NortheraTreatment for Neurogenic Orthostatic Hypotension
Chelsea Therapeutics Announces FDA Acceptance of Northera (droxidopa) NDA Resubmission
CHARLOTTE, N.C., July 17, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission seeking approval to market Northera (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (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. The FDA has deemed the resubmission a complete response to its March 28, 2012 Complete Response Letter and assigned a new Prescription Drug User Fee Act (PDUFA) goal date of January 3, 2014.
"Northera holds the potential to serve as an important new therapeutic option for patients living with the debilitating effects of NOH," said Joseph G. Oliveto, Interim Chief Executive Officer of Chelsea. "FDA acknowledgement of the completeness of our NDA resubmission is another key milestone in reaching this goal. We will continue to work closely with the FDA toward an approval decision for Northera by early next year, and advance our commercial strategy in anticipation of a U.S.
commercial launch soon after this."
Northera was previously granted Orphan Drug Designation and received Fast Track designation from the FDA. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need.
About Symptomatic NOH
NOH is a chronic neurogenic disorder resulting from deficient release of norepinephrine that predominantly affects patients with primary autonomic failure, a group of diseases which includes Parkinson's disease (PD), multiple system atrophy (MSA) and pure autonomic failure (PAF). Symptoms of NOH include: dizziness, lightheadedness, blurred vision, fatigue, poor concentration, and fainting episodes when a person assumes a standing position, often severely limiting a person's ability to perform routine daily activities that require standing or walking for both short and long periods of time.
Northera (droxidopa), the lead investigational agent in Chelsea Therapeutics' pipeline, is currently in Phase III development for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure -- an indication that includes a significant number of patients with 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, developed by and licensed from Dainippon Sumitomo Pharma Co., Ltd. (DSP), initially received Japanese approval in 1989 for the treatment of frozen gait and dizziness on standing associated with Parkinson's Disease and for the treatment of orthostatic hypotension, syncope or dizziness on standing associated with Shy-Drager syndrome and Familial Amyloidotic Polyneuropathy. In 2000, Droxidopa received expanded marketing approval to include prevention of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients.
About Chelsea Therapeutics
Chelsea Therapeutics (Nasdaq: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 (droxidopa), a novel, late-stage, orally-active therapeutic agent for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure.
This press release contains forward-looking statements regarding future events including our intention to pursue the development of Northera.
These statements are subject to risks and uncertainties that could cause the actual events or results to differ materially. These include reliance on key personnel and our ability to attract and/or retain key personnel; the risk that FDA will not agree that our clinical trial results demonstrate the safety and effectiveness of droxidopa; the risk that the FDA will not accept our proposal regarding any trial or other data to support a new drug application; the risk that the FDA will not approve the resubmitted NDA; the risk that our resources will not be sufficient to conduct 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 that we will not be able to obtain regulatory approvals of droxidopa or our other drug candidates for additional indications; risk of volatility in our stock price, related litigation, and analyst coverage of our stock; reliance on collaborations and licenses; intellectual property risks; our history of losses; competition; market acceptance for our products if any are approved for marketing.
Posted: July 2013
- FDA Approves Northera to treat Neurogenic Orthostatic Hypotension - February 18, 2014
- Chelsea Therapeutics Issues Statement Regarding Postponement of Northera NDA PDUFA Date - February 14, 2014
- FDA Advisory Panel Recommends Approval of Chelsea Therapeutics' Northera (Droxidopa) for the Treatment of Symptomatic nOH - January 14, 2014
- Chelsea Therapeutics Announces FDA Advisory Committee to Review Northera - October 9, 2013
- Chelsea Therapeutics Announces FDA Acceptance of Northera (droxidopa) NDA Resubmission - September 4, 2013
- Chelsea Therapeutics Announces Submission of Additional Information for Northera NDA - August 15, 2013
- Chelsea Therapeutics Resubmits New Drug Application for Northera (droxidopa) for the Treatment of Symptomatic NOH - July 9, 2013
- Chelsea Therapeutics Receives FDA Guidance for a Northera (Droxidopa) NDA Resubmission With Study 306B - February 20, 2013
- Chelsea Therapeutics Provides an Update on Northera (droxidopa) Regulatory Status and Development Program - July 3, 2012
- Chelsea Therapeutics Completes End-of-Review Meeting With FDA for Northera (droxidopa) NDA - May 22, 2012
- Chelsea Therapeutics Receives Complete Response Letter from Food and Drug Administration for Northera (droxidopa) Capsules - March 28, 2012
- FDA Advisory Panel Recommends Approval of Chelsea's Northera (droxidopa) for the Treatment of Symptomatic Neurogenic OH - February 24, 2012
- Chelsea Therapeutics CEO to Review Northera NDA and Provide an Update on Upcoming Advisory Committee Meeting During Presentation at BIO CEO - February 14, 2012
- Chelsea Therapeutics Announces FDA Advisory Committee Meeting Date for Review of Northera NDA for the Treatment of Symptomatic NOH - January 5, 2012
- Chelsea Therapeutics Submits New Drug Application for Northera (droxidopa) for the Treatment of Symptomatic NOH - September 28, 2011
- Chelsea Therapeutics Accelerates Northera NDA Filing Following Meeting With FDA - December 20, 2010
- Chelsea Therapeutics Announces Advancements in Neurogenic Orthostatic Hypotension Registration Program - February 9, 2010