17:18 , Mar 9, 2018 |  BC Week In Review  |  Clinical News

Vanda's Hetlioz meets in Phase III for jet lag disorder

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) reported data from the double-blind, U.S. Phase III JET8 trial in 318 healthy volunteers undergoing a circadian challenge of an eight hour advance to their usual bedtime to induce jet lag...
17:28 , Feb 16, 2018 |  BC Week In Review  |  Clinical News

Neurim's PedPRM meets in Phase III for insomnia in children with autism

In October, Neurim Pharmaceuticals Ltd. (Tel Aviv, Israel) reported data from a Phase III trial in 125 children ages 2-18 with autism or neurogenetic diseases and insomnia showing that PedPRM melatonin met the primary endpoint...
07:00 , Oct 10, 2016 |  BC Week In Review  |  Clinical News

Piromelatine: Phase II started

Neurim began the double-blind, placebo-controlled, U.S. Phase II ReCOGNITION trial to evaluate 5, 20 and 50 mg oral piromelatine once daily for 26 weeks in about 500 patients treated with stable doses of acetylcholinesterase inhibitors....
08:00 , Feb 25, 2013 |  BC Week In Review  |  Clinical News

Piromelatine: Phase II data

Top-line data from a double-blind, U.S. Phase II trial in 120 patients with primary insomnia showed that once-daily 20 and 50 mg doses of piromelatine for 4 weeks each met the secondary endpoint of improving...
08:00 , Feb 4, 2013 |  BC Week In Review  |  Clinical News

Tasimelteon: Development discontinued

Vanda discontinued development of tasimelteon to treat MDD after the double-blind, U.S. Phase IIb/III MAGELLAN trial in 507 patients with MDD showed that once-daily 20 mg tasimelteon missed the primary endpoint of reducing HAMD-17 scores...
08:00 , Jan 28, 2013 |  BC Week In Review  |  Clinical News

Tasimelteon: Additional Phase III data

Data from patients who responded to tasimelteon in the open-label run-in portion of the double-blind, U.S. Phase III RESET trial showed that continued treatment with once-daily 20 mg oral tasimelteon met the primary endpoint of...
08:00 , Dec 24, 2012 |  BC Week In Review  |  Clinical News

Tasimelteon: Phase III data

The double-blind, U.S. and German Phase III SET trial in 84 blind patients with non-24-hour sleep wake disorder showed that once-daily 20 mg oral tasimelteon for 6 months met the co-primary endpoint of a greater...
08:00 , Jan 30, 2012 |  BC Week In Review  |  Clinical News

Tasimelteon: Preliminary Phase III data

Vanda said preliminary data from the run-in portion of the double-blind, U.S. Phase III RESET trial showed that once-daily 20 mg oral tasimelteon reset the body clock and aligned 4 blind patients with non-24-hour sleep...
08:00 , Nov 14, 2011 |  BC Week In Review  |  Clinical News

Tasimelteon: Phase IIb/III started

Vanda disclosed in its 3Q11 earnings that in September it began the double-blind, placebo-controlled, U.S. Phase IIb/III MAGELLAN trial to evaluate once-daily 20 mg tasimelteon for 8 weeks in about 500 patients. The trial includes...
08:00 , Nov 7, 2011 |  BC Week In Review  |  Clinical News

Valdoxan agomelatine: Development discontinued

Novartis disclosed in its 3Q11 earnings that it discontinued development of a sublingual formulation of AG0178 to treat MDD after 2 Phase III trials of the compound missed the primary endpoints. Details were not disclosed....