Description

LidoPAIN® TV is a topical lidocaine patch applied to the periauricular skin region (behind the ear) for the treatment of tinnitus. This product releases doses of lidocaine into nerve endings located behind the ear. Tinnitus is characterized by a constant or intermittent hissing, buzzing or ringing noise in the ear that affects over 50 million Americans. There are many causes of tinnitus, including defects in nerve conduction and one of the side effects of some medications; however, there are no currently approved treatments.

Stage of Development

While an IND application for LidoPAIN TV has not been submitted to the FDA, a foreign IND equivalent was filed by EpiCept in Europe in June 2001. A European Phase II clinical trial in subjects with tinnitus was completed in 2002. Subjects utilizing the LidoPAIN TV patch perceived a beneficial effect as compared to subjects given the placebo patch.