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Synergy Pharma's Trulance Gets FDA Approval, CEO 'Truly Thrilled'

Synergy Pharma's Trulance Gets FDA Approval, CEO 'Truly Thrilled'

The U.S. Food and Drug Administration said it approved Synergy Pharmaceuticals Inc's (NASDAQ: SGYP) plecanatide, branded as Trulance, for the treatment of chronic idiopathic constipation (CIC). This approval marks the company’s first.

Trulance is a one-tablet-a-day drug used to treat a form of gastrointestinal disorder that make patients have difficult and infrequent bowel movements. The drug is expected to generate peak sales of $348.8 million by 2021, Thomson Reuters has estimated.

Benzinga reached out to Synergy Pharma’s CEO, Gary Jacob, who provided this statement:

“We are truly thrilled with this approval because it provides an additional, much-needed, new treatment option to help adults with chronic idiopathic constipation and healthcare providers manage this condition.”

Synergy said it has plans to file a supplemental New Drug Application (NDA) for Trulance over the course of the current quarter seeking approval for the treatment of irritable bowel syndrome with constipation (IBS-C).

The stock initially fell over a $1 per share in the after-hours session and traded recently at $6.35, down about $0.06 from the close.


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