Dear Valued Visitor,

We have noticed that you are using an ad blocker software.

Although advertisements on the web pages may degrade your experience, our business certainly depends on them and we can only keep providing you high-quality research based articles as long as we can display ads on our pages.

To view this article, you can disable your ad blocker and refresh this page or simply login.

We only allow registered users to use ad blockers. You can sign up for free by clicking here or you can login if you are already a member.

FDA Approves Trulance From Synergy Pharmaceuticals Inc (SGYP) To Battle With Allergan PLC (AGN) 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 Pharmaceuticals, Inc. (NASDAQ:IRWD)’s Linzess. Surprisingly, industry watchers are already predicting the likelihood of having the newcomer take lead on Linzess’ IBS-C territory.

In appreciation of the FDA’s act of confidence in Synergy Pharmaceuticals Inc (NASDAQ:SGYP), 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.”

pharmacist, medical, retail, worker, team, young, staff, lab, chemistry, business, drug, chemist, adult, teamwork, internet, male, drugstore, service,


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 Pharmaceuticals Inc (NASDAQ:SGYP) stock closed at $5.53 a fall of $0.23 or 3.99%.

Follow Synergy Pharmaceuticals Inc. (NASDAQ:SGYP)
Trade (NASDAQ:SGYP) Now!

Note: This article is written by Andy Parker and originally published at Market Exclusive.

DOWNLOAD FREE REPORT: Warren Buffett's Best Stock Picks

Let Warren Buffett, George Soros, Steve Cohen, and Daniel Loeb WORK FOR YOU.

If you want to beat the low cost index funds by 19 percentage points per year, look no further than our monthly newsletter.In this free report you can find an in-depth analysis of the performance of Warren Buffett's entire historical stock picks. We uncovered Warren Buffett's Best Stock Picks and a way to for Buffett to improve his returns by more than 4 percentage points per year.

Bonus Biotech Stock Pick: You can also find a detailed bonus biotech stock pick that we expect to return more than 50% within 12 months.
Subscribe me to Insider Monkey's Free Daily Newsletter
This is a FREE report from Insider Monkey. Credit Card is NOT required.