FDA approves first once-monthly injection for opioid abuse

December 5, 2017

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).

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.

Related: FDA clears first opioid withdrawal device

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.

Related: Activists: drugmakers, distributors liable for opioids abuse

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.

Read more: FDA advisors recommend 2 opioid use disorder drugs