Rexahn: Holes Galore in Serdaxin Data
More from the Rexahn press release:
"The trial also validates the earlier results which demonstrated Serdaxin to be safe and well tolerated without the appearance of serious side effects that are commonly linked to currently marketed antidepressant drugs, such as selective serotonin uptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), and tricyclic antidepressants (TCA). Even though the overall study did not achieve statistical significance, we believe, based on the statistically significant subgroup results, Rexahn plans to commence a Phase IIb clinical trial in the second half this year."
Ah, so here's where Rexahn tells investors that the study failed overall. Now, I'm actually willing to cut Rexahn a little slack here. A study enrolling 77 patients across four treatment arms is probably not powered strongly enough to achieve statistical significance. However, that doesn't give the company license to data-mine the study and declare victory because some arbitrarily defined subgroup of a subgroup appears to have responded to the drug.
Moreover, Rexahn does a lousy job of disclosing the side effect profile of Serdaxin. All drugs have side effects, yet Rexahn tells us nothing except that patients didn't experience side effects commonly seen with other currently marketed anti-depressants.But what about side effects commonly seen in patients taking clavulanic acid, which is the active ingredient in Serdaxin? Clavulanic acid is an old drug and a component of the antibiotic Augmentin, used to overcome resistance to certain strains of bacteria.
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