Expert: FDA Approves Buprenorphine Injections Label Change, Accelerating Access to Opioid Use Disorder Treatment

In an interview with Pharmacy Times®, Ann Wheeler, vice president of medical affairs at Indivior discusses the FDA approved label change for buprenorphine extended-release (Sublocade; Indivior PLC) that allows for rapid initiation of long-acting buprenorphine treatment within 1-hour of first dose, reducing the previous 7-day waiting period. Wheeler shares that this change aims to accelerate patient access to treatment, potentially reducing the risk of disengagement and relapse during a critical recovery period. The new label provides more flexible administration options, including additional injection sites and the ability to give a second injection as early as day 8. Wheeler emphasizes Indivior’s role in supporting health care providers with comprehensive educational resources to ensure smooth implementation of these new treatment protocols.

Pharmacy Times

How does the FDA's recent Sublocade label change directly address the critical window following an opioid overdose?

Ann Wheeler

The recent approval of the Sublocade label change enables the rapid initiation of a monthly, long-acting buprenorphine treatment. Previously, patients were required to be on a buprenorphine product for 7 days prior to starting Sublocade. Now, treatment with a monthly long-acting buprenorphine injectable can start on 1 one within an hour of a single dose of transmucosal buprenorphine. This potentially improves critical access to treatment and provides the opportunity to meet the patient where they are when they're ready to access care. In addition, the updated label gives providers the ability to give a second injection as early as day 8, which might help patients achieve and maintain therapeutic plasma level sooner, potentially improving treatment retention.

Pharmacy Times

What are the key advantages of administering long-acting buprenorphine within an hour, compared to the previous waiting period?

Wheeler

Administering long-acting buprenorphine within an hour rather than the previous required 7-day induction of buprenorphine offers a number of key advantages. So, it accelerates access to treatment, which reduces the risk of patients disengaging and then potentially relapsing during a very critical time period after they seek care from a provider for their opioid use disorder (OUD), and it potentially improves patients’ flexibility and then ultimately their treatment adherence or retention.

Pharmacy Times

How significantly will this FDA decision impact relapse rates among opioid use disorder patients?

Wheeler

At this point, it's a little too early to know how the label changes are going to impact relapse rates or other patient outcomes at this time. However, we do believe that administering long-acting buprenorphine within an hour, rather than requiring a 7-day period where patients have to be inducted on buprenorphine, can accelerate access to treatment, reducing the risk of patients leaving care and keeping them in care is what's critical in order to have treatment retention and ultimately recovery.

Pharmacy Times

Beyond immediate stabilization, how does the month-long delivery of Sublocade contribute to sustained recovery?

Wheeler

I think that that's a really important question to ask, and I'm really glad that you include that, because it's our goal to support patients during the recovery journey. Having recovery as an outcome, rather than anything else as a marker, I think, is critically important. So, by providing a monthly formulation Sublocade, reduces the burden of daily medication management, which can help patients stay engaged in their recovery journey. The recent label changes further improve treatment accessibility by allowing more flexible administration options for both the provider and the patient. That includes both having the second dose occur sooner, as well as having more injection sites available to the provider and the patient, potentially improving the flexibility, the choice that the patient has, as well as potentially treatment adherence.

Pharmacy Times

What role does this FDA action play in shifting the broader approach to the opioid crisis, particularly in terms of treatment versus enforcement?

Wheeler

While I can't speak to the role that the FDA should play in the opioid crisis, we're definitely pleased that the FDA approved these label changes that we believe can provide very important benefits for both patients and health care providers. At Indivior, we believe that every OUD patient should have access to treatment and have the opportunity for recovery, and we're dedicated to evolving our treatment options to better serve individuals who are struggling with opioid use disorder. Our label enhancements not only reflect our commitment to patient centered care but also reflect our ongoing efforts to align our treatments with real world clinical needs, thereby potentially improving patient retention and improving patient outcome.

Pharmacy Times

What logistical or practical challenges might arise in implementing this rapid-initiation protocol?

Wheeler

Indivior is committed to making sure that there's a seamless experience for both our partners as well as our patients. Following the label changes, we wanted to make sure that providers are educated very broadly and very quickly and compliantly about the key benefits on how to prescribe Sublocade with a new label, with a new dosing, the new indication, the changes that we've now have for Sublocade. We're committed to providing comprehensive educational resources, and we're offering updated and ongoing training sessions, webinars, materials to ensure that health care providers and pharmacists are well versed in the new label and the administration of Sublocade at the new injection sites. This includes guidance on injection site selection, different injection techniques for subcutaneous injection, monitoring patients post administration of Sublocade. We're also working to prepare all of our channel providers and partners on logistics that are associated with the acquisition and delivery of two injections that happen potentially close together. The first on day 1, the second, potentially as soon as day 8, but definitely by day 30 in the first month, in order to ensure that our partner programs deliver a seamless experience for our patients.

Pharmacy Times

How can pharmacists support patients through the critical transition to long-term recovery?

Wheeler

Again, a wonderful question to ask, because pharmacists play a key role in supporting patients, whether it be from the administration, to the injection itself, medication therapy management — you name it. Pharmacists play a very integral role in the treatment of patients with OUD. These label changes aim to enhance patient treatment experience and adherence, making it more accessible for patients with OUD who might struggle with adherence, right? We also believe these label updates are going to provide our health care providers with more options in initiating Sublocade treatment and providing alternative sites where they can inject Sublocade on the patient, potentially increasing the likelihood of successful long term treatment outcome. We would encourage all health care providers, including pharmacists, to consider the new options to better tailor treatment for individual patient circumstances and help them along their journey of recovery.

Pharmacy Times

Is there anything you would like to add?

Wheeler

The one thing that the label update also provides, in addition to a rapid initiation protocol for administration of Sublocade. It also does offer new sites of injection, which I think is very important, particularly for pharmacists who might be involved in administration of Sublocade. In addition to being available as a subcutaneous injection in the abdomen, we now have additional sites that can be used on day 1. So that would be the back of the upper arm, the thigh, as well as the buttocks. So, all those sites of injection can be used day 1, and this adds and enhances dosing flexibility in patient choice.