in off label cases such as hypotenisive shock cases in the emergency room visits (where hydration could a contraindication like patients with CHF for example or allergies to somatostatin and octreotide: drugs currently use in shock cases), and other outpatient settings where low blood pressure is the problem giving chronic dizziness, syncopal episode, and other hemodynamic events. Here's a good article where this drug is excellent for patients with spinal cord injuries. Then you can start thinking any neurological diseases that affects the patient hemodynamic status: Parkinson's, AZ, Huntington's chorea, etc. Know the science and you'll hemodynamically sleep good at night.
I 'm in since $1.79 and held through the drop because I knew the science and was confident with the drug. Now do you think I'm selling tomorrow? I'm probably not even looking tomorrow since I would be too busy seeing patients. But I can see where this drug could be used in so many off label cases and eventually probably FDA indicated in the future. I'm tempted to even load up more right at the opening.
Sentiment: Strong Buy
Chelsea Therapeutics has also been conducting Phase II trials for the use of Northera to treat fibromyalgia and intradialytic hypotension (IDH), the latter of which can preclude the delivery of adequate doses of dialysis for patients with kidney disease. Another compound, CH-4051, is in Phase II development for use in the treatment of rheumatoid arthritis.
Like Oliveto explains, “This underutilized gem was serving patients well in Japan for years, but no one had the resources to bring it to the U.S. This is the niche that companies like Chelsea Therapeutics have significant opportunities to step in, license the drug, see it through FDA approval, and ultimately get it to market.”. Oliveto says, “The only thing that’s for certain is that we will not stay the same. We will grow.” He adds, “It is certainly possible today for a small company to come to the orphan market, where they’re not competing with the Pfizers of the world, and actually grow and commercialize a product.
“But for us, everything is on the table and we have to return value to our investors. Ultimately, we are about getting the drug to the patients. Whatever is the best path forward to accomplish that goal is what we will do.”
Thanks for the fine post! CHTP has more room to run- a prized orphan drug with many other potential indications, a developmental company that is poised to turn into a profitable enterprise. CHTP is a growth story and longs will be richly rewarded.
Hemodynamic effects of L-threo-3,4-dihydroxyphenylserine (Droxidopa) in hypotensive individuals with spinal cord injury.
Arch Phys Med Rehabil. 2013; 94(10):2006-12 (ISSN: 1532-821X)......
Wecht JM; Rosado-Rivera D; Weir JP; Ivan A; Yen C; Bauman WA.......
OBJECTIVES: To determine the effect of an escalating dose of droxidopa (100, 200, and 400 mg) compared with placebo on seated blood pressure (BP) in hypotensive individuals with spinal cord injury (SCI). Secondarily, we aimed to determine the effect of droxidopa on (1) supine BP and heart rate, (2) the change in BP and heart rate when these individuals were transferred from the supine to the seated position, and (3) adverse event (AE) reporting.
DESIGN: Open-label dose titration trial.
SETTING: A Veterans Administration Medical Center.
PARTICIPANTS: Participants with SCI (C3-T12) (N=10) were studied during 4 laboratory visits. Subjects visited the laboratory for about 5 hours on each visit, which incorporated a 30-minute seated baseline, a 30- to 60-minute supine, and a 4-hour seated postdrug observation.
INTERVENTIONS: Placebo on visit 1, droxidopa 100 mg on visit 2, droxidopa 200 mg on visit 3, and droxidopa 400 mg on visit 4.
MAIN OUTCOME MEASURES: BP and heart rate changes from baseline to the postdrug period, orthostatic heart rate and BP responses, and subjective AE reporting.
RESULTS: Seated BP was significantly elevated with 400 mg droxidopa compared with placebo and 100 mg droxidopa for 3 hours and was elevated for 2 hours compared with 200 mg droxidopa. Increase in supine BP was not worsened following droxidopa, and the expected fall in BP when transferred to the seated position was prevented with droxidopa 200 and 400 mg. There were no significant differences in the heart rate response or AE reporting among the study visits.
CONCLUSIONS: Our preliminary findings suggest that droxidopa, at the doses tested, does not cause excessive increases in supine BP and the 400-mg dose appears to be effective at increasing seated BP for up to 3 hours in persons with SCI.