Drug repositioning for the treatment of Otitis Media with Effusion

Expanding on current technologies, University researchers have suggested new therapies for treating middle ear conditions in children. This new development can stop children from needing surgery.

The technology

Research conducted by Associate Professor Colin Anderson and Dr Burkard Franz, from the Department of Anatomy and Cell Biology (Faculty of Medicine, Dentistry and Health Sciences), have suggested that applying betahistine, an off-patent drug marketed by Abbott Product, topically can improve middle ear ventilation. A patent has been filed by the University covering this invention.

Eustachian tube, or the middle ear, dysfunction represents the primary underlying pathological mechanism and hence represent potential therapeutic indications. A common childhood condition is called Otitis Media with Effusion (OME), which is a serous or mucoid, but not mucopurulent, fluid in the middle ear. Whilst OME occurs in adults and children, it’s concerning in children because it can cause hearing impairment and have adverse effects on language development. OME accounts for 25–35% of all cases of Otitis Media. In 2001, the number of GP consultations for OME was reported to be about 17 per 1000 per year in 2–10 year olds. One study in the UK found that, at any time, 5% of children aged five years had at least three months of bilateral hearing impairment associated with OME.

There isn’t a therapy that’s been clinically proven to have long term benefit in treatment of OME. While current guidelines in the management of OME recommend watchful waiting of children for three months, many GPs prescribe steroids and other agents, which have no evidence to support their long term benefit in treatment of this disorder. OME is the most common reason for referral for surgery in children in the UK, who undergo a tympanostomy procedure involving inserting grommets into the eardrum to alleviate the presence of middle ear fluid.

The partnership

University of Melbourne Commercial created a start-up company,named Otifex Therapeutics to commercialise this invention.

The outcome

In June 2011, the University of Melbourne announced that Otifex Therapeutics had raised $1.1m from Uniseed and the Medical Research Commercialisation Fund, administrated by Brandon Capital Partners.

The investment funding was to be used in reformulating the technology for nasal delivery, pharmacology and safety experiments, manufacture, and a Phase I clinical trial to confirm the nasal formulation’s safety.