Objective/Rationale:
The goal of the research is to advance the clinical development of NH004 for the control of sialorrhea (excessive drooling or uncontrolled salivation). NH004 is a dissolving film containing an anticholinergic drug (tropicamide) designed to control sialorrhea and the accompanying increased risk of aspiration pneumonia. Drooling is a major non-motor complaint of Parkinson's disease (PD) patients, affecting up to 75 percent of patients in advanced stages of PD.
Project Description:
The NH004 films are thin strips that are placed inside the mouth to provide rapid sialorrhea relief. The films contain a muco-adhesive property to adhere to the inner side of the cheek, allowing a slow local release of the medication, and to allow unobtrusively use the films in a social environment. Researchers will carry out a Phase II blinded clinical study in 36 PD patients to test the efficacy of NH004 films in controlling the symptoms of excessive drooling.
Relevance to Diagnosis/Treatment of Parkinson’s Disease:
Drooling is a very significant problem that affects up to three-quarters of patients in advanced stages of PD. Depending on its degree, drooling can result in psychological and medical disability, impaired speech, serious feeding difficulties and risk of aspiration pneumonia, skin maceration and infection. NH004 films address an issue that is of high significance to PD patients and proposes a novel treatment approach that can lead to an approved drug.
Anticipated Outcome:
The results of this study are important to determine the efficacy response to various drug doses, and will allow planning larger clinical studies in the United States.
Final Outcome
After receiving the thin film non-treatment (placebo), there was a minor reduction of 5% in saliva compared to just before placement of the film. In contrast, NH004 reduced saliva by 27%, 33% and 20% after the low, medium and high doses, respectively. The data are encouraging and resulted in an additional study using the medium dose thin film being taken twice a day over a one week period. If effective, the new treatment would be a reasonable way to limit drooling for limited periods of time, especially in social settings.
This research was continued in a 2011 grant.