Purdue and Shionogi's new constipation approval goes up against AZ, Valeant rivals

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Purdue and Shionogi's Symproic won FDA approval Thursday.

AstraZeneca’s Movantik and Valeant’s Relistor have been battling it out in the opioid-induced constipation arena since winning their FDA approvals back in September 2014. Now there’s a third competitor prepping to jump into the mix.

Thursday, Japan’s Shionogi and Connecticut’s Purdue Pharma announced that U.S. regulators had greenlighted Symproic, the pair’s once-daily tablet for the malady. The partners intend to share marketing duty in the U.S., where they expect to launch mid-summer, they said in a statement.

Symproic will be coming from behind when it does hit the market, with its competitors having had more time to build their leads. But it also bears an addiction risk red flag from the Drug Enforcement Agency as a Schedule II controlled substance, a classification its makers are petitioning to get removed.

There’s a precedent for that in the OIC field, too. The agency descheduled Movantik less than a year after the med nabbed its regulatory go-ahead.

Purdue could use a boost from the new product, considering the beating its sales of highly addictive pain med Oxycontin have taken as U.S. officials have moved to address the opioid epidemic. The company has been maligned in lawsuits and by law enforcement officials and state and federal lawmakers alike, and to top it all off, it’s been struggling to fend off generic copycats, too.

Meanwhile, Valeant has been working to give Movantik a bigger challenge after raking in just $48 million in 2015 Relistor sales—a sign that the Canadian drugmaker and partner Progenics have quite a ways to go if they want to fulfill their blockbuster predictions. On that front, they snagged an FDA thumbs up last July for an oral formulation of the formerly subcutaneous-only drug, closing the convenience gap between Relistor and its rival.

Still, though Relistor and other struggling products in Valeant’s GI portfolio aren’t where the company hoped they’d be. While the company hasn’t broken down 2016 sales figures for Relistor specifically, late last year it pledged to ramp up the sales force behind the med—an effort that may have been thwarted by the arrival of another new constipation competitor. Movantik, for its part, pulled in $91 million for AZ in 2016, with $26 million coming in Q4.