FDA calls for more data from Chelsea Thera on Northera

The US Food and Drug Administration has issued a complete response letter regarding the New Drug Application for Northera (droxidopa) capsules, being developed by biotech company Chelsea Therapeutics International (Nasdaq: CHTP) calling for additional clinical efficacy data, with the news sending the stock 28% lower to $2.66 in pre-market trading yesterday.

The application, which was filed on September 28, 2011, seeks approval for the treatment of symptomatic neurogenic orthostatic hypotension (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 and was supported by the highly statistically significant (p=0.003) outcome of Study 301.

The CRL, which comes after a positive advisory committee vote last month (The Pharma Letter February 24), includes a request by the FDA that Chelsea submits data from an additional positive study to support efficacy demonstrated in Study 301 along with the recommendation that such a study be designed to demonstrate durability of effect over a two to three-month period.