The US Food and Drug Administration has granted approval to Sublocade (buprenorphine extended release) for the treatment of patients with moderate to severe opioid use disorder. Shaun Thaxter, chief executive officer of Indivior, described the approval as an “important step forward for patients families and communities battling the opioid epidemic”. The drug is expected to be available in the United States in the first quarter of 2018. Shaun
A 2016 study by the American Society of Addiction Medicine found around two million Americans had a substance use disorder involving prescription pain relievers. Despite this, less than half of these are treated with medication-assisted treatment, according to the “Medication-Assisted Therapies - Tackling the Opioid Overdose Epidemic” report published in the New England Journal of Medicine.
A number of medication-assisted therapies are already available in the United States. These include medication to alleviate withdrawal symptoms such as methadone, and medication to block the effects of opioids, such as Suboxone (buprenorphine and naloxone) or Subutex (buprenorphine). Sublocade, which contains buprenorphine, falls into the latter category, and it is a partial agonist at the mu-opioid receptor.
Sublocade was approved following a phase III clinical trial in which patients were randomly put on one of three treatment programs, one of which was a placebo regimen. It found the two programs with Sublocade demonstrated greater efficacy in achieving illicit opioid-free weeks.
“In the Opioid Blockade Study, Sublocade achieved complete blockade of drug-liking effects for a full month in most patients… The urgency for this new treatment has never been greater, as the US opioid crisis has been declared a national public health emergency,” Thaxter stated.
The Indivior product is administered subcutaneously by a registered healthcare professional. It is the first and only once-monthly injectable formulation of buprenorphine developed to treat moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product.
Sublocade is not the first product developed to help with opioid addiction to gain FDA approval in recent weeks. Last month, the FDA approved the NSS-2 Bridge device, an electric stimulation device designed to help reduce the symptoms of opioid withdrawal.