APD515 is an oromucosal liquid formulation of bethanechol, a muscarinic agonist known to stimulate saliva production. It has been evaluated in a Phase 2 proof-of-concept clinical study suggesting it is safe and effective at reducing xerostomia in advanced cancer patients.
Xerostomia is a subjective sensation of dryness in the mouth due to a reduction in the amount, or a change in the composition, of saliva secreted. It can lead to oral discomfort, taste impairment, difficulty chewing and swallowing, dental caries and increased oral infections. The condition in cancer patients is induced primarily by medication, e.g. specific cancer treatment or other medicines taken at the same time. Up to 500 commonly used medicines are associated with mouth dryness, including widely prescribed tranquilisers, antidepressants, anti-ulcer drugs, antihistamines and beta-blockers.
It is estimated that there are approximately 1.25 million advanced cancer patients in the US and Europe of whom up to 80% suffer from xerostomia. There are currently no drugs approved to treat xerostomia in this population