FDA approves first and only therapy of its kind for opioid addiction

pharmafile | December 1, 2017 | News story | Medical Communications, Sales and Marketing FDA, Invidior, Sublocade, US, opioid crisis, opioids, pharma 

Image Credit:  Marco Verch

As the US languishes in the midst of an opioid crisis which President Trump declared national emergency just weeks ago, the FDA has announced that the first and only once-monthly buprenorphine injection for the treatment of moderate-to-severe opioid use disorder, Indivior’s Sublocade, is now authorised for use 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 next year.

Matt Fellows

Related Content

GSK’s Ojjaara approved by FDA for patients with myelofibrosis and anaemia

GSK has announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) …

Madrigal Pharmaceuticals’ NDA for resmetirom accepted by FDA

Madrigal Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted for …

FDA approves LimFlow system for patients with CLTI

LimFlow SA has announced that the US Food and Drug Administration (FDA) has approved its …

Latest content