Newton, Massachusetts – August 26, 2011.
NeuroHealing Pharmaceuticals, a private, clinical stage company developing drug treatments for individuals with neuro-rehabilitation needs, announced today that The Michael J. Fox Foundation for Parkinson’s Research (MJFF) has awarded the company a grant to advance the clinical development of NH004, a novel treatment for sialorrhea (uncontrolled drooling). This grant will be used to support a multicenter double-blind, placebo controlled crossover study testing NH004 in Parkinson’s disease (PD) patients suffering from sialorrhea. This is the second grant to NeuroHealing from MJFF. A previous award funded a successful NH004 clinical study, the results of which have just been published (Lloret, SP, et al., “A 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”, J of Neurol Sci, 2011). “We are very grateful to The Michael J. Fox Foundation for this continued funding for the clinical development of NH004,” commented Neal M. Farber, Ph.D., CEO of NeuroHealing. “It emphasizes the medical need for a treatment to control sialorrhea in PD patients and supports the promise of an effective, convenient therapy.”
Sialorrhea (drooling or uncontrolled salivation) is a common non-motor complaint in many patients suffering from various neurological impairments including Parkinson’s disease (PD). Sialorrhea is often described as the single most disabling social problem for many PD patients. It is a frequent, awkward and embarrassing, but often not discussed, 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. Numerous approaches have been attempted to treating sialorrhea in PD patients, however, they are not satisfactory.
NH004 is an intra-oral, slow-dissolving film containing a fast acting anticholinergic agent to control 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 of the medication while minimizing systemic exposure to the drug. This drug delivery is designed for effectiveness, safety and convenience. The NH004 film design is ideal for unobtrusive use in a social environment and to provide supportive care and improve quality of life.
About The Michael J. Fox Foundation for Parkinson’s Research
As the world’s largest private funder of Parkinson’s research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $250 million in research to date, the Foundation has NEUROHEALING PHARMAC EUTICALS INC. 617.331.4111 – WWW.NEUROHEALING.COM 50 UNDINE RD, UNIT #1 – NEWTON, MA 02135 2 fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson’s research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson’s disease clinical trials; promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world. For more information, visit www.michaeljfox.org
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.