Chelsea Therapeutics International Ltd.
) recently announced that it received written guidance from the
Director of the Office of New Drugs at the US Food and Drug
Administration (FDA) regarding the resubmission of the New Drug
Application (NDA) for Northera (droxidopa).
The written guidance stated that Chelsea Therapeutics' results
from Study 306B can be used as the basis for the resubmission of
the Northera NDA to the FDA for the potential treatment of
symptomatic neurogenic orthostatic hypotension (NOH).
Chelsea Therapeutics' stock prices shot up approximately 152%
on the news.
The news is encouraging for the company. On the basis of the
FDA's response Chelsea Therapeutics now plans to resubmit the NDA
for Northera towards the end of the second quarter of 2013. If
the NDA is accepted by the Division of Cardiovascular and Renal
Products (DCRP), Northera will be reviewed for a period of six
months. Chelsea Therapeutics expects that the candidate will be
approved by the end of the year.
In Dec 2012, Chelsea Therapeutics had announced positive
results from the phase III Study 306B. The study evaluated the
safety and efficacy of Northera for the treatment of symptomatic
NOH associated with Parkinson's disease (PD). Results from the
study revealed that patients who were treated with Northera
showed significant improvements in dizziness/lightheadedness at
week 1 compared to that of placebo.
In Mar 2012, Chelsea Therapeutics had received a complete
response letter (CRL) from the FDA regarding the NDA for
Northera, which was initially submitted in Sep 2011. Later, in
Jul 2012, the FDA had advised the company to modify Study 306B to
support its application for approval of Northera.
The company also expects to initiate a new clinical trial by
the end of the year to verify the durability of effect of
Northera in a post-marketing study.
Chelsea Therapeutics currently has no approved products.
Northera is the lead investigational candidate at the company. We
remain concerned about the company's dependence on Northera for
success. A second CRL could be a huge setback for the company. We
expect investor focus to stay on the regulatory status of
We note that companies like
Teva Pharmaceutical Industries Limited
) also have products for the treatment of PD.
Chelsea Therapeutics currently carries a Zacks Rank #3 (Hold).
Other pharma stocks such as
BioDelivery Sciences International Inc.
) carry a Zacks Rank #2 (Buy).
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