Injectable Buprenorphine Sublocade Gets FDA Nod, Black Box Warning for Opioid Use Disorder


The approval marks the start of an agency effort to facilitate approvals of medication assisted treatment.

In its latest effort in the fight against the nationwide opioid epidemic, the US Food and Drug Administration (FDA) has approved Indivior Pharmaceuticals’ sublocade, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product.

The treatment contains a boxed warning against intravenous self-administration. According to an FDA statement, “If the product were to be administered intravenously rather than subcutaneously, the solid mass could cause occlusion (blockage), tissue damage or embolus (solid material that is carried in the blood and can become lodged in a blood vessel, which can lead do death).”

The statement continues, “sublocade must be prescribed and dispensed as part of a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the product is not distributed directly to patients.”

The treatment will be issued to health care providers via a restricted program, and can only be administered in a health care setting. Providers that administer the treatment will be required to complete an enrollment form attesting that they have procedures in place to ensure that Sublocade is dispensed only to health care providers and not directly to patients.

Buprenorphine for the treatment of opioid use disorder is currently approved for administration as a tablet, film, or implant. Sublocade provides a new treatment option for patients in recovery who may prefer a once-monthly injection that reduces the burden of taking daily medication as prescribed.

“Given the scale of the opioid crisis, with millions of Americans already affected, the FDA is committed to expanding access to treatments that can help people pursue lives of sobriety. Everyone who seeks treatment for opioid use disorder deserves the opportunity to be offered the treatment best suited to the needs of each individual patient, in combination with counseling and psychosocial support, as part of a comprehensive recovery plan,” said FDA Commissioner Scott Gottlieb, MD.

The FDA granted Indivior’s new drug application (NDA) for sublocade priority review and fast track designations. The agency is requiring postmarketing studies to assess which patients should benefit from a higher dosing regimen, to determine whether the treatment can be safely initiated without a dose stabilization period of sublingual buprenorphine, to assess the feasibility of administering sublocade at a longer inter-dose interval than once-monthly. Postmarketing studies will also determine a process for transitioning patients with long-term stability on a transmucosal buprenorphine dose to a monthly dose of sublocade without the use of a higher dose for the first 2 months of treatment.

Moments after the FDA announced sublocade’s approval, Gottlieb issued a statement regarding the FDA’s “critical part in the use of medications for opioid addiction treatment…through its role in the approval of new drugs.”

“Given the scope of the epidemic, we believe our efforts should go beyond the approval of these treatments. We believe that in light of the agency’s public health mandate, and the gravity of this crisis, the FDA also should encourage wider, appropriate use of these safe and effective medications. The agency is committed to taking new steps to advance each of these efforts,” Gottlieb wrote.

In the statement, the commissioner announced the issuance of 2 documents — one that details the agency’s current guidelines for the approval of depot formulations of buprenorphine for opioid dependence, and another that expands on those guidelines, and describes how to establish additional endpoints that may help facilitate the development of better treatments.

As part of the guidance documents, Gottlieb said the agency intends to expand 2 additional principles that can make pathways for developing medication-assisted treatment (MAT) more efficient.

These principles will create framework for:

  • Linking exposure levels to the safety and benefit of new, longer-acting formulations for existing drugs
  • The development of novel clinical endpoints that can form the basis of product approvals

The agency also intends to seek out research that can lead to additional label indications that would support more widespread insurance coverage and increased access to approved MATs, and destigmatize these products.

In closing, Gottlieb remarked that the approval of sublocade “is one step toward more options for the treatment of those addicted to opioids. The FDA is committed to taking steps to limit exposure to prescription opioids through measures to make sure prescribing is appropriate and carefully reflects evidenced-based clinical considerations.”

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