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NH001
– Coma recovery
NH001 promotes consciousness and improves the functional outcome
in patients in a post-traumatic coma, vegetative state or minimally conscious state.
The faster the patient recovers consciousness,
the better the chances for recovery of functionality.
As a result of trauma, portions of
the brain die. During the recovery process, the remaining functional
structures of the brain reorganize and take control of functions
formerly controlled by the now dead structures. This natural healing is mediated by a process that is referred to as neural plasticity. NH001 aims to provide the right
conditions in order to accelerate the neural plasticity process.
NeuroHealing has designed two clinical trials
to study the safety and efficacy of NH001 in accelerating the recovery
and improving the functional outcome of post TBI vegetative state and
minimally conscious state patients. The first clinical trial, a small
open label, Phase II study that has treated 8 patients at two sites, with dramatic
responses. NeuroHealing has received clearance
by the FDA to start a Phase II, 76-patient, double blind, placebo controlled trial.
Targeting a US market potential of $0.5 - 1 billion in peak revenues, this Phase II
clinical trials is ready to begin, with results available 18-24 months later.
- Get the NH001 Program Summary
NH004 – Sialorrhea
NeuroHealing is developing a novel treatment for
sialorrhea (drooling or un-controlled salivation), a major
non-motor complaint of Parkinson's Disease patients and often described
as the major debilitating social problem in many neurological
conditions including Cerebral Palsy, ALS, TBI and stroke. Current treatments,
which include surgery, Botox injections and oral anticholinergic
drugs, are unsatisfactory. NeuroHealing's approach is based on a
novel formulation of a safer anticholinergic compound that down-regulates secretory glands.
NH004 has already shown activity in clinical tests. It has a favorable
safety profile, a rapid onset and duration of action best to manage
the problem, and a convenient product form for use on an "as needed" basis for sialorrhea control.
- Get the NH004 Program Summary
NH02D – Premature Ejaculation
Premature ejaculation (PE) is the most prevalent male sexual disorder
affecting 20-30% of sexually active men and is even more prevalent
than erectile dysfunction. Currently, there are no clinically proven
products available for the treatment of PE in the United States or Europe.
NH02D is an orally administered drug that is being developed for
‘on-demand’ treatment of premature ejaculation (PE). As reported during
human studies for another indication and subsequently confirmed in
pre-clinical models, NH02D increases the time to ejaculation in males
with rapid or early ejaculation. NeuroHealing estimates that it can
start phase II testing in PE patients in late 2009 or early 2010,
and advance its clinical development under a 505(b)2 strategy,
resulting in an accelerated timeline.
- Request the NH02D Program Summary
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