Auris Medical Holding AG (NASDAQ:EARS) has new data on its pharmacokinetics of AM-125. The company was carrying out trials on the investigational drug to ascertain whether or not it can be used for the intranasal treatment of vertigo. The results were somewhat positive because they reflected remarkable higher blood plasma concentrations after the treatment was administered intranasally compared to oral administration.
The intranasal administration was of up to 120 mg doses while oral administration up to 48 mg/kg. Apparently, there was no compatibility in the absolute bioavailability because intranasal betahistine and oral betahistine reached 27 to 82% and 2 to 6% respectively.
The intranasal route seems to offer significant benefits
The study results have a lot to offer given that the relative bioavailability of intranasal betahistine was confirmed to be in a range of 5 to 35 times against that of oral betahistine. Overall, the authors of the study concluded that intranasal betahistine was well endured.
Thomas Meyer, Auris Medical’s founder, Chairman and Chief Executive Officer was excited about the superior bioavailability of intranasal betahistine. Meyer says, “We believe that the intranasal route offers significant additional benefits in terms of efficacy and tolerability.”
Apparently, oral betahistine has been regarded as the drug of choice in the treatment of vestibular disorders. However, word has it that it does not have the effectiveness, which could match the current standard of oral doses as a result of its rapid metabolization.
What next for Auris Medical?
The company seems to have big plans; one of them is bringing the new treatment options closer to the patients in key markets. One of the target markets is the US where it is yet to receive approval from the relevant authorities.
Further plans by the Swiss biopharmaceutical company includes the testing of intranasal betahistine in a second phase 1 clinical trial. This is expected to determine its maximum effectiveness. The study also intends to engage healthy volunteers later in the first quarter of 2018.