JB004/A

JB004/A is a selective prostaglandin analogue that has been shown to improve hearing and reduce tinnitus as well as vertigo in patients suffering from Ménière’s disease in two double-blind, placebo-controlled, phase II clinical trials performed in Sweden. The result of these trials is considered as proof of pharmacological concept in man. Although the two first studies have been performed in patients suffering from Ménière’s disease it is regarded likely that the beneficial effect may also be valid for patients suffering from tinnitus unrelated to Ménière’s disease. In the next trials the optimal concentration and formulation of the drug will be studied. Worldwide patents applications have been filed.

Ménière’s disease is a condition in which the inner ear is afflicted leading to episodes of vertigo, and hearing impairment as well as tinnitus. The prevalence of the disease is around 0.1 % of the population. The disease is chronic and usually unilateral. Currently there is no proven adequate treatment for the disease other than destructive therapy, either by ototoxic drugs or surgery, frequently leading to significant irreversible hearing loss. The prevalence figure for chronic severe tinnitus, unrelated to Ménière’s disease, e.g. in USA has been reported to be 2%. Currently there is no proven drug or surgical therapy for tinnitus.