Clinical trials for inner ear drugs: Design and execution challenges

Jung, David; Rauch, Steven D.

doi:10.1016/j.heares.2018.03.020

Cited by 6 publications

(4 citation statements)

References 12 publications

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“…While there are no FDA approved drugs developed specifically to treat inner ear disease, approved drugs are used that provide systematic relief. [36] Previous and current methods used to treat HL include systemic administration, IT injections, cochlear implants, nanoparticle formulations and various other methodologies that place drug delivery materials on the RWM directly for osmotic delivery. Systemic delivery often fails to deliver the required amount of drug to the inner ear due to the blood labyrinth barrier, which simultaneously requires higher doses of these drugs to cross.…”

Section: Discussionmentioning

confidence: 99%

Dexamethasone (DXM)‐Coated Poly(lactic‐co‐glycolic acid) (PLGA) Microneedles as an Improved Drug Delivery System for Intracochlear Biodegradable Devices

Pawley

Goncalves

Bas

et al. 2021

Advanced Therapeutics

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Uniform drug delivery techniques are challenging to develop for the inner ear due to the complexity of the cochlear anatomy. A promising solution is the use of biodegradable polymers because the continuous release of therapeutics without introducing toxic compounds is desirable. Using a microneedle approach lends the polymeric microneedle the capability to be placed inside of the scala tympani, releasing drugs overtime. Poly(lactic-co-glycolic acid) (PLGA) microneedles is prepared by dissolving dimethyl sulfoxide with either a) Rhodamine B, to study the drug release profile in vitro, b) FM1-43, to study the drug release profile in vivo, or c) dexamethasone (DXM), to protect hair cell (HC) loss in vivo. The Rhodamine B studies show that the dye begins release from the microneedles within 30 min. The ototoxicity assessment of the DXM-coated microneedles in vitro shows a significant reduction of HC losses when compared to control microneedles in an ototoxic environment. In vivo data show reduced hearing threshold for animals treated with DXM-infused microneedles, providing a proof of concept of the methodology developed. Drug-infused polymeric microneedles provide a promising method to deliver DXM to the inner ear over controlled periods of time protecting hair cells, thus minimizing hearing loss (HL).

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Section: Discussionmentioning

confidence: 99%

Dexamethasone (DXM)‐Coated Poly(lactic‐co‐glycolic acid) (PLGA) Microneedles as an Improved Drug Delivery System for Intracochlear Biodegradable Devices

Pawley

Goncalves

Bas

et al. 2021

Advanced Therapeutics

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“…Los síntomas pueden ser unilaterales al principio, pero posteriormente casi el 80% de los pacientes presentan afectación de ambos oídos 2,17 . La progresión de la pérdida auditiva generalmente ocurre durante semanas o inclusive meses 18 .…”

Section: Cuadro Clínicounclassified

“…La enfermedad autoinmune del oído interno es una bulares como, ataxia, vértigo y tinnitus 4,19,20 . El diagnostico diferencial es fundamental, hasta un tercio de los casos, es secundaria a una enfermedad autoinmune sistémica como; lupus eritematoso sistémico, artritis reumatoide, síndrome de Sjogren y granulomatosis con poliangeítis 2,12,18 . dIAGNósTICO Al no poseer marcadores específicos para el diagnóstico de la enfermedad autoinmune del oído interno 2,12,21 , se ha vinculado los distintos biomarcadores inmunitarios asociados con inflamación sistémica y los trastornos autoinmunes los cuales carecen de especificidad y se han utilizado para descartar trastornos inmunitarios sistémicos asociados a pérdida de la audición [22][23][24] .…”

Section: Conclusiónunclassified

Autoimmune inner ear disease

Cabrera

Benavides

Suarez

et al. 2022

Rev. parag. reumatol

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“…One factor complicating inner ear therapy is the difficulty of delivering drugs to the inner ear after systemic administration. Multiple clinical trials have been conducted utilizing topical administration [ 6 ]. However, it is not commonly used clinically, and no such drug is currently available on the market.…”

Section: Introductionmentioning

confidence: 99%

Metformin Reduces the Incidence of Sensorineural Hearing Loss in Patients With Type 2 Diabetes Mellitus: A Retrospective Chart Review

Miwa¹,

Kita²,

Yamaguchi³

et al. 2022

Cureus

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Introduction and objectivesAcquired sensorineural hearing loss (SNHL) has become a critical societal issue in recent years. SNHL is considered a risk factor for type 2 diabetes mellitus (T2DM). Metformin is commonly used to treat T2DM. However, its effects on SNHL have not been reported yet. Hence, this study aimed to evaluate the association between the use of metformin and SNHL incidence. Patients and methodsIn this retrospective matched-cohort study, the medical records of 1219 patients with T2DM aged >18 years from our hospital's inpatient database from January 1, 2012, to December 31, 2019, were examined, and matched cohorts were generated (76 patients receiving metformin and 76 not receiving metformin). A multivariable logistic regression analysis was performed to investigate the factors influencing the incidence of SNHL. ResultsAfter adjustment by propensity matching, multivariable logistic regression analysis revealed that the nonuse of metformin increased the risk of developing SNHL (odds ratio, 0.26; 95% confidence interval, 0.07-0.93; p = 0.03). ConclusionsThis study demonstrated an association between the use of metformin and a reduced incidence of SNHL among patients with T2DM.

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Clinical trials for inner ear drugs: Design and execution challenges

Cited by 6 publications

References 12 publications

Dexamethasone (DXM)‐Coated Poly(lactic‐co‐glycolic acid) (PLGA) Microneedles as an Improved Drug Delivery System for Intracochlear Biodegradable Devices

Dexamethasone (DXM)‐Coated Poly(lactic‐co‐glycolic acid) (PLGA) Microneedles as an Improved Drug Delivery System for Intracochlear Biodegradable Devices

Autoimmune inner ear disease

Metformin Reduces the Incidence of Sensorineural Hearing Loss in Patients With Type 2 Diabetes Mellitus: A Retrospective Chart Review

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