A new form of a widely used opioid addiction treatment that is injected monthly instead of taken daily as a tablet was approved Thursday by the Food and Drug Administration. Experts say the eagerly anticipated new version of the drug may help patients reduce relapses, disrupt the treatment market, and possibly dispel misconceptions about the drug’s potential for abuse.
Indivior is the first company to gain approval for a monthly injection of buprenorphine. The company is best known for Suboxone, a daily formulation that combines buprenorphine with naloxone into a film that dissolves under the tongue.
“It’s potentially a game changer,” said Dr. Andrew Kolodny, co-director of opioid policy research at Brandeis University. “This could become first-line [medication] for opioid addiction. It could open up opportunities for getting more patients on buprenorphine.”
The new product, known as Sublocade, was one of two long-acting buprenorphine injectable products before the FDA. Approval for Indivior’s drug was anticipated after an advisory panel voted 18 to 1 to recommend it in October. A decision on a similar medication made by Braeburn Pharmaceuticals is expected early next year.
FDA Commissioner Scott Gottlieb said that Sublocade was “part of our ongoing work in supporting the treatment of those suffering from addiction to opioids.” The approval of the long-acting buprenorphine was in line with the FDA’s plans to “issue guidance to expedite the development of new addiction treatment options,” he said a statement.
“We’ll continue to pursue efforts to promote more widespread use of existing, safe and effective FDA-approved therapies to treat addiction,” Gottlieb added.
The FDA noted that Sublocade’s approval followed two clinical studies — including a randomized controlled clinical trial and an open-label clinical trial — of 848 adults who had been diagnosed with moderate-to-severe opioid-use disorder and had started taking Suboxone first. The results of the studies found that patients who were treated with Sublocade had “more weeks without positive urine tests or self-reports of opioid use” than those who administered a placebo.
The findings also showed that a higher proportion of patients on Sublocade had “no evidence of illicit opioid use throughout the treatment period,” the FDA said in a statement. The agency noted the most common side effects of Sublocade included constipation, nausea, and vomiting.
Patients who get Sublocade will receive an abdominal injection administered by a health professional after starting a daily regimen of sublingual buprenorphine tablets for at least seven days. If approved, Braeburn’s long-acting product, CAM 2038, would be available as either a weekly or a monthly shot, and would not require these stabilizing doses of daily buprenorphine.
Both long-acting products differ from Alkermes’s Vivitrol, the leading brand of injectable extended-release naltrexone, because neither one requires a detox period before patients can receive their first injection.
Providing more options for patients to take buprenorphine, Kolodny said, will make them better positioned to benefit from the drug and more likely to feel “well and normal” compared to naltrexone.
“Buprenorphine gives a stimulation of the opioid receptors, and that means better control of cravings without experiencing subclinical withdrawal,” he said.
As the nation’s opioid crisis worsens — an estimated 50,000 people died of opioid overdoses in 2016 — spending on medicine to treat opioid-use disorder has skyrocketed, with Medicaid-covered prescriptions more than doubling between 2011 and 2016.
In terms of market share for those drugs, Medicaid spending last year on buprenorphine prescriptions was five times higher than naltrexone, the only monthly injectable available to patients seeking treatment for opioid use disorder. The approval of long-acting buprenorphine could diminish one of the biggest competitive advantages held by Vivitrol, which was approved in 2010 to treat opioid use disorder.
While a major study found that both treatments had comparable effectiveness, it also concluded that patients had a harder time getting started on Vivitrol because they needed to be fully detoxed first. Some experts believe long-acting buprenorphine could dramatically influence addiction treatment across the country.
“This new technology has the potential to greatly influence the way patients are treated today,” Mike Derkacz, CEO and president of Braeburn, told STAT. “[It can] free patients from the daily decision and reminder of the disease.”
Long-acting buprenorphine could also make further inroads within the criminal justice system. In recent years judges, wardens, and health officials have warmed up to Vivitrol, citing fears that daily tablets of buprenorphine can be diverted or abused.
The risk of abuse has prompted physicians and officials — including former U.S. Health Secretary Tom Price — to downplay its effectiveness by saying buprenorphine “substitutes” one opioid for another.
“In the criminal justice setting, they’ve been very reluctant to provide [daily doses of] buprenorphine in prisons,” Dr. Nora Volkow, director of the National Institute of Drug Abuse, said in a recent STAT interview. “The question now is how will they respond to [the fact that] extended-release buprenorphine cannot be diverted.”
Dr. Chinazo Cunningham, associate chief of general internal medicine at Montefiore Medical Center, says she’s “skeptical” that this particular formulation “is going to be the answer” to widening the use of buprenorphine. She said that providers need more training to overcome the current lack of education in treating opioid use disorder.
“There’s still a tremendous amount of stigma among patients and in communities about taking any opioid agonist in treatment,” Cunningham said. “I hope that a reduction in potential diversion [from long-acting buprenorphine] may get more providers to offer buprenorphine [of all kinds]. The more options the better, so we can match treatment to patients’ needs.”
Derkacz of Braeburn told STAT that the company expects a decision from the FDA on its long-acting CAM 2038 by January 19, 2018.