CHARLOTTE, N.C., Feb. 23, 2012 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP - News) today announced that the Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 7-4 with 1 abstention and 1 non-vote to recommend approval of NORTHERA(TM) (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (also known as Neurogenic OH or NOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
"Chelsea is committed to improving the lives of patients with Neurogenic OH," commented Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. "We believe our clinical data demonstrates the significant symptomatic benefit of Northera treatment across a broad range of Neurogenic OH symptoms. Since no other treatment has been proven to alleviate the symptoms of neurogenic OH or improve patients' ability to carry out activities of daily living, we continue to believe Northera could fill this unmet need for patients with Parkinson's disease, MSA, PAF and other neurologic diseases. We are pleased by today's panel vote and we look forward to continuing to work with the FDA in advance of the March 28, 2012 PDUFA action date."
While the FDA is not bound by the recommendations of its advisory committees, its guidance will be considered by the FDA in its review of the New Drug Application (NDA) that was submitted for Northera in September 2011. A Prescription Drug User Fee Act (PDUFA) action date for the Northera NDA has been scheduled for March 28, 2012.
Northera was previously granted Orphan Drug Designation, which is granted by the FDA to treatments for rare diseases/disorders.
Chelsea will host a conference call with investors to discuss the meeting at 5:30 PM ET. Interested investors may participate in the conference call by dialing 877-638-9567 (domestic) or 720-545-0009 (international). A replay will be available for one week following the call by dialing 855-859-2056 for domestic participants or 404-537-3406 for international participants and entering passcode 22815594 when prompted. Participants may also access both the live and archived webcast of the conference call on Chelsea's web site at http://www.chelseatherapeutics.com.
About Neurogenic Orthostatic Hypotension
Neurogenic orthostatic hypotension (also known as Neurogenic OH or NOH) is a chronic neurogenic disorder resulting from deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart to regulate blood pressure. This deficiency results in lightheadedness, dizziness, blurred vision, fatigue, poor concentration and fainting episodes when a person assumes a standing position. Symptoms of chronic neurogenic OH can be incapacitating, not only putting patients at high risk for falls and associated injuries, but also severely affecting the quality of life of patients.
About NORTHERA(TM) (droxidopa)
NORTHERA(TM) (droxidopa), the lead investigational agent in Chelsea Therapeutics' pipeline, has been studied in two Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension 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. Droxidopa previously demonstrated clinical benefits in treating both intradialytic hypotension and adult attention deficit hyperactivity disorder in Phase II trials and is currently being evaluated in an ongoing Phase II trial for the treatment of fibromyalgia.
About Chelsea Therapeutics
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea's most advanced drug candidate, NORTHERA(TM) (droxidopa), is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to droxidopa, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate (MTX).
This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include risk of FDA approval of Northera, risks and costs of drug development, risk of regulatory approvals of our other drug candidates, our reliance on our lead drug candidates droxidopa and CH-4051, reliance on collaborations and licenses, intellectual property risks, our need to raise additional operating capital in the future, our history of losses, competition, market acceptance for our products if any are approved for marketing, and reliance on key personnel including specifically Dr. Pedder.
Read more from the original source:
FDA Advisory Panel Recommends Approval of Chelsea's NORTHER(TM) (droxidopa) for the Treatment of Symptomatic ...
- Tango Parkinson's Therapy (Washington U. in St. Louis) - May 7th, 2011 [May 7th, 2011]
- Parkinson's Disease Treatment-Exercise Program-Part 2 of 4 - May 14th, 2011 [May 14th, 2011]
- Parkinson's Disease Stem Cell Treatment - Part 2 - May 21st, 2011 [May 21st, 2011]
- Deep Brain Stimulation treatment for Parkinson's disease - May 22nd, 2011 [May 22nd, 2011]
- Parkinson's Disease Treatment-Exercise Program-Part 4 of 4 - May 24th, 2011 [May 24th, 2011]
- James, Parkinson's disease, after stem cell treatment at Tiantan Puhua Hospital Beijing - May 30th, 2011 [May 30th, 2011]
- Parkinson's Disease Stem Cell Treatment - Part 1 - May 30th, 2011 [May 30th, 2011]
- Parkinson's Disease Treatment -- Mayo Clinic - June 2nd, 2011 [June 2nd, 2011]
- When should I start treatment if I have Parkinson's Disease? - June 3rd, 2011 [June 3rd, 2011]
- parkinson-treatment-with-cupping-4.flv - June 3rd, 2011 [June 3rd, 2011]
- New treatment options for Parkinson's Disease feat. Nashville Predators coach Brent Peterson - June 8th, 2011 [June 8th, 2011]
- Speech Treatment in Parkinson disease: Sharon Kha's Story - June 8th, 2011 [June 8th, 2011]
- How you can help cure Parkinson's - June 9th, 2011 [June 9th, 2011]
- TV9 - LADIES CLUB : "PARKINSON DISEASE" - CAUSE, SYMPTOMS - June 9th, 2011 [June 9th, 2011]
- Parkinson's Treatment: Case #1 - June 12th, 2011 [June 12th, 2011]
- parkinsons cure - June 17th, 2011 [June 17th, 2011]
- A Parkinson Patient Finds their Miracle. FCR Treatment helps Parkinson's Disease. - July 3rd, 2011 [July 3rd, 2011]
- Parkinson's Treatment: Case #2 - July 15th, 2011 [July 15th, 2011]
- TMJ Treatment Helping with Parkinson's Symptoms Dr. Gary Demerjian Burbank, California - July 15th, 2011 [July 15th, 2011]
- Parkinson's Treatment at Ta'ir Laser Center testimonial - July 16th, 2011 [July 16th, 2011]
- Parkinson's Disease client pre and post treatment - July 17th, 2011 [July 17th, 2011]
- Parkinson's Disease: Diagnosis, Causes and Treatment. Part 2 - July 18th, 2011 [July 18th, 2011]
- Parkinson's Disease: Diagnosis, Causes and Treatment part4 - July 18th, 2011 [July 18th, 2011]
- Glutathione for Parkinson's Disease. Learn why it helps symtoms - July 18th, 2011 [July 18th, 2011]
- Parkinson's Disease: Diagnosis, Causes and Treatment. - July 19th, 2011 [July 19th, 2011]
- parkinson-treatment-with-cupping-1.flv - July 20th, 2011 [July 20th, 2011]
- 7.30 - a treatment for Parkinson's Disease can cause problem gambling - July 27th, 2011 [July 27th, 2011]
- Parkinson's Disease Symptoms Improve with Non-Surgical TMJ Treatment: Dr. Gary Demerjian - July 29th, 2011 [July 29th, 2011]
- Werth Parkinson Centre, Daniella - Treatment - August 4th, 2011 [August 4th, 2011]
- 6.30 - Parkinson's treatment - August 19th, 2011 [August 19th, 2011]
- MDTV: New Drug Treatments for Parkinson's Disease - September 10th, 2011 [September 10th, 2011]
- Pakistan Parkinson's Disease patient Treatment, in chennai Surgery hospital - DINAMALAR - September 23rd, 2011 [September 23rd, 2011]
- Parkinson's treatment gives life back - October 2nd, 2011 [October 2nd, 2011]
- Parkinson Doctor Sarasota Discusses Parkinson's Disease Treatments - Video - October 15th, 2011 [October 15th, 2011]
- New treatments for Parkinson's disease - pt 1 - Video - October 16th, 2011 [October 16th, 2011]
- Parkinson's Disease Treatment - Year and a Half Later... - Video - October 19th, 2011 [October 19th, 2011]
- Still Life: The Search for a Parkinson's Cure - Video - October 22nd, 2011 [October 22nd, 2011]
- Can Exercise Treat Parkinson's? - Video - October 30th, 2011 [October 30th, 2011]
- Parkinsons Treatments | Symptoms Parkinsons - Video - November 2nd, 2011 [November 2nd, 2011]
- Symptoms - November 3rd, 2011 [November 3rd, 2011]
- Revolutionary Treatment for Parkinson's - Video - November 4th, 2011 [November 4th, 2011]
- Herbal Treatment for Parkinsons disease and recovery - Video - November 7th, 2011 [November 7th, 2011]
- Early Diagnosis and Treatment of Parkinson's Disease - Video - November 10th, 2011 [November 10th, 2011]
- Parkinson's Disease Treatment (part 1 of 4) at Penn Medicine - Video - November 15th, 2011 [November 15th, 2011]
- Parkinson's Disease Treatment - Video - November 18th, 2011 [November 18th, 2011]
- MDTV: Parkinson's Disease: Treating Off Times - Video - November 20th, 2011 [November 20th, 2011]
- parkinson-treatment-with-hijamah-therapy.3gp - Video - November 24th, 2011 [November 24th, 2011]
- parkinson-treatment-with-cupping-2.flv - Video - December 3rd, 2011 [December 3rd, 2011]
- Parkinsons Antioxident treatment before with Dr. Offutt.MOV - Video - December 7th, 2011 [December 7th, 2011]
- Teva Presenting Data on MS and Parkinson's Disease Treatments - Video - December 7th, 2011 [December 7th, 2011]
- LSVT® LOUD Treatment Benefits Parkinson's Disease Patient -- Hendricks Regional Health - Video - December 14th, 2011 [December 14th, 2011]
- Parkinson's Cure - Dating - Video - December 21st, 2011 [December 21st, 2011]
- Parkinson's Treatment part-2 - Video - December 29th, 2011 [December 29th, 2011]
- Parkinson's Treatment - Video - January 1st, 2012 [January 1st, 2012]
- Parkinson's Treatment - Deep Brain Stimulation - Video - January 2nd, 2012 [January 2nd, 2012]
- Parkinson's cure with out medicine - Video - January 10th, 2012 [January 10th, 2012]
- Parkinson's Disease and The Argentine Tango - Video - January 11th, 2012 [January 11th, 2012]
- Parkinson treatment shows positive results in clinical testing - Video - January 15th, 2012 [January 15th, 2012]
- Parkinson's Disease Treatment - Patient Testimony "Lad" - Video - January 27th, 2012 [January 27th, 2012]
- Parkinson - Video - January 27th, 2012 [January 27th, 2012]
- parkinson-treatment-with-cupping-3.flv - Video - January 28th, 2012 [January 28th, 2012]
- Parkinson's Disease: Balance, Gait (Walk) and Tremors Improve with New Non-Surgical Treatment Part 2 - Video - January 29th, 2012 [January 29th, 2012]
- Researchers visualize the development of Parkinson's cells - January 31st, 2012 [January 31st, 2012]
- NPH diagnosis in San Tan Valley man returns him to normal life - January 31st, 2012 [January 31st, 2012]
- Laser targeting could help fight Parkinson's - February 1st, 2012 [February 1st, 2012]
- Study of live human neurons reveals Parkinson's origins - February 7th, 2012 [February 7th, 2012]
- Lauren Sciences LLC awarded MJFF grant to develop a V-SmartTM therapeutic for Parkinson's disease - February 7th, 2012 [February 7th, 2012]
- "Biochemistry", Advances in Parkinson's Disease Treatment - Video - February 7th, 2012 [February 7th, 2012]
- Parkinson's Disease Symptoms Improve with Non-Surgical TMJ Treatment: Part 2 - Video - February 7th, 2012 [February 7th, 2012]
- Treatment of Parkinson's Disease Symptoms - Video - February 7th, 2012 [February 7th, 2012]
- Parkinson Disease - Surgical Treatment - Video - February 8th, 2012 [February 8th, 2012]
- MediGait Announces: GaitAid Device for Parkinson's Disease Shows Significant Step-initiation Improvement in New Trial ... - February 14th, 2012 [February 14th, 2012]
- Tai Chi Makes Parkinson’s Patients Steadier on Feet, Study Says - February 14th, 2012 [February 14th, 2012]
- Cleveland Clinic Joins 23andMe in the Search for Genetic Clues to Parkinson's Disease - February 14th, 2012 [February 14th, 2012]
- Cleveland Clinic to Recruit Parkinson's Patients for 23andMe - February 14th, 2012 [February 14th, 2012]
- Fairhope Parkinson's patient enters film in contest to awareness of disease - February 15th, 2012 [February 15th, 2012]
- Tai Chi may help Parkinson's patients regain balance - February 16th, 2012 [February 16th, 2012]
- Weight Training May Help Parkinson's Patients Retain Function - February 17th, 2012 [February 17th, 2012]
- Parkinson's Disease and Exercise: How Much Is Beneficial? - February 17th, 2012 [February 17th, 2012]
- Study shows exercise may help Parkinson's patients - February 17th, 2012 [February 17th, 2012]