00:17 , May 19, 2017 |  BC Week In Review  |  Clinical News

Jazz's Xyrem meets in Phase II/III for pediatric narcolepsy with cataplexy

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) reported top-line data from the double-blind, international Phase II/III EXPRESS trial in 106 patients ages 7-17 with narcolepsy with cataplexy showing that nightly oral Xyrem sodium oxybate (JZP-6) met the primary...
19:15 , Apr 6, 2017 |  BC Extra  |  Company News

Jazz, Hikma settle Xyrem patent litigation

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) granted Hikma Pharmaceuticals plc (LSE:HIK) rights to market an authorized generic version of narcolepsy drug Xyrem sodium oxybate starting on Jan. 1, 2023. The agreement settles patent litigation between Jazz and...
20:51 , Mar 23, 2017 |  BC Week In Review  |  Clinical News

JZP-258: Ph III started

Jazz began a double-blind, placebo-controlled, international Phase III trial to evaluate JZP-258 in about 130 patients. Jazz Pharmaceuticals plc (NASDAQ:JAZZ), Dublin, Ireland  Product: JZP-258  Business: Neurology  Molecular target: GABA B receptor  Description: Oral solution containing mixture of oxybate salts  Indication: Treat...
21:52 , Feb 9, 2017 |  BC Week In Review  |  Clinical News

Xyrem regulatory update

FDA approved an ANDA from the West-Ward Pharmaceuticals Corp. subsidiary of Hikma Pharmaceuticals plc (LSE:HIK, London, U.K.) for a generic version of Xyrem sodium oxybate to treat cataplexy and excessive daytime sleepiness in patients with...
21:32 , Jan 20, 2017 |  BC Week In Review  |  Clinical News

PXT864: PLEODIAL-II extension study data

Data from 37 patients with mild AD in the open-label PLEODIAL-II extension of the single-blind, French Phase II PLEODIAL-I trial showed that twice-daily low-, mid- and high-dose oral PXT864 increased mean ADAS-Cog scores from baseline...
07:00 , Oct 5, 2015 |  BC Week In Review  |  Clinical News

Arbaclofen regulatory update

FDA accepted for review an NDA from Osmotica for Ontinua ER arbaclofen to treat spasticity in patients with multiple sclerosis (MS). Osmotica declined to disclose the PDUFA date. The product is an extended-release tablet of...
08:00 , Feb 5, 2015 |  BC Innovations  |  Product R&D

Addex's allosterics

Allosteric modulators are slowly filling the clinical pipeline, but finding the right assays to discover and characterize them properly still confounds companies in the space. Addex Therapeutics Ltd. is going back to basics and forging...
07:00 , Aug 11, 2014 |  BC Week In Review  |  Clinical News

Addex preclinical data

In nicotine-dependent mice, 1, 3 and 10 mg/kg oral ADX71441 administered 60 minutes prior to mecamylamine dose-dependently reversed somatic withdrawal signs. The 10 mg/kg dose of ADX71441 also reversed hyperalgesia. The data were generated as...
07:00 , Jun 2, 2014 |  BC Week In Review  |  Company News

Reckitt Benckiser, XenoPort deal

XenoPort granted Reckitt an exclusive, worldwide license to develop and commercialize arbaclofen placarbil ( XP19986). XenoPort will have certain rights to negotiate with Reckitt on collaborations for non-addiction indications. Reckitt plans to begin a Phase...
07:00 , May 27, 2013 |  BC Week In Review  |  Clinical News

Arbaclofen placarbil: Development discontinued

Xenoport discontinued development of arbaclofen placarbil after top-line data from a 13-week, double-blind, U.S. Phase III trial in 228 patients with spasticity due to MS showed that the product missed the co-primary endpoints of improving...