The FDA has approved a new treatment plan for a long-acting injection, making it easier for people with moderate to severe opioid use disorder (OUD) to begin and maintain their treatment. The updated protocol for the medication Sublocade allows patients to receive the injection after just one dose of buprenorphine, followed by a one-hour wait to ensure safety. This change enables a quicker start to treatment and provides more options for the injection site, including the stomach, thigh, buttock, or upper arm.
OUD is a chronic condition caused by the misuse of opioid painkillers, which significantly impacts a person’s physical, emotional, and mental well-being. It often develops when individuals take higher doses of opioids than prescribed, use them more frequently, or seek the euphoric effects of these drugs. The condition leads to physical dependence, emotional distress, and severe withdrawal symptoms when opioid use is reduced or stopped. Since opioids affect brain areas responsible for essential functions, OUD presents a serious health concern.
Sublocade is a long-acting injectable form of buprenorphine, a medication that helps manage opioid cravings and withdrawal symptoms. It works by partially activating opioid receptors while blocking the effects of stronger opioids. Initially approved in 2002, this once-monthly injection is administered under the skin, where it forms a gel that steadily releases buprenorphine throughout the month. This steady release helps prevent the fluctuations associated with daily opioid use. Sublocade is only available through a restricted program known as the SUBLOCADE REMS Program, which ensures that it is dispensed in certified healthcare settings and pharmacies.
A clinical study examined two methods of initiating treatment with a long-acting opioid use disorder injection in 729 participants who had used opioids for approximately 15 years. One group received the injection within an hour of taking a single dose of buprenorphine, while the other group waited seven days after taking daily doses. The study found that 66.4% of participants in the rapid-start group proceeded to receive a second injection, compared to 54.5% in the group that waited a week. These results suggest that starting treatment sooner may improve patient retention and adherence to the treatment plan.
Common side effects of Sublocade include constipation, nausea, headaches, fatigue, and localized pain or itching at the injection site. Some individuals may also experience elevated liver enzyme levels. Patients are advised not to use the injection intravenously, as this can be life-threatening. Before starting treatment, individuals should inform their healthcare provider about any history of addiction, breathing problems, liver conditions, or adrenal disorders. Additionally, patients should disclose any medications they are taking, particularly sedatives, as combining them with Sublocade can be dangerous.
Pregnant individuals or those planning pregnancy should consult with their doctor about potential risks, including the possibility of opioid withdrawal in newborns. Patients should also monitor the injection site for signs of complications such as redness, swelling, abscesses, sores, or tissue damage and report any unusual symptoms. It is important to consult a doctor before stopping Sublocade, as sudden discontinuation can lead to severe withdrawal symptoms.
