Chelsea Therapeutics International Ltd. recently resubmitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for Northera (droxidopa). The company 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 neuropathy.
Results from 306 B, a large phase III study demonstrating improvement in dizziness / lightheadness, the main symptom of NOH and confirming findings from the previous 301 study, was included in the resubmitted NDA.
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 recommended that Chelsea Therapeutics should 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, 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 program by Chelsea Therapeutics.
Taking note of this, Chelsea Therapeutics included a bioequivalence study for the 300 mg dose in the resubmitted NDA.
The resubmitted NDA will most likely come up for review before the FDA’s Cardiovascular and Renal Drug Advisory Committee (CRDAC). There is also a possibility raised by the FDA about Northera gaining accelerated approval and hinted that short-term clinical benefit would be considered adequate replacements to predict long-term clinical benefits under the accelerated approval.
Northera was granted orphan drug designation in 2007 and received fast track designation.
Chelsea Therapeutics currently carries a Zacks Rank #3 (Hold). A response from the FDA regarding Northera’s approval status should be out early next year. At present, companies that look well-positioned include Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) , Targacept, Inc. and Palatin Technologies Inc. (PTN - Free Report) . All these biopharma stocks carry a Zacks Rank #1 (Strong Buy).