CHARLOTTE, N.C., Nov. 6, 2012 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (CHTP) today announced results from a study of Northera(TM) (droxidopa) in hypotensive individuals with spinal cord injury at the 23rd International Symposium on the Autonomic Nervous System, which took place October 31 through November 3, 2012 in Paradise Island, Bahamas.
The poster, titled "Blood Pressure Effect of Droxidopa in Hypotensive Individuals with Spinal Cord Injury," (poster #62) highlighted results of a clinical study designed to determine the blood pressure effect of escalating doses of droxidopa (100 mg, 200 mg & 400 mg) during three laboratory visits in hypotensive subjects (n=10) with spinal cord injury (SCI). The level of SCI ranged from cervical to low thoracic lesions, all were chronically injured and non-ambulatory and 8 were motor complete.
Subjects were hypotensive at baseline (systolic BP: 87+/-14 mmHg; diastolic BP: 54+/-8 mmHg), and baseline BP did not differ among the 3 visits. Upon supine repositioning prior to drug administration, BP increased significantly (SBP: 101+/-11 mmHg; DBP: 62+/-7 mmHg; p<0.0001 versus seated baseline), regardless of dose, droxidopa did not augment the increase in BP upon supine repositioning. Seated BP was significantly increased from baseline after droxidopa in a dose-dependent manner (100 mg: 94+/-14/61+/-8 mmHg; 200 mg: 99+/-15/62+/-9 mmHg; 400 mg: 106+/-16/58+/-9 mmHg; p<0.0001). Although the elevation in seated BP was relatively modest, average 4-hour seated SBP & DBP were significantly increased with 400 mg droxidopa compared to 100 mg (p<0.001) and 200 mg (p<0.05).
"These preliminary data indicate that droxidopa increases seated BP in a dose-dependent manner without worsening supine increases in BP in hypotensive persons with SCI, suggesting a greater normalization of pressure across positional changes," said lead author Jill M. Wecht, Ed.D, Associate Professor of Medicine and Rehabilitation Medicine, the Mount Sinai School of Medicine. "Increasing seated blood pressure is an important clinical outcome in these individuals, because hypotension has been linked to deficits in memory and attention processing in the general population and in individuals with SCI. Further study of droxidopa is warranted in the SCI population."
About Northera
NORTHERA(TM) (droxidopa), the lead investigational agent in Chelsea Therapeutics' pipeline, is currently in Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure -- a group of diseases that includes Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally.
About Chelsea Therapeutics
Chelsea Therapeutics (CHTP) is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases, including central nervous system disorders. Chelsea is currently pursuing FDA approval in the U.S. for Northera(TM) (droxidopa), a novel, late-stage, orally-active therapeutic agent for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure. For more information about the Company, visit http://www.chelseatherapeutics.com.
This press release contains forward-looking statements regarding future events. These statements are subject to risks and uncertainties that could cause the actual events or results to differ materially. These include the risk that the FDA will not accept any proposal regarding any trial or other data to support Study 301 or any other study, including the primary endpoint; the risk that we will not be able to resubmit the NDA for Northera and that the FDA will not approve a resubmitted NDA; the risk that our resources will not be sufficient to develop any study of Northera that will be acceptable to the FDA; the risk that we cannot complete any additional study for Northera without the need for additional capital; the risks and costs of drug development and that such development may take longer or be more expensive than anticipated; our need to raise additional operating capital in the future; our reliance on our lead drug candidate droxidopa; risk of regulatory approvals of droxidopa or our other drug candidates for additional indications; reliance on collaborations and licenses; intellectual property risks; our history of losses; competition; and market acceptance for our products if any are approved for marketing.
Read the original:
Chelsea Therapeutics Announces Results From Northera(TM) (droxidopa) Study in Spinal Cord Injury at the 23rd ...
- Hungarian Spinal Cord Injury Patient - Stem Cell Treatment Experience - May 7th, 2011 [May 7th, 2011]
- Stem cell treatment for Spinal Cord Injury (SCI)-Osama - May 8th, 2011 [May 8th, 2011]
- Spinal Cord Injury Patient after Stem Cell Treatment - Juan Carlos Murillo - May 10th, 2011 [May 10th, 2011]
- Spinal Cord Injury patient 10 years after injury after Stem Cell Treatment - May 10th, 2011 [May 10th, 2011]
- Rap Toward a Cure for Spinal Cord Injury - May 11th, 2011 [May 11th, 2011]
- Christopher "Kit" Bond - Spinal Cord Injury Stem Cell Patient - May 20th, 2011 [May 20th, 2011]
- Stem Cell Treatment - Spinal Cord Injury (2) - May 21st, 2011 [May 21st, 2011]
- Spinal Cord Injury-After Treatment, Pt was completely paralyzed (2) - May 22nd, 2011 [May 22nd, 2011]
- Spinal Cord Injury-After Treatment, Pt was completely paralyzed (1) - May 23rd, 2011 [May 23rd, 2011]
- Dogs recover following new treatment for spinal cord injury - June 2nd, 2011 [June 2nd, 2011]
- Spinal Cord Injury Rehabiliation Success Story - June 3rd, 2011 [June 3rd, 2011]
- Stem Cells for Spinal Cord Injury: Community Outreach San Diego 2011 - Trish Stressman - June 7th, 2011 [June 7th, 2011]
- Stroke Client Gains Strength and Mobility in North Palm Beach Florida - June 9th, 2011 [June 9th, 2011]
- Spinal Cord Injury Chicago Rehabilitation Lokomat - June 10th, 2011 [June 10th, 2011]
- Spinal Cord Injury Treatment With Stem Cells - June 11th, 2011 [June 11th, 2011]
- Spinal Cord Injury Patient after Stem Cell Treatment - Wesley Hixen - June 12th, 2011 [June 12th, 2011]
- Stem Cell Therapy for Spinal Cord Injury - Injured Airline Pilot Flies Again - June 13th, 2011 [June 13th, 2011]
- David Chen: How would stem-cell therapies work in the treatment of spinal cord injuries? - June 17th, 2011 [June 17th, 2011]
- William Rader MD - Paralyzed Spinal Cord Injury Patient Walks Again - June 29th, 2011 [June 29th, 2011]
- The Spinal Cord Injury Treatment Team - July 4th, 2011 [July 4th, 2011]
- Introduction to the Bioness H200 Hand Rehabilitation System - July 14th, 2011 [July 14th, 2011]
- Organ repair using own stem cells -- brain, heart - Future Health keynote speaker - July 15th, 2011 [July 15th, 2011]
- 2011 Shriners Ride for Kids, Salt Lake City Utah. - July 17th, 2011 [July 17th, 2011]
- Degenerative Disc Disease: C5-C6 c6-C7 Treatment - July 18th, 2011 [July 18th, 2011]
- Rehabilitation Institute of Michigan's 60 Anniversary TV Commercial - July 18th, 2011 [July 18th, 2011]
- California Spinal Cord Injury Attorney: Obtaining damages for lifetime care. - July 19th, 2011 [July 19th, 2011]
- Physical and Mental Adjustments After a Spinal Cord Injury - July 19th, 2011 [July 19th, 2011]
- Comprehensive Inpatient Rehabilitation - July 28th, 2011 [July 28th, 2011]
- SCI Treatment Center at the Claremont Club - July 30th, 2011 [July 30th, 2011]
- Spinal Cord Inury Patient at XCell-Center- M. Hasan - August 5th, 2011 [August 5th, 2011]
- Spinal Cord Inury Patient at XCell-Center- K. Potts - August 6th, 2011 [August 6th, 2011]
- Magee Rehabilitation Hospital Foundation and Toyota 100 Cars for Good - August 13th, 2011 [August 13th, 2011]
- SCI_Celine_French_ifting_her_arms.wmv - September 1st, 2011 [September 1st, 2011]
- New Treatment May Help Paralyzed Patients Move Again By Dr.Zaghloul ahmed - September 1st, 2011 [September 1st, 2011]
- Claire Marsh - Spinal Cord Injury Part One - September 6th, 2011 [September 6th, 2011]
- Coping with spinal cord and traumatic brain injuries - September 10th, 2011 [September 10th, 2011]
- Stem Cell Treatment - Spinal Cord Injury (3) - September 15th, 2011 [September 15th, 2011]
- Stem Cell Treatment - Spinal Cord Injury (1) - September 20th, 2011 [September 20th, 2011]
- Stem cell treatment by Adiva Health Care India after Spinal Cord Injury - September 22nd, 2011 [September 22nd, 2011]
- Spinal Cord Injury Documentary: You Will Never Walk Again, Part 1 - September 24th, 2011 [September 24th, 2011]
- Claire Marsh Returns - Spinal Cord Injury Patient - September 25th, 2011 [September 25th, 2011]
- Spinal Cord Injury: Raising awareness about research and treatment for spinal cord injury - September 26th, 2011 [September 26th, 2011]
- Walking after Spinal Cord injury and Stem Cells - September 27th, 2011 [September 27th, 2011]
- New Treatments for Spinal Cord Injuries - October 10th, 2011 [October 10th, 2011]
- Claire Marsh - Spinal Cord Injury Part Two - Video - October 18th, 2011 [October 18th, 2011]
- Stem Cell Treatment for Spinal Cord Injury - Video - November 2nd, 2011 [November 2nd, 2011]
- Stem Cells - Treatment for Spinal Cord Injury - Video - November 2nd, 2011 [November 2nd, 2011]
- (Film Trailer) - The Spinal Cord Journey: Stem Cell Therapy Stories of Recovery - Video - November 27th, 2011 [November 27th, 2011]
- Stem Cell Treatment for T-6 Spinal Cord Injury - Video - December 7th, 2011 [December 7th, 2011]
- What is Project Walk Atlanta - Video - December 13th, 2011 [December 13th, 2011]
- Stem Cells Treatment for Spinal Cord Injuries, Successfully Results, Stem Therapy - Video - December 28th, 2011 [December 28th, 2011]
- Stem Cell Therapy for Spinal Cord Injury, India Mumbai - Video - January 6th, 2012 [January 6th, 2012]
- "April Crave", "Project Walk Spinal Cord Injury Recovery" - Video - January 10th, 2012 [January 10th, 2012]
- "Lori Hammond", "Project Walk Spinal Cord Injury Recovery" - Video - January 23rd, 2012 [January 23rd, 2012]
- "Chad C.""spinal cord Injury treatment" "spinal cord injury" "spinal cord injury recovery" - Video - January 23rd, 2012 [January 23rd, 2012]
- "Hugo Rodovalho", "Client Spotlight Project Walk Spinal Cord Injury Recovery" - Video - January 27th, 2012 [January 27th, 2012]
- "Cecilia V.", "Project Walk Spinal Cord Injury Recovery" - Video - January 27th, 2012 [January 27th, 2012]
- "Roy R.", "Project Walk Spinal Cord Injury Recovery" - Video - January 27th, 2012 [January 27th, 2012]
- "Angela", "Project Walk Spinal Cord Injury Recovery" - Video - January 27th, 2012 [January 27th, 2012]
- "Joey's Story", "Project Walk Spinal Cord Injury Recovery" - Video - January 27th, 2012 [January 27th, 2012]
- "Spinal Cord Injury", "A Story Of One" - Video - January 27th, 2012 [January 27th, 2012]
- Spinal Cord Injuries - The Healing Center Project! - Video - January 28th, 2012 [January 28th, 2012]
- "Crystal H.", "Project Walk Spinal Cord Injury Recovery" - Video - February 3rd, 2012 [February 3rd, 2012]
- "Dave D.", "Project Walk Spinal Cord Injury Recovery" - Video - February 5th, 2012 [February 5th, 2012]
- "Brook", "Project Walk Spinal Cord Injury Recovery" - Video - February 5th, 2012 [February 5th, 2012]
- "Ashley Vargas", "Project Walk Spinal Cord Injury Recovery" - Video - February 6th, 2012 [February 6th, 2012]
- "Nathan Bayer", "Project Walk Spinal Cord Injury Recovery" - Video - February 8th, 2012 [February 8th, 2012]
- "Annette Ross", "Project Walk Spinal Cord Injury Recovery" - Video - February 8th, 2012 [February 8th, 2012]
- "Joe Guintu", "Project Walk Spinal Cord Injury Recovery" - Video - February 8th, 2012 [February 8th, 2012]
- "Trevor Comeau,"Project Walk Spinal Cord Injury Recovery" - Video - February 9th, 2012 [February 9th, 2012]
- "Kyle Eade, "Project Walk Spinal Cord Injury Recovery" - Video - February 11th, 2012 [February 11th, 2012]
- Velomedix Receives IDE Approval to Evaluate the Use of Rapid Therapeutic Hypothermia in the Management of AMI Patients - February 14th, 2012 [February 14th, 2012]
- Neuralstem Announces Closing of $5.2-Million Registered Direct Offering - February 14th, 2012 [February 14th, 2012]
- Chamber May Open Window for Treating Spine - February 15th, 2012 [February 15th, 2012]
- InVivo Therapeutics’ CEO Frank Reynolds Scheduled to Appear on Fox News First and San Antonio Living - February 17th, 2012 [February 17th, 2012]
- High doses of 'load' slows loss of bone in spinal cord injury - February 17th, 2012 [February 17th, 2012]
- InVivo Therapeutics Announces Pricing of Public Offering of Common Stock - February 17th, 2012 [February 17th, 2012]
- High Doses of Load Slows Bone Loss in Spinal Cord Injury - February 21st, 2012 [February 21st, 2012]
- InVivo Therapeutics Announces Full Exercise of Over-Allotment Option - February 22nd, 2012 [February 22nd, 2012]
- InVivo Therapeutics Announces Net $18.1M In Offering - February 22nd, 2012 [February 22nd, 2012]