ZUG, SWITZERLAND — Biopharmaceutical company Auris Medical Holdings announced late last month that the US Food and Drug Administration (FDA) granted Fast Track designation to its investigational drug, KeyzilenTM (AM-101). Keyzilen is esketamine gel for intratympanic injection, intended for acute peripheral tinnitus following cochlear injury or otitis media in adults.
The Fast Track designation by the FDA of an investigational drug helps expedite the review process to facilitate the development of drugs designed to treat serious or life-threatening condition and fill an unmet medical need.
“We very much appreciate the FDA’s support in the development of Keyzilen and look forward to working with the Agency to advance this potential first-in-class treatment,” –Andrea Braun, Head of Regulatory and Quality Affairs
Studies have found that the disability caused by tinnitus is among one of the most common chronic medical conditions in adults. While there are recognized best practices in treating patients with tinnitus, there are currently no proven pharmacological treatment designed for treating the condition.
Otonomy Completes Ménière’s Disease Drug Trial
San Diego-based company, Otonomy, announced this week the successful completion of a one-year, multi-dose clinical safety trial of its investigational drug OTO-104 in patients with Ménière’s disease.
OTO-104 is a sustained-exposure formulation of the steroid dexamethasone, to help address the severe hearing and balance symptoms associated with Ménière’s disease. The randomized, placebo-controlled clinical safety trial took place in the United Kingdom (UK) with more than 120 patients enrolled at multiple sites across the UK. The study found that quarterly dosing OTO-104 was well tolerated.
According to the news release from the company, there were no notable differences found in treatment emergent adverse events, audiometry or tympanometry between patients in the OTO-104 and placebo groups. Overall, the safety profile that was observed with quarterly dosing was comparable to that observed from previous clinical trials with a single dose of OTO-104.
“Since Ménière’s disease is a chronic disorder, the demonstration that repeat-dosing with OTO-104 is well tolerated by patients is an important component of our registration program. Furthermore, this clinical trial also provided helpful experience with the use of OTO-104 by investigators who are now recruiting patients in the ongoing single-dose AVERTS-2 Phase 3 efficacy trial.” –David A. Weber, PhD, Otonomy President and CEO
Currently, there are no FDA-approved drugs to treat Ménière’s disease. Therefore, if successful, Otonomy’s OTO-104 compound would be the first such drug to receive approval to treat the condition.
*Title image courtesy cranleighscientific