AstraZeneca PLC (NYSE:AZN) and Valeant Pharmaceuticals Intl, Inc. (NYSE:VRX) have been battling it out in the opioid-induced constipation arena with "movantik" and "relistor", respectively,  since winning their FDA approvals back in September 2014. Now there’s a third competitor prepping to jump into the mix.

Written by Carly Helfand (FiercePharma.com)

Thursday, Japan’s Shionogi (SGIOF) 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.

Said John Keller, President and Chief Executive Officer, Shionogi Inc.:

“The FDA approval of Symproic provides a safe and effective therapy for adult patients suffering from chronic non-cancer pain and struggling with opioid-induced constipation. We believe Symproic will offer a new therapeutic option to help reduce the needless suffering for those who experience OIC. The launch of Symproic with Purdue Pharma this summer will mark yet another milestone in our commitment to protect the health and well-being of patients we serve.”

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 de-scheduled "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 "xycontin" 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.

Said Mark Timney, President and Chief Executive Officer, Purdue Pharma L.P:

“By entering this exciting new therapeutic area with Shionogi Inc., we have the opportunity to further help patients with chronic non-cancer pain by offering more comprehensive care to both patients and doctors. The approval of Symproic marks a significant advancement in our partnership with Shionogi as well as the diversification of our product portfolio.”

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...