CPEX Pharmaceuticals, Inc. (CPEX)

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7:04AM CPEX Pharmaceuticals announces preliminary results from its Phase 2a clinical trial of Nasulin (CPEX) 15.75 : Co reported preliminary results related to its Phase 2a proof-of-concept clinical trial of the its nasal insulin product, Nasulin. The primary objective was to demonstrate that subjects receiving Nasulin would achieve a larger increase from baseline in the mean proportion of time spent with normal glucose levels (or in euglycemia) than those receiving placebo, as assessed by continuous glucose monitoring. Although subjects in the placebo group spent less time in euglycemia at the end of the study compared to subjects in the Nasulin group, the difference between the two groups was not statistically significant (p-value = 0.2). The secondary efficacy measurements of change from baseline in average glucose as measured by continuous glucose monitoring and the change from baseline in serum fructosamine were consistent with the primary endpoint analysis. No critical safety signals were detected with Nasulin in the study. The most common adverse events were those attributable to administration site reactions associated with the nasal route of delivery, the majority of which were mild.