New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
April 8, 2014
07:04 EDTALKSAlkermes announces phase 3 'positive' results from aripiprazole lauroxil study
Alkermes announced "positive" topline results from a randomized, double-blind, placebo-controlled phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia. Patients treated once monthly with either 441 mg or 882 mg of aripiprazole lauroxil demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scale total scores at week 12, compared to placebo, which was the prespecified primary endpoint in the study. Based on the positive results from this phase 3 study, Alkermes plans to submit a New Drug Application to the U.S. Food and Drug Administration in 3Q14. In addition to meeting the prespecified primary efficacy endpoint, the study also met the prespecified key secondary endpoint of improvement on the Clinical Global Impression-Improvement scale versus placebo at week 12. Aripiprazole lauroxil was generally well tolerated in the phase 3 study, and the safety profile of aripiprazole lauroxil was similar to that reported with oral aripiprazole. The most common adverse events in the study were insomnia, akathisia and headache. Alkermes will present data from the phase 3 study at an upcoming medical meeting and submit the results for publication in a peer-reviewed journal.
News For ALKS From The Last 14 Days
Check below for free stories on ALKS the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
July 17, 2014
07:05 EDTALKSAlkermes announces initiation of Phase 1 study of ALKS 8700 for treatment of MS
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use