FDA, New Products

Synergy bags an FDA OK for constipation therapy Trulance in the lead up to an sNDA

The FDA has handed Synergy Pharmaceuticals $SGYP an approval for plecanatide, which will now hit the market as Trulance for chronic idiopathic constipation.

The biotech, which has stoked rumors about a potential buyout in the recent past, posted some stellar data from a pair of Phase III clinical trials for CIC and now will see if it can give Ironwood a run for its money in offering a rival to Linzess.

“No one medication works for all patients suffering from chronic gastrointestinal disorders,” said Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition.”

Synergy did earn a red flag on a safety warning, as regulators signaled their concern about severe diarrhea experienced by some patients. The rate was tracked at 0.6% for Trulance, which was better than the 2% rate of severe diarrhea for Linzess. Linzess, though, has also posted a somewhat better efficacy profile which will offer considerable protection in the market showdown to come.

Synergy is already producing positive data for irritable bowel syndrome with constipation, a natural second category to go after for a drug like this. Trulance is a peptide therapy designed to replicate the function of uroguanylin, spurring fluid secretion and promoting stool consistency necessary to support normal bowel function.

The company is already planning a supplemental NDA for IBS with constipation.

Ardelyx, meanwhile, is also plugging along with tenapanor for IBS-C.

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