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 ofOtolaryngology-Head and Neck Surgery (AAO-HNS) 1995 criteria.
• Two of three active symptoms including vertigo or disequilibrium, fluctuating hearingloss, 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-daysfollowing 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 followingacceptable 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 priorto screening through study completion; or
• Stable hormonal contraceptive for at least 3 months prior to study and throughstudy completion; or
• Surgical sterilization (vasectomy) of partner at least 6 months prior to studyenrollment.
• Females of non-childbearing potential should be surgically sterile (bilateral tuballigation with surgery at least 6 months prior to study enrollment, hysterectomy, orbilateral oophorectomy at least 2 months prior to study) or be at least 1 year sincelast menses.

Exclusion Criteria:

• Current use of or within 60 days prior to study IV ototoxic medications such aschemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycosideantibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; orloop diuretics including furosemide.
• History of otosclerosis or vestibular schwannoma.
• History of significant middle ear or inner ear surgery.
• Current conductive hearing loss, otitis media, or mixed hearing loss.
• Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal,endocrine, immunologic, or psychiatric disease.
• Current use or within 30 days prior to study enrollment systemic steroids or drugsknown to be strong inhibitors or inducers of cytochrome P450 enzymes.
• Hypersensitivity or idiosyncratic reaction to compounds related to ebselen orselenium.
• Female patients who are pregnant or breastfeeding.
• Participation in another interventional drug or device study within 30 days prior tostudy consent.