18:37 , Mar 9, 2018 |  BC Week In Review  |  Clinical News

Jazz gets PDUFA date for excessive sleepiness candidate

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) said FDA accepted for review an NDA for solriamfetol (JZP-110) to treat excessive sleepiness associated with narcolepsy or obstructive sleep apnea. The PDUFA date is Dec. 20. Solriamfetol is a phenylalanine...
20:15 , Feb 16, 2017 |  BC Week In Review  |  Clinical News

JZP-110: Ph II started

Jazz began a 4-week, double-blind, placebo-controlled, crossover, U.S. Phase II trial to evaluate 75, 150 and 300 mg doses of oral JZP-110 in about 50 PD patients. Top-line data from a pair of Phase III...
22:30 , Dec 7, 2016 |  BC Week In Review  |  Clinical News

JZP-110: Completed Ph III 14-002 enrollment

Jazz completed enrollment of 240 patients in the double-blind, placebo-controlled, North American Phase III Study 14-002 evaluating 75, 150 and 300 mg oral JZP-110 once daily for 12 weeks. Patients may be eligible to enroll...
07:00 , Oct 10, 2016 |  BC Week In Review  |  Clinical News

JZP-110: Completed Phase III enrollment

Jazz completed enrollment of about 200 patients in the double-blind, placebo-controlled Phase II 14-004 trial evaluating 75, 150 and 300 mg oral JZP-110 once daily for 4 weeks followed by a double-blind, 2-week withdrawal portion....
07:00 , Oct 10, 2016 |  BC Week In Review  |  Clinical News

JZP-110: Completed Phase III enrollment

Jazz completed enrollment of about 440 patients in the double-blind, placebo-controlled Phase II 14-003 trial evaluating 37.5, 75, 150 and 300 mg oral JZP-110 once daily. In 2014, Jazz purchased from Aerial BioPharma LLC (Morrisville,...
00:08 , May 26, 2016 |  BC Extra  |  Financial News

Arrivo debuts with $49M

Newco Arrivo BioVentures LLC (Research Triangle Park, N.C.) launched with a $49 million venture round led by Jazz Pharmaceuticals plc (NASDAQ:JAZZ). Solas BioVentures, Rex Health Ventures and undisclosed others also participated. Arrivo plans to acquire...
07:00 , Jun 29, 2015 |  BC Week In Review  |  Clinical News

JZP-110: Phase III started

Jazz began the double-blind, placebo-controlled, North American Phase III Study 14-003 to evaluate 37.5, 75, 150 and 300 mg oral JZP-110 once daily for 12 weeks in about 440 patients. Patients may be eligible to...
07:00 , Jun 29, 2015 |  BC Week In Review  |  Clinical News

JZP-110: Phase III started

Jazz began the 6-week, double-blind, placebo-controlled, U.S. Phase III Study 14-004 to evaluate 75, 150 and 300 mg oral JZP-110 once daily in about 200 patients. In 2014, Jazz purchased from Aerial BioPharma LLC (Morrisville,...
07:00 , Jun 29, 2015 |  BC Week In Review  |  Clinical News

JZP-110: Phase III started

Jazz began the double-blind, placebo-controlled, North American Phase III Study 14-002 to evaluate 75, 150 and 300 mg oral JZP-110 for 12 weeks in about 240 adult patients. Patients may be eligible to enroll in...
07:00 , Jul 21, 2014 |  BC Week In Review  |  Clinical News

JZP-110: Phase IIb data

A double-blind, U.S. Phase IIb trial in 93 patients with narcolepsy showed that once-daily JZP-110 met the co-primary endpoints of increasing average sleep onset latency as measured by MWT (12.8 vs. 2.1 minutes, p<0.0001) and...