Opioid crisis: First once-monthly injectable approved

Sublocade is the first and only once-monthly injectable buprenorphine formulation for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by dose adjustment for a minimum of seven days. Sublocade 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.

Sublocade is expected to be available to patients in the U.S. in Q1 2018. 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 one month period.

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. Sublocade contains buprenorphine, a partial agonist at the mu-opioid receptor. Mu-opioid receptors in the brain are known to mediate the subjective effects of opioids, including drug-liking, which is the pleasure associated with opioid use. Sublocade delivers sustained plasma levels of buprenorphine that translate into high mu-opioid receptor occupancy in the brain, which blocks the drug-liking effects of opioids.