Plecanatide is filed NDA at FDA to treat chronic idiopathic constipation (CIC)- Synergy Pharma

Synergy Pharmaceuticals Inc. has announced the company has filed with the FDA its first new drug application (NDA) for plecanatide in chronic idiopathic constipation (CIC). The plecanatide NDA for CIC is supported by positive results from two phase III clinical trials which Synergy completed in 2015. If approved, Synergy plans to launch plecanatide with the CIC indication in the first quarter of 2017.

Comment: Synergy will be competing with the first in the GC-C agonist class � Ironwood Pharmaceuticals and Forest Laboratories (now Allergan)' Linzess (linaclotide), which was approved in August 2012 as a once-daily treatment for IBS-C or CIC Barclays analysts pointed out in a research note, while the efficacy of Synergy's drug seems "marginally lower" than that of Linzess, plecanatide achieved a diarrhea rate of just 5%. Ironwood's treatment is labeled with warnings that roughly 16% of patients experience the side effect, and Barclays believes that could differentiate the drugs if they ever go head to head. Average discontinuation rates due to adverse events were about 5 percent for plecanatide, while it was 8 percent for Linzess.

Comment: A further competitor is Amitiza (lubiprostone) from Sucampo with annual sales of around $300 million, similar to those of Linzess.The low diarrhoea side effect of plecanatide was a most important results of its trials so far.