(The Jan. 19 story corrects paragraph 9 to say Ironwood Pharma also sells Linzess in North America)
(Reuters) - The U.S. Food and Drug Administration said on Thursday it had approved Synergy Pharmaceuticals Inc's drug to treat chronic idiopathic constipation (CIC).
Synergy's once-daily tablet, Trulance, is the company's first to win regulatory clearance.
However, the safety and effectiveness of the drug have not been established in patients less than 18 years of age, the FDA said. (http://bit.ly/2k5wNlA)
The company's shares were marginally down at $6.40 in extended trading. The stock had gained about 28 percent in one month.
CIC, which affects 14 percent of the global population, is a type of gastrointestinal disorder where individuals have difficult and infrequent bowel movements. It is called idiopathic because the cause is unknown.
Trulance met the main goals of two late-stage studies in December on irritable bowel syndrome patients with constipation (IBS-C).
Synergy's Trulance, whose chemical name is plecanatide, is expected to generate peak sales of $348.8 million by 2021, according to Thomson Reuters Cortellis.
The drug is expected to compete against Ironwood Pharmaceuticals Inc's Linzess, which got approved in 2012 to treat IBS-C and CIC in the United States.
Linzess, which is sold by Allergan Plc and Ironwood in North America, AstraZeneca Plc in China, Hong Kong and Macau, Allergan in Europe and Astellas Pharma Inc in Japan, generated global sales of $464.7 million in the nine months ended Sept. 30.
(Reporting by Divya Grover, Dipika Jain and Komal Khettry in Bengaluru; Editing by Maju Samuel)