FDA Approves Trulance from Synergy Pharmaceuticals Inc (NASDAQ:SGYP) To Battle With Allergan Linzess

The chronic idiopathic constipation (CIC) market has a new entrant. This was occasioned by the FDA’s approval of Trulance from Synergy Pharmaceuticals Inc (NASDAQ:SGYP). The agency’s move triggers stiff competition in a market dominated by Allergan plc (NYSE:AGN) and Ironwood’s Linzess. Surprisingly, industry watchers are already predicting the likelihood of having the newcomer take lead on Linzess’ IBS-C territory.

Story continues below

In appreciation of the FDA’s act of confidence in Synergy, the company’s chairman and CEO Gary S. Jacob said, “We are thrilled with the approval of Trulance because it provides an additional, much-needed, new treatment option to help adults with chronic idiopathic constipation and their healthcare providers manage this condition.”

Trulance was evaluated in the largest Phase III CIC clinical trials ever

Approval of any drug by the FDA calls for evaluation of its efficacy and safety. The evaluation of Trulance involved more than 2,600 patients in 2 randomized studies. The exercise was carried through over 12 weeks whereby placebo and Trulance were administered. The outcome for those who were treated with Trulance had a significant efficacy responder rate unlike those who used placebo. The description of an efficacy responder was 3 complete spontaneous bowel movements (CSBMs) within a single week.

An integrated analysis revealed that with diarrhea being the common adverse reaction, the users of Trulance had progressed as compared to placebo in stool frequency.

Trulance expects to snag its second regulatory green light later this year

Clear evidence of improved efficacy and tolerability will work to the advantage of Trulance. It is the first drug that has been designed to imitate the function of uroguanylin. While at this and despite the competition, IBS-C, Barclays analyst Geoff Meacham says that Trulance is eyeing a second regulatory approval later in the year.

Nonetheless, Linzess continues to be the biggest market player, thanks to its wide adoption, overall safety, and the fact that it is a first mover. There is no single medication that can work for all those suffering from chronic gastrointestinal disorders. However, the availability of optional therapies will help doctors administer the most appropriate treatment for different stages of the condition.

Meanwhile, Synergy stock closed at $5.53 a fall of $0.23 or 3.99%.

An ad to help with our costs