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Indivior drug to fight opioid addiction approved by US FDA

Dec 01, 2017

(Reuters) Indivior’s experimental drug to help fight America’s growing opioid addiction crisis was approved by the U.S. Food and Drug Administration late on Thursday, boosting its sales prospects as competitors threaten revenues from an older product.

Shares in the London-listed company, which specializes in addiction treatment, were up 10.9 percent at 411 pence at 0818 GMT on Friday. The stock was the top gainer on the FTSE Midcap index.

“We believe this decision is key for Indivior’s investment case ... A decent label and price should also help support near-term sentiment and a re-rating of the shares,” said Jefferies analysts, who rate the stock as “buy.”

The approval comes after an advisory committee to the FDA voted 18-1 that Indivior’s injectable drug could benefit addicts. Sublocade is expected to be available to patients in the U.S. in the first quarter of 2018.

“We are encouraged by this approval and ... we expect the story to shift more and more towards Sublocade as it grows,” Morgan Stanley analysts said.

United States is battling an opioid abuse epidemic that killed 33,000 people in 2015. President Donald Trump recently declared the problem a national public health emergency.

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