SPI-1005 for the Treatment of Patients With Meniere's Disease

Inclusion Criteria: * Adult male and female patients, 18-75 years of age at the time of enrollment. * Diagnosis of probable or definitive Meniere's disease by American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) 1995 criteria. * Two of three active symptoms including vertigo or disequilibrium, fluctuating hearing loss, or tinnitus within the 3 months prior to study enrollment. * Hearing loss of ≥ 30 decibels (dBHL) at either 250, 500 or 1000 Hz. * Voluntary consent to participate in the study. * Male subjects that are willing to use condoms throughout the study period and 90-days following study completion even if not fertile. * Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable birth control methods: * Intrauterine Device in place for at least 3 months prior to study; or * Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or * Stable hormonal contraceptive for at least 3 months prior to study and through study completion; or * Surgical sterilization (vasectomy) of partner at least 6 months prior to study enrollment. * Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study enrollment, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 1 …