Acacia Pharma has posted positive results from its Phase II study of APD515 for the treatment of xerostomia (dry mouth) in advanced cancer patients. The study showed that APD515 hit its primary endpoint, significantly reducing the symptoms of dry mouth compared to placebo. APD515 is an optimised oromucosal (liquid) formulation of a currently marketed muscarinic agonist for the completely new, patent-protected use of treatment of xerostomia.

The randomised, double-blind, placebo-controlled, cross-over trial was conducted in 11 centers in the UK and Denmark, and enrolled 32 patients with advanced cancer and a persistently dry mouth. The study met its primary endpoint of a significant improvement in the subjective scoring of mouth dryness after one week of treatment with APD515 compared to placebo.The overall number of adverse events was low, with no significant difference between APD515 and placebo.

Acacia Pharma intends to develop APD515 in advanced cancer patients, while keeping the door open for other xerostomic patient populations. The company will optimize the formulation and presentation in preparation for Phase III testing in an advanced cancer population.