FDA

FDA panel votes yes on Indivior’s opioid addiction drug

Indivior’s (LON: INDV) experimental drug to fight opioid addiction may soon get the green light from regulators following a near-unanimous vote for approval by an advisory committee.

The drug, called RBP-6000, is an injectable version of buprenorphine to treat opioid use disorder. The medicine is meant to be used as part of a treatment plan that includes counseling and psychosocial support.

Considering the growing opioid addition crisis in the US, the FDA’s advisory committee voted 18-1 that RBP-6000 could benefit addicts. Regulators usually follow the recommendations of these committees, and the FDA is due to decide on the drug by Nov. 30.

Max Herrmann

The good news is timely for Indivior, who’s anticipating some competition on its other revenue-driving drugs. In September the company warned investors that a US court ruling had “significantly increased” the risk of new competitors to its Suboxone Film treatment, a product that combines buprenorphine and naloxone and is placed under the tongue or inside the cheek. The recent court ruling cleared the way for a generic rival to the drug. 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.

An approval for RBP-6000 could mean significant new revenue for Indivior. 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.

Shares for Indivior, trading on the London Stock Exchange, are up 8.5% on the news Wednesday morning.


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