FDA notes 'technical deficiencies' in Chelsea's drug filing

In another setback for Chelsea Therapeutics ($CHTP), drug regulators have identified certain technical deficiencies for the biotech's lead investigational therapeutic Northera (droxidopa) in a review of the company's resubmitted New Drug Application.

Northera is designed to prevent symptomatic neurogenic orthostatic hypotension--dizziness and fainting among patients with disorders of the nervous system, such as Parkinson's disease. The FDA denied approval for the therapy in March 2012, concluding that Chelsea would need to file positive data from additional studies. Regulators also raised safety concerns about the drug's links to a neurological condition and are considering a black box warning. The Charlotte, NC-based biotech resubmitted its application to the FDA earlier this month.

In the latest chapter in Chelsea's pipeline troubles, the FDA has notified Chelsea that the deficiencies are related to the formatting of certain electronic datasets and statistical programs describing the methods used to generate tables and listings that the company submitted. A company press release says the deficiencies the FDA noted are unrelated to study conduct, interpretability of study results or validity of study conclusions.

"The company believes that the matter can be resolved quickly, and expects to submit the necessary response in August," Chelsea said in a statement on Monday.

Earlier this month, Chelsea received written confirmation from the FDA that the resubmission was deemed to be a complete response to the FDA's March 2012 letter, and the company was assigned a new review date of January 3, 2014. That timeline will now be pushed back until the FDA receives a response with the agency's requested changes.

Shares of Chelsea were down 7.82% at $2.83 as of 9:15 a.m. Monday.

- here's the press release

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.