Newton, Massachusetts – December 10, 2010.
NeuroHealing Pharmaceuticals, a private, clinical stage company developing innovative drug treatments for specialty indications based on repositioning neurologically active compounds, announces the presentation of clinical trial results with NH004 for the treatment of sialorrhea (uncontrolled drooling) in Parkinson’s disease patients. The presentation today at the International Congress on Mental Dysfunctions & Other Non-Motor Features in Parkinson’s Disease (Barcelona, Spain) 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.” Parkinson’s disease (PD) patients complaining of sialorrhea were randomized to receive treatment with three doses of NH004 and placebo. Results of this pilot, proof-of-concept study showed that NH004 produced a reduction in drooling, as determined by two outcomes measurements. No adverse events were detected in any of the treatment sequences. This is the first randomized, double-blind controlled clinical study of the acute effect of anti-cholinergic drug treatment for sialorrhea in PD patients and demonstrated that NH004 may be an effective and safe therapy for ‘as needed” sialorrhea control. NeuroHealing conducted this NH004 clinical study at the FLENI Hospital in Buenos Aires, Argentina by investigators including Santiago Perez Lloret, Gabriela Nano and Marcelo Merello. Support for the trial was provided by The Michael J. Fox Foundation for Parkinson’s Research and by 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.
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.
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 mucoadhesive film that is placed in the mouth and provides a slow, localized delivery while NEUROHEALING PHARMAC EUTICALS INC. 617.331.4111 – WWW.NEUROHEALING.CO M 50 UNDINE RD, UNIT #1. NEWTON, MA 02135 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.