CHARLOTTE, N.C., May 1, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today reported financial results for the first quarter ended March 31, 2013. "In the first quarter, we made significant progress toward the commercialization of Northera™ (droxidopa) for the treatment of symptomatic Neurogenic Orthostatic Hypotension, a debilitating orphan condition that is greatly in need of alternative therapies," said Joseph G. Oliveto, Interim CEO of Chelsea. "Our team has navigated through the significant challenges of showing a symptomatic benefit in this difficult to treat disease state, and now, with updated guidance from the U.S. Food and Drug Administration, we have a regulatory path forward toward review and potential approval this year. We remain focused on resubmission of a New Drug Application for Northera in NOH." First Quarter Highlights
- In February 2013, Chelsea received written guidance from the Director of the Office of New Drugs at the U.S. FDA stating that Study 306B has the potential to serve as the basis for a resubmission of a Northera NDA for the treatment of symptomatic NOH. The Company intends to resubmit the Northera NDA in the second quarter or the early weeks of the third quarter of 2013. Chelsea also intends to initiate a new clinical trial in the fourth quarter of 2013, given FDA guidance regarding the potential need for Chelsea to verify the durability of effect of Northera in a post-marketing study.
- In March 2013, the results from Studies 306A and 306B were presented at the American Academy of Neurology's 65th Annual Meeting, where they were featured as part of the 2013 Emerging Science Program and highlighted by the AAN both in a data blitz and press release titled "New Drugs May Improve Quality of Life for People with Parkinson's Disease".