New analysis affirms risk/benefit profile of Synergy's Trulance in CIC; shares up 5%
Jun. 5, 2018 1:02 PM ET|By: Douglas W. House, SA News Editor
A new retrospective risk/benefit analysis from pooled Phase 3 trial data assessing Synergy Pharmaceuticals' (SGYP +4.7%) TRULANCE (plecanatide) and Allergan (AGN +0.8%) and Ironwood Pharmaceuticals' (IRWD -0.5%) LINZESS (linaclotide) in adult patients with chronic idiopathic constipation (CIC) showed the relative advantage of TRULANCE. The data were presented at Digestive Disease Week in Washington, DC.
A metric called "number needed to treat" or NNT, showing the number of patients that need to be treated to show a clinical benefit (low number is better), was comparable between TRULANCE 3 mg and LINZESS 72 mcg and 45 mcg.
Another metric called "number needed to harm" or NNH, showing the number of patients that need to be treated before seeing a detrimental effect (high number is better), favored TRULANCE. Its NNH value was almost 3x higher than its NNT values, implying that treated patients are three times more likely to experience a beneficial effect before experiencing a harmful effect.
The NNH values for LINZESS were lower than the NNT values implying that patients receiving either dose would most likely experience a harmful effect before experiencing a beneficial effect.
The FDA approved TRULANCE for CIC in January 2017.
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