Policy & Regulation
Sound Pharmaceuticals awarded FDA's Fast Track Designation for SPI-1005 for treating Meniere's Disease
19 September 2019 -

Biotechnology company Sound Pharmaceuticals disclosed on Wednesday that it has received the US FDA's Division of Neurology Products' Fast Track Designation for the expedited development of SPI-1005 for the treatment of Meniere's Disease (MD).

MD is diagnosed by episodic vertigo, fluctuating hearing loss and intermittent or constant tinnitus and is thought to be due to a swelling or inflammation of the inner ear. MD patients are typically diagnosed between 40 and 65 years of age.

The company said SPI-1005 is an investigational new drug that contains ebselen, a small molecule that is a new chemical entity, or NCE, under FDA classification. Ebselen is a selenorganic compound that mimics and induces glutathione peroxidase (GPx) activity and represents a novel class of anti-inflammatory. SPI-1005 is given orally and is being tested in several neurotologic indications.

Based on the clinical data from two completed multi-centre, randomised, placebo-controlled Phase 1b and Phase 2b clinical trials, oral delivery of SPI-1005 for 21 or 28 days improved tinnitus and restored sensorineural hearing loss in patients affected by MD. The patients' tinnitus and vertigo were assessed using the Tinnitus Functional Index (TFI) and Vertigo Symptoms Scale (VSS).

Sound Pharmaceuticals has an End-of-Phase 2 Meeting scheduled with the FDA to discuss the pivotal Phase 3 study design and additional data required for NDA filing.