The Food and Drug Administration has approved an extended-release, subcutaneous injection formulation of buprenorphine for use in treating moderate to severe opioid use disorder (OUD), the manufacturer of the drug announced Nov. 30.
The new product, called Sublocade, is a monthly injection intended for use in patients who have already begun treatment of OUD with transmucosal buprenorphine products, followed by a dose adjustment for a minimum of 7 days. Sublocade contains the partial mu-opioid agonist buprenorphine. By administering a consistent level of buprenorphine into the body, it ensures that levels of buprenorphine are delivered to the mu-opioid receptors, diminishing the effects of opioids, including the euphoric sensations associated with opioid use. During the clinical trial program, buprenorphine plasma concentrations of 2-3 ng/mL were found to bind to greater than 70% of mu-opioid receptors.
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“In the Opioid Blockade Study, Sublocade achieved complete blockade of drug-liking effects for a full month in most patients. Sublocade is the first and only therapy that, at steady state, delivers buprenorphine at a sustained rate of at least 2 ng/mL over a 1-month period,” Shaun Thaxter, chief executive officer of the drug’s manufacturer, Indivior, said in a press release. “The urgency for this new treatment has never been greater, as the U.S. opioid crisis has been declared a national public health emergency. Sublocade’s approval is an important step forward for patients, families, and communities battling the opioid epidemic.”
According to a statement from the FDA, Sublocade will be distributed only to health care providers as part of a Risk Evaluation and Mitigation Strategy to ensure that the product is not distributed directly to patients. Sublocade should be administered only by a health care professional. Self-injection of Sublocade into the blood stream instead of subcutaneously could lead to occlusion of blood vessels and embolism, according to one of the drug’s boxed warnings. It also should be used as part of a complete treatment program that includes counseling and psychosocial support.
The FDA is also requiring the manufacturer to conduct postmarketing studies to assess which patients would benefit from a higher dosing regimen, to determine whether Sublocade 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, and to 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.
At recent joint meetings of the FDA’s Psychopharmacologic Drugs and Drug Safety and Risk Management advisory committees, panelists voted on Oct. 31 to recommend approval of Sublocade and on Nov. 1 for another subcutaneous buprenorphine injection formulation. These actions have not gone unnoticed by the American Medical Association.
“The AMA enthusiastically supports Food and Drug Administration Commissioner Scott Gottlieb’s efforts to advance policies and actions to treat those suffering from an opioid use disorder,” Patrice Harris, MD, immediate past chair of the American Medical Association Board of Trustees and a member of the AMA Opioid Task Force, said in a statement. “We also second his bold acknowledgment that criminal justice systems should offer [medication-assisted treatment] to those being detained. As he points out, ‘At the very moment when the criminal justice system could be dramatically lowering the risk of overdose, it is creating the conditions of reduced tolerance to opioids that substantially raises the risk of death upon release.’ With his clear explanation of the problem and solution, this situation can be remedied.”
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