Pharmaceutical Compositions for the Treatment of Inner Ear Disorders

Abstract

The present invention provides compositions containing (i) a pharmaceutically active agent selected from a group consisting of an arylcycloalkyamine or a derivative, analogue or pharmaceutically active salt thereof, and (ii) a biocompatible polymer or a combination of biocompatible polymers. These compositions or medicaments containing these compositions may be used for the prevention and / or treatment of inner ear diseases, e.g. tinnitus.

Description

FIELD OF THE INVENTION[0001]The present invention relates to compositions of one or more pharmaceutical compounds for the prevention and / or treatment of tinnitus and other disorders of the inner ear.BACKGROUND OF THE INVENTION[0002]Various inner ear disorders, e.g. hearing loss, inner ear infectious disease or tinnitus, have attracted increased interest with the object to provide new therapies. E.g. tinnitus, the perception of sound without external acoustic stimulation, is a very common inner ear disorder. An estimated 7% to 14% of the population have talked with their physician about tinnitus, while potentially disabling tinnitus occurs in approximately 1% to 2.4% of people (Vesterarger V., British Medical Journal 314 (7082): 728-731 (1997)). Tinnitus is often associated with other hearing disorders, such as hearing loss or hyperacusis, i.e. hypersensitivity to sound (Sahley T. and Nodar R., Hearing Research (152): 43-54), and quite often originates in the inner ear.[0003]Various ...

AI Technical Summary

Benefits of technology

[0013]The composition of the present invention comprises a biocompatible polymer support incorporating a therapeutically effective amount of at least one pharmacologically active agent as defined above. The arylcycloalkylamine agent may e.g. suppress or reduce the perception of tinnitus. Preferably, the composition is formulated such that, upon delivery into the middle ear, it is capable of remaining in contact with at least one of the middle-inner ear interface tissue structures and providing extended release of the pharmacologically active agent into the inner ear. Preferably, the biocompatible polymer is biodegradable as well and may also increase the permeability of the target middle-inner ear interface tissue structure to enhance diffusion of the pharmacologically active agent.

Problems solved by technology

While some of them have shown great promise, none of them is in regular clinical use, yet.

One of the key obstacles to the development of effective treatments has been the fact that the inner ear is protected like the brain by a biological barrier.

For systemic drug administration, relatively high doses are usually required to achieve a desired therapeutic effect in the inner ear, carrying the risk of potent side effects on the central or peripheral nervous system.

This compares favourably to the administration of the pharmaceutical compound in a solution, where multiple injections might be required, drug percolation back into the ear canal or significant loss down the Eustachian tube could result, and continuous contact with the middle-inner ear interface tissue structure might be difficult or impossible to achieve.

However, there is less known about topical treatment of inner ear diseases with other formulations.

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