The FDA has approved Sublocade, the first once-monthly injectable buprenorphine product for moderate-to-severe opioid use disorder (OUD) in patients who have initiated treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product.
The following language is extracted from the FDA’s press release for Sublocade:
Sublocade is indicated for patients that have been on a stable dose of buprenorphine treatment for a minimum of seven days. Sublocade can provide a new treatment option for patients recovering from OUD who may value the benefits of a once-monthly injection compared to other forms of buprenorphine, such as tablets, implants, or film that dissolves in the mouth, reducing the burden of medication adherence.
The drug is injected by a health care professional under the skin, forming a depot of buprenorphine that is released over time. Sublocade should not be administered intravenously, as the depot could cause blockage, tissue damage, or embolus, which can lead to death. In clinical trials, Sublocade provided sustained therapeutic plasma levels of buprenorphine over the one-month dosing interval. Common side effects include constipation, nausea, vomiting, headache, drowsiness, injection site pain, itching (pruritus) at the injection site and abnormal liver function tests.
Sublocade should be used as part of a complete treatment program that includes counseling and psychosocial support. Regular adherence to medication-assisted therapy (MAT) with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids.
For further information, read the FDA press release.