NeuroHealing Pharmaceuticals recently announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for patent application 11/240,281 entitled “High Potency Dopaminergic Treatment of Neurological Impairment Associated with Brain Injury.” U.S. Patent 7,943,632 will issue May 17, 2011.
The patent claims cover methods and pharmaceutical kits based on the drug apomorphine for the treatment of individuals who have sustained a traumatic brain injury and remain in an altered consciousness state: coma, vegetative state or minimally conscience state. Claims include methods to use apomorphine to improve functional independence of patients, various routes of administration and combinations with other therapeutic agents and medical device stimulation treatments.
NeuroHealing obtained Orphan Drug designation from the FDA for NH001 (continuous infusion apomorphine) for the treatment of patients in a vegetative or minimally conscious state following a brain injury, and an ongoing clinical study is funded in part by a three-year clinical grant from the FDA’s Office of Orphan Products Development.
NH001 is a potent dopaminergic agonist with well-established human safety data, appropriate pharmacokinetic profile and route of administration. It is a direct acting dopamine agonist at both D1 and D2 dopamine receptors. It rapidly crosses the blood brain barrier and reaches a concentration in the brain eight times higher than that in plasma. Because dopaminergic function appears to be of importance in executive central nervous system function, such as arousal and memory, NH001 has been designed to help regain consciousness, accelerate recovery and improve the functional outcome of patients from a coma, vegetative or minimally conscious state following a traumatic brain injury.
About Coma, Vegetative State and Minimally Conscious State
Each year in the U.S. 25,000 to 50,000 patients survive a severe TBI but remain in an altered consciousness state – such as coma, vegetative state or minimally conscious state – for an extended period of time. These ‘altered consciousness states’ are characterized by the lack of awareness and lack of interaction with the environment. Diffuse axonal injury, a neural pathology occurring in post-TBI patients, is associated with a disruption of dopamine pathways. There is evidence suggesting that dopamine agonists may have a role in regaining consciousness, facilitating rehabilitation and improving outcome. There are no approved drug treatments for post-traumatic patients who remain in a vegetative state or minimally conscious state.
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.