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However, in the exenatide treatment group, the primary outcome rate was 61.2% (n=170), compared to 56.7% in the standard treatment group (n=171), with an adjusted ratio of 1.22 [95% CI, 0.79-1.88] (P=0.38)., which meant that the proportion of subjects who achieved the desired effect in exenatide treatment group was higher (110)

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In its Complete Response Letter (CRL), the FDA cited undisclosed product quality and master filing issues for the infusion device, which is proprietary to the device manufacturer, according to Supernus announcement