Auditory Loss and Deafness

October 24, 2011

Auris Medical issued results from a phase IIb trial of AM-101 for the treatment of acute inner ear tinnitus. This double blind, randomized, placebo-controlled, parallel dose group trial enrolled 248 subjects with persistent inner ear tinnitus following a documented acute acoustic trauma or sudden deafness incident less than three months before. The subjects received three intratympanic injections of either AM-101 at 0.27 or 0.81 mg/ml or placebo over three consecutive days. The primary endpoint was the change in the tinnitus minimum masking level from baseline to day 90. The subjects who received AM-101 at 0.81 mg/ml showed a statistically significant reduction in tinnitus loudness, sleep impact and the THI-12 questionnaire score (p<0.05 or <0.01). Local treatment with AM-101 was well tolerated, and had no negative impact on hearing.

October 3, 2011

Otonomy issued results from a phase Ib trial of OTO-104 for Meniere's disease. This randomized, placebo-controlled, multicenter study enrolled 44 subjects with unilateral Meniere's disease. The subjects received OTO-104 (3mg or 12mg) or placebo administered as a single intratympanic injection. During a one month baseline period, the subjects experienced an average of eight days with definitive vertigo episodes. Following a single intratympanic injection, subjects in the 12 mg OTO-104 group experienced a month-over-month reduction in vertigo frequency throughout the three month follow-up period, and achieved an approximate six day reduction in the number of definitive vertigo days in the third month versus baseline. When compared to placebo, the 12 mg study group experienced a 70% greater reduction from baseline in the number of days with definitive vertigo episodes. In addition, both the 3 mg and 12 mg OTO-104 doses were associated with improvement in tinnitus. This improvement was seen as early as one month following treatment and continued throughout the entire three month follow-up period.

June 26, 2006

Auris Medical issued positive results of a phase I/II trial of AM-111, for the treatment of acute sensorineural hearing loss (ASNHL). This open-label study enrolled 11 subjects experiencing ASNHL associated with acute acoustic trauma (>30 dB in worst affected ear, <20 dB in other ear) across 2 sites in Germany. Subjects received single 250 mcl transtympanic injections of either 2 mg/ml or 0.4 mg/ml concentrations of the drug in a gel formulation in their worst affected ear only, with follow-up at 30 days. Trial data indicated that the drug was well tolerated, with the majority of adverse events deemed unrelated or not likely related to treatment. Preliminary evidence of efficacy was also noted: subjects improved from a baseline hearing loss of 35.9 dB to 24.5dB at 30 days, compared to an improvement from 20.0 dB to 17.6 dB for the untreated ear.

Cortex Pharmaceuticals reported mixed results of a pair of phase II trials of CX717, for the treatment of poor cognitive performance due to night-shift-work sleep disruption, at the Sleep 2006 meeting in Salt Lake City. The first trial, a randomized, double-blind, placebo-controlled, parallel group study conducted in 50 healthy male volunteers over 4 nights at the Walter Reed Army Institute of Research, found no significant improvements in measures of cognitive performance, compared to placebo. In a separate study of the drug in a sleep-deprivation model conducted in the UK, preliminary data indicated that CX717 dose-dependently altered recovery sleep architecture, as measured by EEG polysomnography. The highest trial dose (1000 mg) significantly reduced the amount of slow wave sleep during each of four recovery sleep periods (p<0.05), and increased wake time after sleep onset during 2 of the 4 recovery sleep periods (p<0.05). The company indicated that differences in trial design may have contributed to the disparity between results, and additional data analysis was planned.