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...
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 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....
07:00 , Oct 10, 2011 |  BC Week In Review  |  Clinical News

Rozerem ramelteon: Development discontinued

Takeda said its Takeda Global Research & Development (Europe) Ltd. subsidiary discontinued European development of ramelteon to treat insomnia "in order to best optimize Takeda's resources" for R&D. In 2008, Takeda withdrew an MAA for...
07:00 , Apr 28, 2011 |  BC Innovations  |  Distillery Therapeutics

Indication: Neurology

This week in therapeutics Indication Target/marker/pathway Summary Licensing status Publication and contact information Neurology Neurology Melatonin MT2 receptor (MTNR1B) In vitro and mouse studies suggest that...
07:00 , Sep 28, 2009 |  BC Week In Review  |  Clinical News

Valdoxan agomelatine: Phase III data

A double-blind, international Phase III trial in 515 patients showed that Valdoxan was superior to fluoxetine on the primary endpoint of mean change from baseline in HAM-D17 vs. placebo at 8 weeks (1.49 point difference,...