Auris Medical Holding has announced that a PK study of an intranasal betahistine formulation demonstrated 5-35 times higher bioavailability in dogs compared to oral betahistine, and a Phase 1 study showed 20-40 times higher bioavailability for the intranasal formulation compared to oral betahistine in humans. The company is developing AM-125 intranasal betahistine for the treatment of vertigo.
The company also said that it plans to begin enrolling healthy volunteers in a second Phase 1 trial to determine maximum tolerated dose by the end of the first quarter of 2018, with results expected to be available by mid-year.
Auris Medical Founder, Chairman, and CEO Thomas Meyer said, “We are very pleased to see the superior bioavailability of intranasal betahistine confirmed further based on animal and human study data. Although oral betahistine in many cases is the drug of choice for treating vestibular disorders, it is also well known that the drug is not used most effectively with current standard oral doses due to its rapid metabolization. We believe that the intranasal route offers significant additional benefits in terms of efficacy and tolerability. We plan to bring this new treatment option to patients in key markets, including in the US where the compound currently is not approved.”
Read the Auris Medical press release.