Once-Monthly Opioid Addiction Injection Cleared for U.S. Sales

(Bloomberg) -- Efforts to combat the opioid epidemic killing thousands of Americans each year got a boost from U.S. regulators with the approval of a first-of-its-kind monthly treatment for addiction to opiates including pills and heroin.

The treatment, Indivior Plc's Sublocade, is an injection of buprenorphine, a drug that lessens withdraw symptoms in addicted patients. Its infrequent dosing, once a month, could help patients better adhere to the regimen compared with existing versions that come in dissolvable tablets or films, the Food and Drug Administration said.

Approving new buprenorphine products is part of the the FDA's effort to destigmatize drugs to treat opioid addiction. Buprenorphine is itself an opioid, and critics have pushed back against its use, favoring an approach aimed at changing behavior. The approach the FDA is championing, called medication-assisted treatment, includes drugs alongside counseling to address the crisis, which President Donald Trump declared a public health emergency in October.

“Given the scale of the opioid crisis, with millions of Americans already affected, the FDA is committed to expanding access to treatments that can help people pursue lives of sobriety,” FDA Commissioner Scott Gottlieb said a statement late Thursday.

‘Urgency'

Sublocade will be available to patients early next year, Indivior said. The treatment is expected to generate $542 million in sales in 2020, based on three analysts' estimates compiled by Bloomberg.

Shares of the Slough, U.K.-based drugmaker rose 4.3 percent to 386.40 pence at 3:53 p.m. in London on Friday, after climbing as much as 13 percent.

More than 64,000 Americans died last year from overdosing on opioids, which include both legal and illegal drugs such as heroin, fentanyl and OxyContin, according to the National Institute on Drug Abuse. Patients who receive medication-assisted treatment cut in half their risk of death from all causes, according to the FDA.

“The urgency for this new treatment has never been greater, as the U.S. opioid crisis has been declared a national public health emergency,” Indivior Chief Executive Officer Shaun Thaxter, said in a statement. “Sublocade's approval is an important step forward for patients, families and communities battling the opioid epidemic.”

The FDA is working on guidelines that would help get more treatments for opioid addiction to market faster, Gottlieb said.

Sublocade was studied in patients who first began treatment with a buprenorphine film dissolved under the tongue and the amount they took was considered to be stable. The drug is supposed to be given by a physician and carries a warning about the risk of self-administration. The most common side effects included constipation, nausea, vomiting and headache.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net.

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Cecile Daurat, Timothy Annett

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