Acacia Pharma has initiated a phase I clinical study of APD515, an oromucosal formulation of an existing drug, for use in the treatment of xerostomia in advanced cancer patients.
APD515 has been specifically developed by Acacia Pharma to be delivered locally to the salivary glands distributed throughout the oral cavity, minimizing absorption into the general circulation and reducing the potential for side effects, according to the company.
The clinical trial is an ascending dose study of the pharmacokinetics and activity of APD515 in healthy volunteers, the company said. Each subject will receive APD515 given topically to the lining of the mouth at three different dose levels. The volunteers will also take APD515 orally to allow comparison of blood levels between topical and oral APD515. Salivary flow will be measured before and after dosing.
Initially, Acacia Pharma intends to develop APD515 for advanced cancer patients, 70% to 80% of whom suffer from xerostomia either as a direct result of their disease or their chemotherapy, or as a consequence of other medicines they are taking, such as tranquilizers, antidepressants, opioid painkillers and H2 blockers. APD515 may be developed in other patient populations once clinical proof of concept has been obtained within the advanced cancer population, the company said.
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