Newton, Massachusetts, May 6, 2013.

NeuroHealing Pharmaceuticals Inc., a private, clinical stage company announced today the treatment of the first patient in a Phase II study to test the efficacy of NH004 in reducing the symptom of sialorrhea (drooling) in Parkinson’s disease patients. NH004 is a novel slow dissolving intra-oral muco-adhesive thin film containing the anti-cholinergic drug tropicamide. The NH004-3 clinical trial is a double-blind, placebo-controlled, randomized, crossover, multicenter study comparing NH004 and placebo thin films in Parkinson’s disease patient complaining of sialorrhea ( identifier NCT01844648). This study is designed to demonstrate that NH004 provides better short term relief than placebo from sialorrhea symptoms in Parkinson’s disease patients when the films are used twice a day, in a home setting, over a period of one week. The NH004-3 study is being conducted in France at leading Parkinson’s disease clinical centers in Paris, Bordeaux and Toulouse. “We are pleased to have ADDS, an experienced and committed European CRO manage this Phase II trial,” said Elkan R. Gamzu, Ph.D., NeuroHealing NH004 Study Director. This clinical study builds on the encouraging findings of a previously completed NH004 trial (Lloret, SP, et al., J of Neurol Sci, 2011, 310:248-250). The NH004-3 study is funded in part by a clinical grant awarded to NeuroHealing from The Michael J. Fox Foundation, which also supported the first NH004 clinical study. About Sialorrhea 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. About NH004 NH004 is a novel treatment to control the symptoms of sialorrhea (excessive drooling) in patients suffering from Parkinson’s disease and other motor neuron disorders. The active ingredient in NH004 is the fast acting anticholinergic drug tropicamide, delivered in a thin film designed to adhere and slowly dissolve within the oral cavity to allow the drug to reach the underlying salivary gland, thereby reducing saliva secretions. The advantages of NH004 include local bioavailability with low systemic exposure, rapid onset of action and, importantly, 2 N E U R O H E A L I N G P H A R M A C E U T I C A L S I N C . 617. 965 – 0 8 7 2 – W W W . N E U R O H E A L I N G . C O M P O B O X 2 3 8 , W A B A N , M A 0 2 468 convenience of use for patients. 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 $325 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. For more information, visit 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 patients suffering from sialorrhea (drooling); and NH02D, a neurologically active compound to treat premature ejaculation.

Keywords: Parkinson’s, supportive care, sialorrhea, clinical trial, drug delivery


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