Little more than two weeks after commencing a European phase III trial of AM-101 in patients with acute peripheral tinnitus, Auris Medical AG has now begun a North American phase III study of the drug. Results from the two trials are expected next year, and, if positive, they could form the basis of regulatory submissions on either side of the Atlantic during the first quarter of 2016.
The North American study has already recruited the first of 330 patients with acute tinnitus in the inner ear due to trauma to the cochlea or due to otitis media (an infection of the middle ear). The double-blind, placebo-controlled trial is limiting enrollment to patients within three months of onset.
The European study is recruiting almost twice that figure – 600 patients in all – as it will examine the drug’s safety and efficacy in both the acute setting and the post-acute setting, defined as between four and 12 months after the onset of tinnitus. Patients