San Diego-based biopharmaceutical company, Otonomy, which develops and commercializes innovative therapeutics for ear diseases and disorders, provided an August 2016 update on its corporate activities and product pipeline. On its list of medications in development is OTO-104, an investigational drug designed to help patients with Ménière’s disease, a disorder or syndrome of the inner ear that can cause episodes of fluctuating hearing loss and dizziness (vertigo), among other symptoms.
According to the Otonomy news release, the study found that quarterly dosing of OTO-104 was well tolerated, and 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,” said 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.
The company also announced that a Phase 1 clinical safety trial of OTO-311, a drug designed to treat tinnitus, is ongoing. Otonomy reports that OTO-311 is a single-dose, sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine that is in development. Several dose cohorts in the Phase 1 clinical safety trial have been completed without concerns of patient tolerability. The trial will remain open in the second half of 2016 pending the potential evaluation of additional dose levels.
Among other successful drug development results reported by Otonomy, was the commercial availability of OTIPRIO (ciprofloxacin otic suspension) in the United States for the treatment of pediatric patients with bilateral otitis media with effusion (ear infection) undergoing tympanostomy tube placement (TTP).
“Throughout 2016, we will remain focused on laying the foundation for OTIPRIO by establishing broad awareness within the target physician audience and successfully building advocacy through the sample trial program,” said Weber. “The first quarter of launch has provided us with valuable experience in gaining formulary acceptance, which we believe will be supported by the assignment of a unique C code for OTIPRIO that was effective as of July 1, 2016.”
Source: Otonomy
Hi, Just like to ask for the latest update regarding OTO-104. i was diagnosed with menieres disease this year. when will it be available for public or in the market?
Hi, I was wondering about the progress of the menieres medication trials due to I have menieres and would like to know the progress medication trials for use by the public
Hello ,
I am a sufferer of Meniere’s to and really appreciate all these great efforts.
I will follow
Hello
I am from Canada and suffers a chronic Ménière’s disease for 8 years and vertigo is one that is my concern as when vertigo attacks I feel hopeless in all aspect . I been taking serc for 8 years it does help but lately over the y are I get more episode attacks
This y at I gave so many that I cannot do and focus in my job
Lost my job several times because of this vertigo
I want to know if the dexametazone is effective enigma go to me not get get s vertigo for a while
If there is somehow I can get the clinical trials for my Ménière’s diseased please email me back for any suggestion about my diseased
healthy u.s.a. male 60 years , extreme tinnitus from plane flight
If it will cure meniers disease why couldn’t it cure tinnitus?
So, is this helping patients with vertigo AND hearing loss? I’m not reading much about what symptoms from Ménière’s are being relieved. I’m a Ménière’s sufferer, and even hope is wonderful thing. I really hope this pans out.
I’m trting Steven Spring Protocol. Basically, he discovered its mostly is unresolved sinus infection or otitis that takes advantge of an immune system deficit. His approach utilises immunotherapy – among other things – to treat the underlying cause. Interesting stuff and its working – for me.
I am a sufferer of Meniere’s and also suffer with tinnitus in my left ear. I read this report with some hope that finally there might be some relief from this most horrible and life-changing disease. When will these drugs be available? The sooner the better. I look forward to hearing from you.
Hi Dave,
Thanks for your comment, which prompted a check of the Otonomy Inc. website for any updates on their drug trials. It looks like the Phase 3 trial for OTO-104 for treating Meniere’s will continue through 2017, with results expected at the end of the year. It has been granted Fast Track designation by the FDA, so this drug may be commercially available sooner than others…possibly in 2018? As for the tinnitus drug, OTO-311, that is still in Phase 1 drug trials through 2017. A timeline for Phase 2 of the OTO-311 drug trial has not yet been determined, so commercial availability of that drug may be a few years in coming. Here is the Otonomy link for any readers who wish to track their progress: http://www.otonomy.com/
Is it possible to be part of the trial to cure tinnitus in the United States?