The U.S. Patent and Trademark Office has granted Synergy Pharmaceuticals Inc (NASDAQ:SGYP) three new patents for its constipation drug, Trulance. One of the patents covers Trulance’s manufacturing method and its expiry date will be 15 years. Two other patents have to do with the formulation of Trulance and the method the drug uses to treat irritable bowel syndrome that is accompanied by constipation as well as chronic idiopathic constipation. The expiry date of these two patents will be on September 15, 2031.
“We are very pleased these additional patents were allowed and issued as they are a significant addition to the TRULANCE patent portfolio, providing extended exclusivity protection for TRULANCE,” Synergy Pharmaceuticals’ chairman and CEO, Gary Jacob, said.
Chronic idiopathic constipation
Taken as a tablet once a day, Trulance has received the approval of the U.S. Food and Drug Administration as a treatment for adult patients suffering from chronic idiopathic constipation. It is currently undergoing evaluation as a treatment for adult patients suffering from irritable bowel syndrome that is accompanied by constipation. This follows the submission of an sNDA – supplemental New Drug Application in late March.
Marketing of Trulance in the United States as a drug for adult patients suffering from chronic idiopathic constipation began a few weeks ago. The dosage that is recommended for such patients is 3 mg which is supposed to be consumed orally once a day. This can be at any time and can be accompanied by food or no food at all.
Not for children
Trulance is not recommended for patients who are under six years of age since it has been known to have fatal consequences as a result of its dehydrative effects. Additionally, the efficacy and the safety of the drug has not been established in patients who are above six years of age but who are under 18 years.
The dehydrative effects of the drug primarily arise from diarrhea. In the clinical trials involving adult patients, diarrhea is also listed as a common adverse reaction as it was observed in approximately 0.6% of the trial participants.
On Wednesday shares of Synergy Pharmaceuticals rose by 2.04% to close the day at $4.50.
