Chelsea Therapeutics International Ltd.
) recently announced that the US Food and Drug Administration
(FDA) has accepted new drug application (NDA) resubmitted by the
company for its pipeline candidate, Northera (droxidopa).
Chelsea Therapeutics is looking to get Northera approved 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
Results from a large phase III study (306 B) demonstrating
improvement in dizziness / lightheadness, the main symptom of NOH
and confirming findings from the previous 301 study, was included
in the resubmitted NDA. A final decision from the FDA is expected
by Jan 3, 2014 (target date).
Chelsea Therapeutics had initially submitted an NDA for
Northera in Sep 2011. However, the company received a complete
response letter (CRL) in Mar 2012. In the CRL, the FDA asked
Chelsea Therapeutics to conduct and submit data from an
additional positive study supporting efficacy in the 301 study.
The company was also asked to design a study which would
demonstrate durability of effect over a 2- to 3-month period.
In the CRL, the FDA also mentioned an additional
bioequivalence study for the approval of Northera 300 mg
capsules. Chelsea Therapeutics was considering making these
capsules commercially available to complement the 100 mg and 200
mg capsules which were being utilized in the clinical
Taking note of this, Chelsea Therapeutics included a
bioequivalence study for the 300 mg dose in the resubmitted NDA.
We believe investor focus will remain on the FDA decision on
Chelsea Therapeutics carries a Zacks Rank #4 (Sell).Right now,
Jazz Pharmaceuticals plc
) carriesa Zacks Rank #1 (Strong Buy).
Vertex Pharmaceuticals Inc.
) also look attractive with a ZacksRank #2 (Buy).
CHELSEA THERAP (CHTP): Free Stock Analysis
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