Interim Results of Phase II Trial for the Treatment of Sialorrhea to be Presented at Movement Disorder Society International Congress June 11th

June 09, 2009 (PRLEAP.COM) Business News
Newton, Massachusetts June 9, 2009 NeuroHealing Pharmaceuticals, a private, clinical stage company developing innovative drug treatments for specialty indications based on repositioning neurologically active compounds, announces the presentation of pre-planned interim clinical results of a phase II trial with NH004 for the treatment of sialorrhea (uncontrolled drooling) in Parkinson's disease patients at the MDS 13th International Congress of Parkinson's Disease and Movement Disorders (June 7-11, 2009 in Paris).

Parkinson's disease (PD) patients complaining of sialorrhea were randomized to receive treatment with three doses of NH004 and placebo. A planned interim analysis of the first 12 PD patients treated indicated that NH004 produced a dose-dependent decrease in drooling in Parkinson's patients, as measured by a subjective assessment of saliva in the mouth. The maximal differences between NH004 and placebo were observed at 60 and 90 min post-dose. No adverse events were detected in any of the treatment sequences. Based on these results, a study in a larger group of PD patients is now underway using an additional quantitative saliva measurement at the observed activity times.

NeuroHealing is conducting these clinical studies of NH004 at the FLENI Hospital in Buenos Aires, Argentina. Dr. Perez-Lloret's poster presentation on June 11, 2009 is entitled "A Phase II, double-blind, placebo-controlled, randomized, crossover pilot study of the safety and efficacy of multiple doses of intra-oral tropicamide films for the short-term relief of sialorrhea symptoms in Parkinson's Disease patients: an interim analysis."

This trial is being funded by The Michael J. Fox Foundation for Parkinson's Research and NeuroHealing. The Michael J. Fox Foundation is dedicated to ensuring the development of a cure for Parkinson's disease through an aggressively funded research agenda.

About Sialorrhea
Sialorrhea (drooling or uncontrolled salivation) is a major non-motor complaint in many patients suffering from various neurological impairments including Parkinson's disease (PD), cerebral palsy, ALS, stroke and other motor disorders. Sialorrhea is often described as the single most disabling social problem for many PD patients. It is a frequent, awkward and embarrassing condition, affecting up to 75 percent of patients with advanced PD. Depending on its degree, drooling can result in social and medical disability, impaired speech, or serious feeding difficulties. Unable to manage oral secretions, affected persons are at an increased risk of aspiration pneumonia, skin maceration, and infection.

About NH004
NH004 is an intra-oral, slow-dissolving film containing the fast acting anticholinergic agent tropicamide to control, on an as-needed basis, the symptoms of sialorrhea and the accompanying embarrassment and frustration to patients. The drug is embedded in a muco-adhesive film that is placed in the mouth and provides a slow, localized delivery while minimizing systemic exposure to the drug. This drug delivery is designed for effectiveness, safety and convenience. The film design is ideal for unobtrusive use in a social environment, to provide both supportive care and to improve quality of life.

About NeuroHealing Pharmaceuticals
NeuroHealing Pharmaceuticals, Inc. is a clinical stage private company developing innovative treatments for specialty indications based on repositioning neurologically active compounds. Clinical stage programs include: NH001 (phase II), a dopaminergic agent to help post traumatic brain injury patients to emerge from a coma, vegetative or minimally consciousness state; NH004 (phase II), an anticholinergic agent in a convenient intra-orally muco-adhesive dissolving film to help treat motor neuron disease patients who suffer from sialorrhea (drooling); and NH02D, a neurologically active compound to treat premature ejaculation.

NeuroHealing Pharmaceuticals, Inc.
Daniel Katzman, President