RNID: For deaf and hard of hearing people.

Looking to test your compound for ototoxic side effects? MPI Research is experienced in ototoxicity safety evaluation, and has developed models for efficacy testing (cisplatin, otitis media, etc). MPI Research utilises transtympanic administration, catheter-assisted intrabullar administration, and other routine techniques for local and/or systemic exposures.  

The FDA (CDER) guidelines for Industry and Review Staff Non-clinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route (March 2008) specify that:

For products intended for Otic applications:

  • The dermal irritation and delayed contact hypersensitivity potential of the new formulation should be evaluated.
  • The ability of the drug to penetrate an intact tympanic membrane should be determined and the exposure to the middle and inner ears in an animal model should be estimated when this barrier is or is not intact.
  • If the drug is expected to reach the middle or inner ear during clinical use, evaluation of the auditory brainstem response, as well as microscopy of relevant otic tissues, including a cytocochleogram, should be included in acute and/or repeat dose studies conducted by intratympanic administration.

Examples of Ototoxic agents include:

  • Antibiotics (especially aminoglycosides)
  • Salicylates (aspirin)
  • Loop Diretics (furosemide)
  • Chemotherapeutics (platinum, vincristine, etc.)
  • Organic Solvents (benzene, toluene)
  • “Other” (carbon monoxide, mercury, environmental noise)

MPI Research provides a much needed service and collaborates with leading researchers at the Kresge Hearing Research Institute, University of Michigan. See their website (external link, opens new browser window) for further information.