This is old I believe. Some data were likely presented to FDA from this last Fall when Hemispherix was trying to get Ampligen approved but failed due to, as I understand, incomplete data. Peterson et al. might be pushing another trial but that would be aside from this one. Hemispherix has long history of not fully allowing researchers/ clinicians/ the public access to the data.
A drug called droxidopa is now moving into phase II clinical trials as a treatment for chronic fatigue syndrome.
Droxidopa is a synthetic version of a substance your body uses to make the neurotransmitter/hormone norepinephrine. Norepinephrine performs several important functions, and you body also uses it to produce dopamine, another important neurotransmitter. Studies have shown that this drug can improve fatigue, weakness, concentration, and orthostatic hypotension (blood pressure drop upon standing, which causes dizziness) in several conditions, including Parkinson's disease. These symptoms are also common in chronic fatigue syndrome, and studies show that some people with this condition may have low levels of norepinephrine and dopamine.
The study will take place at the Hunter-Hopkins Center in Charlotte, North Carolina, under the supervision of Dr. Charles Lapp. Lapp has been involved in both the American Association for CFS and the American Fibromyalgia Syndrome Association.
Droxidopa also is being studied as a possible fibromyalgia treatment. It is not yet approved for any use in the U.S. However, its manufacturer, Chelsea Therapeutics, is working toward approval for neurogenic orthostatic hypotension.
Droxidopa is an orally active synthetic precursor of norepinephrine currently approved and marketed in Japan for the treatment of orthostatic hypotension. By replenishing depleted norepinephrine via endogenous enzymatic pathway, Droxidopa allows for re-uptake of norepinephrine into peripheral nervous system neurons stimulating receptors for vasoconstrinction and providing physiological improvement in symptomatic neurogenic orthostatic hypotension patients.
With over 15 years of proven safety and efficacy in its target indications, Droxidopa provides a unique opportunity to accelerate Chelsea's drug development activities, expand its product pipeline and help finance the establishment of a sales and marketing infrastructure prior to commercialization of the companys other compounds including CH-1504.
Originally approved in 1989 for the treatment of frozen gait or dizziness associated with Parkinson's Disease and for the treatment of orthostatic hypotension, syncope or dizziness associated with Shy-Drager syndrome and Familial Amyloidotic Polyneuropathy, DSP expanded marketing approval in 2000 to include treatment of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients.