Soon after FDA approved a novel device to treat opioid use disorder, FDA approved the first and only once-monthly injectable buprenorphine formulation to treat moderate to severe opioid use disorder (OUD).
FDA granted the approval of buprenorphine extended-release injection for subcutaneous use (CIII) (Sublocade) to Indivior PLC.
In mid-November, FDA also granted a new indication to the NSS-2 Bridge device (Innovative Health Solutions), a small electrical nerve stimulator placed behind the patient’s ear, which can help reduce the symptoms of withdrawal from the prescription pain drugs.
Meanwhile, Sublocade—available to patients in the US in the first quarter of 2018—is intended to be administered only by healthcare providers and should be used as part of a complete treatment program that includes counseling and psychosocial support, according to Indivior.
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 one-month period, Shaun Thaxter, CEO of Indivior, said in a statement.
“Sublocade is a scientific innovation that represents a new treatment option to help patients attain more illicit opioid-free weeks during their treatment program,” Thaxter said. “The urgency for this new treatment has never been greater, as the U.S. opioid crisis has been declared a national public health emergency.”
In the Opioid Blockade Study, Sublocade achieved complete blockade of drug-liking effects for a full month in most patients. In a 12-week trial evaluating the blocking effect, Sublocade 300 mg fully blocked the drug-liking effects of hydromorphone.
Healthcare settings and pharmacies that order and dispense Sublocade must be certified in the Sublocade REMS Program.