The FDA has given Indivior the OK to sell its monthly injectable version of Suboxone, shoring up the company’s tenuous hold on the opioid addiction market as competition looms near.
The drug, to be marketed as Sublocade (RBP-6000), is a monthly injection of buprenorphine, which contains a mild opioid to help stymie withdrawal for addicts quitting opioid use. The medicine is meant to be used as part of a treatment plan that includes counseling and psychosocial support.
The news doesn’t come as a surprise. Considering the growing addiction to opioid-based painkillers and heroin in the US, the FDA’s advisory committee made a strong recommendation to approve the drug earlier this month. And rivals will be well received at the FDA.
“Everyone who seeks treatment for opioid use disorder deserves the opportunity to be offered the treatment best suited to the needs of each individual patient, in combination with counseling and psychosocial support, as part of a comprehensive recovery plan,” said FDA Commissioner Scott Gottlieb. “As part of our ongoing work in supporting the treatment of those suffering from addiction to opioids, the FDA plans to issue guidance to expedite the development of new addiction treatment options. We’ll continue to pursue efforts to promote more widespread use of existing, safe and effective FDA-approved therapies to treat addiction.”
Indivior’s film version of this drug, which is dissolved under the tongue or inside the cheek, has been the market leader in this field for the past two decades. But the company’s grip on the market was compromised when generics and other competitors began to creep onto the scene. In September the company warned investors that a US court ruling that cleared the way for a generic rival had “significantly increased” the risk of new competitors. In a press release back in September, Indivior said it could lose up to 80% of its market share “within a matter of months” thanks to the new competition.
And then there’s Suboxone’s branded rival Vivitrol (made by Alkermes), which recently made its case for equal efficacy to Indivor’s drug. This monthly injection works differently than Suboxone, blocking the effect of opioids. Alkermes’ central branding message is that Vivitrol is cleaner, containing no opioids. But the drug also requires patients to be detoxed entirely from opioids, which can prove problematic for addicted patients.
Although not great news for competitors, this new approval for Indivior could mean significant revenue for the company. Max Herrmann, an analyst at Stifel, expects the drug could capture 30% of the broader buprenorphine market. He expects annual sales of about $700 million by 2021, while Jefferies analysts expect peak sales of $1.3 billion by 2025.
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