Synergy's Trulance wins an OK to battle Allergan's Linzess in CIC—and IBS-C could be next

Synergy's Trulance will take on Allergan's Linzess in the chronic idiopathic constipation market after winning FDA approval this week.

There’s a new competitor to Allergan and Ironwood’s Linzess on the block in the chronic idiopathic constipation (CIC) market. And the way some industry watchers see it, it may not be long before the newcomer starts treading on Linzess’ IBS-C territory, too.

On Thursday, the FDA announced that it had approved Synergy’s Trulance to treat CIC in adults, with Julie Beitz, M.D., director of the Office of Drug Evaluation III, noting in a statement that “no one medication works for all patients suffering from chronic gastrointestinal disorders.”

In addition to putting some heat on Linzess, the regulatory go-ahead “paves the way for the eventual expansion of the label” to include IBS-C, Barclays analyst Geoff Meacham wrote in a note to clients. And if that happens, the two meds will be going head-to-head on both fronts.

Linzess, of course, has a substantial market lead; the FDA approved it for both indications back in 2012, and multiple DTC efforts have helped drum up U.S. sales that reached $452 million through the first nine months of 2016. And while “the rates of diarrhea for Trulance appeared to be improved vs. Linzess” in two phase 3 trials of Trulance in IBS-C, Meacham said, New York-based Synergy didn’t disclose the incidence of other major outcomes—including pain.

“Pain remains one of the most prominent symptoms of IBS-C (in contrast to CIC), and Linzess’ efficacy with regards to managing pain has been major contributor to its adoption and growth,” he wrote.

So while Meacham expects Trulance to snag its second regulatory green light later this year, “absent clear evidence of improved efficacy and tolerability in IBS-C, … we continue to see Linzess as the dominate player given its wide adoption, overall safety, and first mover advantage,” he said.

That’s good news for Allergan, whose top-line haul missed the mark in the third quarter, thanks, in part, to Namenda IR generics. In addition to older contributors like Linzess, though, Allergan's launches can help fill the gap, the company figures; it’s predicting combined peak sales of about $5 billion for 11 new products.