FDA fast-tracking for drug to relieve tinnitus in Meniere's disease
meniere's
A drug shown in trials to relieve tinnitus and sensorineural hearing loss symptoms in Meniere's disease (MD) sufferers is being fast-tracked the the US Food and Drug Administration's (FDA) stringent new drug application process.
The drug—SPI-1005—belongs to the Seattle-based Sound Pharmaceuticals company. Positive top-line results from two completed multi-center, randomized, placebo-controlled studies have shown that oral delivery of SPI-1005 for 21 or 28 days improved tinnitus and restored sensorineural hearing loss in patients affected by MD. As a drug to treat serious conditions where the potential to address unmet medical need has been demonstrated, SPI-1005 qualifies for Fast Track Designation (FTD).
Among the symptoms of MD, which is thought to be be caused by inflammation of the inner ear, are vertigo, fluctuating hearing loss, and tinnitus, these latter two worsening with age. MD, which has a worldwide incidence of approximately 12 out of every 1,000 people (1), is currently managed with disappointing efficacy by low salt diets, thiazide diuretics, and oral or locally injected steroids. Right now there are no FDA-approved drug treatments for MD.
Until the drug gets final approval, the process must still pass through more frequent meetings with the FDA, rolling reviews, the possibility of priority review at the filing of New Drug Application (NDA), and an End-of-Phase 2 meeting with the FDA to discuss the pivotal Phase 3 study design and additional data required for NDA filing. But Jonathan Kil, MD, Co-Founder and CEO of Sound Pharmaceuticals is delighted with the fast-tracking for SPI-1005. "This is a major regulatory milestone for our most advanced clinical program to date," he said.
(1) Assimakopoulos D., Treatment of Ménière's disease by intratympanic gentamicin application.
Source: PR Newswire
