Dry mouth treatment in cancer patients shows positive trial results

A new drug for the treatment of dry mouth in cancer patients has shown positive results in a Phase II clinical trial. APD515, developed by Acacia Pharma, has been shown to work well, when compared to results obtained by a placebo, for the treatment of xerostomia. The drug is a liquid formulation of a product that is already on the market as a patented xerostomia treatment. 

Dry mouth is commonly experienced by cancer patients, especially throughout certain treatments, and can be a distressing symptom, according to Doctor Julian Gilbert, chief executive of Acacia Pharma. Not only can it lead to a reduction in the quality of a patient's life, Doctor Gilbert continued, but it can cause a number of complications.

The Phase II trial was a randomised, double-blind, placebo-controlled study, performed across a total of 11 centres throughout both Denmark and England. Some 32 patients were part of the trial, all of whom have advanced cancer with a symptom being persistent dry mouth. Each patient was given APD515 for a week and then a placebo for another week.

Each patient subjectively scored the level of their dry mouth, with 100 being the driest possible and zero being no dryness. Following treatment with APD515, the average patient score was 26.01, in comparison to 43.52 following the placebo treatment. Patients also scored aspects such as difficulty speaking, oral comfort and difficulty swallowing, all of which scored higher following APD515 treatment when compared to the placebo's scores.

After the trial the majority of patients chose APD515 as their preferred course of treatment, on a blinded basis. While 19 participants preferred the actual treatment, only one chose the placebo.  

Doctor Gabriel Fox, chief medical officer at Acacia Pharma, said: "This was a robust trial, whose cross-over design allowed us to compare the effects of APD515 and placebo in the same patient. The study has shown an unequivocal benefit for APD515 in advanced cancer patients suffering with a dry mouth. APD515 is the first product opportunity to be developed in this hitherto poorly managed patient group."