: Great Promise, but Significant Barriers to Use. North Carolina medical journal, [s. l.], v. 81, n. 3, p. 210–211, 2020. DOI 10.18043/ncm.81.3.210. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&db=mnh&AN=32366637&authtype=geo&geocustid=s8475741&site=ehost-live&scope=site. Acesso em: 10 dez. 2020.