First and only medicine of its kind for opioid use disorder approved by FDA

As President Trump declared national emergency that the US languishes in the middle of an opioid crisis just weeks ago, the FDA has approved the first and only therapy of its kind for the treatment of moderate-to-severe opioid use disorder, the once-monthly buprenorphine injection, Indivior’s Sublocade can now be applied in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by dose adjustment for a week minimum.

Sublocade is a partial agonist of the mu-opioid receptor in the brain – the receptor which mediates the effects of opioids including the pleasure derived from their use – and works by delivering sustained plasma levels of buprenorphine which leads to high occupancy of the receptor in the brain, blocking the pleasurable effects of opioids.  

In a 12-week clinical trial, Sublocade was shown to fully block the pleasurable effects of hydromorphone, a potent opioid pain medication. In addition, the drug was found to be superior to placebo in achieving more illicit opioid-free weeks over 24 weeks total.

"Sublocade is a scientific innovation that represents a new treatment option to help patients attain more illicit opioid-free weeks during their treatment program," explained Shaun Thaxter, Chief Executive Officer of Indivior. "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 US 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."

Dr Brent Boyett, Clinical Investigator of Sublocade and Director at Boyett Health Services, also remarked: "Every patient’s journey to recovery is different and they face many challenges. To help support these differences, doctors and patients need options for medication-assisted treatment. In a Phase 3 clinical study, Sublocade helped patients refrain from illicit opioids for more weeks compared to placebo. Used in combination with counselling and psychosocial support, Sublocade is a transformational new drug that offers a treatment option for people with moderate to severe opioid use disorder."

The drug is expected to be available to US patients at the start of 2018.