More than three years after it was raised from the dead, Otonomy’s lead drug appears headed to the scrap heap for good.
The drug, Otividex, failed to beat placebo at reducing definitive vertigo days for the intent-to-treat population of patients with Ménière’s disease. The p-value, at 0.312, was a far cry from statistical significance.
Despite definitive flops in earlier trials, execs had insisted they had a shot after a second Phase III — which they had originally said they would drop — apparently backed up their belief that they could mine positive data if they focused on the average number of vertigo days at month 3. And that’s not the only tweak they would make to the trial: Back in July, they went to the FDA with a revised statistical analysis plan using a “negative binomial model.”
It didn’t help. The trial enrolled 148 patients who have Ménière’s disease — a condition