Study Reveals Tinnitus Treatment is Safe and Effective
Editor: Anyone who suffers from severe tinnitus has probably spent time looking for tinnitus treatment or a tinnitus cure. I think it’s still safe to say that there’s no cure for tinnitus, but it seem to be an increasing number of promising tinnitus treatments. One is AM-101 from Auris Medical, which has recently been shown to be safe and well tolerated, and to be effective in reducing tinnitus symptoms. Here’s the press release.
Key results from Auris Medical’s phase IIb study with AM-101, a novel intratympanic (i.t.) treatment for acute inner ear tinnitus, were presented at the recent 6th International TRI Tinnitus Conference in Bruges, Belgium. The study demonstrated that the treatment was well tolerated and safe and showed a statistically significant reduction in various tinnitus measures as compared to placebo. The outcomes were presented by Prof. Paul van de Heyning, head of the Department of Otorhinolaryngology at Antwerp University Hospital and one of the coordinating investigators of the study.
The double-blind, randomized, placebo-controlled, parallel-dose phase IIb study with AM-101 was conducted in Germany, Belgium, Poland and the Netherlands, involving almost 30 sites. A total of 248 patients suffering from persistent acute inner ear tinnitus were randomized to receive 3 i.t. injections of either AM-101 at 0.27 or 0.81 mg/ml or placebo over 3 consecutive days. Their tinnitus had to be triggered by acute acoustic trauma, sudden deafness (idiopathic sudden sensorineural hearing loss, ISSNHL) or otitis media and to be no older than 3 months. The clinical trial evaluated the safety and local tolerance of AM-101 and various efficacy outcomes. Study participants were monitored over 90 days.
The safety assessment of AM-101 in the phase IIb study showed no drug-related impact on hearing function. Anticipated adverse events related to the procedure of i.t. injection were of transient nature and occurred in moderate to low numbers. In terms of efficacy, the study demonstrated a dose-dependent improvement in various measures of the tinnitus symptom and its impact. Patients suffering from acute tinnitus with established cochlear origin (i.e. after noise trauma or otitis media) who received AM-101 at 0.81 mg/ml showed a statistically significant improvement (p <0.05 or <0.01) in tinnitus loudness, annoyance as well as tinnitus-related sleep difficulties and activity and participation limitations (TBF-12 questionnaire). In most cases the treatment effect started to appear within a few days from administration and continued to increase over the follow-up period. At Day 90, average reductions from baseline levels exceeded 50% for subjective loudness, annoyance and sleep difficulties and close to 50% for the TBF-12 score. Effects were somewhat less pronounced in patients with bilateral rather than unilateral tinnitus since only one ear was treated in the study as a precautionary safety measure. Efficacy outcomes with patients suffering from tinnitus related to ISSNHL were not conclusive for that subgroup overall, owing to an unexpectedly large rate of spontaneous recovery.
“The outcomes from the phase IIb study established proof of concept for AM-101’s efficacy in the treatment of acute inner ear tinnitus,” stated Prof. van de Heyning. “The robust and clinically meaningful improvements observed both for tinnitus loudness and patient-perceived tinnitus impact, as well as the good acceptance and tolerance of the treatment by patients, appear very promising.” Based on the positive outcomes from the phase IIb study, Auris Medical is moving ahead with the clinical development of AM-101, and is currently in discussion with regulatory agencies on the design for the planned phase III studies. “The phase IIb trial confirmed the importance of a targeted approach to tinnitus treatment, given the many different aspects of this bothersome symptom,” stated Thomas Meyer, Auris Medical’s founder and Managing Director. He added: “The trial provided us with a wealth of data and insights into AM-101’s therapeutic benefits and safety, which together with the outcomes from the currently ongoing TACTT1 study and the input from regulatory agencies will be essential for the appropriate design of the confirmatory phase III studies and the path towards marketing approval.”
More detailed information on the phase IIb clinical trial will be published in a scientific journal.
Source: Auris Medical