The AudioNotch Tinnitus Treatment Blog

Please note: the following information does not constitute professional medical advice, and is provided for general informational purposes only. Please speak to your doctor if you have tinnitus.

The Swiss biopharmaceutical company Auris Medical is in the process of conducting the third clinical phase of trials on a medication created to alleviate inner ear tinnitus symptoms. Tinnitus refers to the various noises that patients hear in their ears or head after suffering traumatic cochlear injuries or severe otitis media, which is the medical term for middle ear infections. Statistics indicate that approximately 20 percent of the population in the United States lives with the problem. For some, the symptoms are so severe that the noise interferes with sleep and can disrupt a person’s overall quality of life. There is currently no medication to treat tinnitus.

About Auris Medical AM101

AM-101 is manufactured using the anesthetic Esketamine hydrochloride. The compound is designed to be biologically compatible and contained within a biodegradable gel. Esketamine hydrochloride acts as an N-Methyl-D-Aspartate or NMDA receptor antagonist. When the inner ear suffers trauma, sensory cells become damaged or die and the NMDA receptors in the cochlea become overactive. Researchers believe that this combination of actions lead to abnormal firing of the auditory nerves, which people hear as tinnitus. Auris Medial AM101 blocks the receptor sites, which in turns prevents the transmission of the abnormal nerve signals to the brain.

The treatment regimen requires that the medication be administered into the middle ear via injection through the ear drum. Patients receive a local anesthetic prior to each injection. Three injections are needed three to five days apart for effective symptomatic relief. Once injected, the medication spreads through the oval window and into the cochlea. If approved by the FDA, patients may receive treatment on an outpatient basis by a licensed ear, nose and throat physician.

Clinical Trial Results

The first two phases of the Auris Medical AM101 clinical studies were performed simultaneously in Europe and North America. During the first trial, patients diagnosed with tinnitus received three 0.81 milliliter doses of AM-101. The participants reported a gradual diminishing of symptoms. Three months after treatment, 48 percent of the volunteers reported improvement. Substantial improvement was experienced in 62 percent of the test subjects.

Adverse Reactions

Current Auris Medical AM101 trial studies indicate that patients tolerate the treatment well and do not suffer hearing or balance side effects from the injection or the presence of the medication. Esketamine is a derivative of the known anesthetic Ketamine. However, Esketamine more effectively inhibits NMDA receptors. The dose needed to treat tinnitus is also significantly lower than the dose required for anesthesia, which minimizes adverse reactions.