08:00 , Feb 2, 2015 |  BC Week In Review  |  Clinical News

Nepicastat: Phase II data

Top-line data from a double-blind, placebo-controlled, U.S. Phase II trial in 179 treatment-seeking cocaine-dependent patients showed that once-daily 120 mg oral nepicastat plus 100 mg riboflavin for 11 weeks missed the primary endpoint of a...
07:00 , Jun 2, 2014 |  BC Week In Review  |  Clinical News

Nepicastat: Completed Phase II enrollment

Biotie completed enrollment of 179 treatment-seeking cocaine-dependent patients in a double-blind, placebo-controlled, U.S. Phase II trial comparing 120 mg oral nepicastat once daily plus 100 mg oral riboflavin vs. riboflavin alone for 11 weeks. The...
08:00 , Feb 24, 2014 |  BC Week In Review  |  Clinical News

Northera droxidopa regulatory update

FDA granted accelerated approval to Northera droxidopa from Chelsea to treat neurogenic orthostatic hypotension (NOH). Specifically, the drug is indicated to treat orthostatic dizziness, lightheadedness or the "feeling that you are about to black out"...
08:00 , Dec 16, 2013 |  BC Week In Review  |  Clinical News

Northera droxidopa: Phase III started

Chelsea began the double-blind, placebo-controlled, international Phase III Study 401 to evaluate 100, 200 and 300 mg oral Northera for up to 17 weeks in about 450 symptomatic NOH patients with primary autonomic failure, dopamine...
07:00 , Aug 19, 2013 |  BC Week In Review  |  Clinical News

Northera droxidopa regulatory update

Chelsea said it submitted additional information to FDA regarding technical deficiencies identified in a resubmitted NDA for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH). In July, FDA accepted the resubmitted NDA and assigned...
07:00 , Aug 5, 2013 |  BC Week In Review  |  Clinical News

Northera droxidopa regulatory update

Chelsea said FDA will delay the 6-month PDUFA review period for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH) until the biotech addresses technical deficiencies identified in a resubmitted NDA. Chelsea said it expects...
07:00 , Jul 22, 2013 |  BC Week In Review  |  Clinical News

Northera droxidopa regulatory update

Chelsea said FDA accepted for review a resubmitted NDA for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. The PDUFA...
00:53 , Jul 18, 2013 |  BC Extra  |  Company News

FDA accepts Northera resubmission

Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) said FDA accepted for review a resubmitted NDA for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic...
07:00 , Jul 15, 2013 |  BC Week In Review  |  Clinical News

Northera droxidopa regulatory update

Chelsea Therapeutics resubmitted an NDA to FDA for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. The company said it...
07:00 , May 20, 2013 |  BC Week In Review  |  Clinical News

Nepicastat: Phase II started

Biotie announced the start of a double-blind, placebo-controlled, U.S. Phase II trial to compare 120 mg oral nepicastat once daily plus oral riboflavin vs. riboflavin alone for 11 weeks in about 180 treatment-seeking cocaine-dependent patients....