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...
07:00 , Apr 15, 2013 |  BC Week In Review  |  Clinical News

Arbaclofen placarbil: Completed Phase III enrollment

XenoPort disclosed in its 4Q12 earnings that it completed enrollment in a double-blind, placebo-controlled, U.S. Phase III trial evaluating twice-daily 15, 30 and 45 mg arbaclofen placarbil for 13 weeks in about 200 patients. Patients...
07:00 , Aug 8, 2011 |  BC Week In Review  |  Clinical News

Arbaclofen placarbil: Phase III started

XenoPort disclosed in its 2Q11 earnings that it began a double-blind, placebo-controlled, U.S. Phase III trial to evaluate twice-daily 15, 30 and 45 mg arbaclofen placarbil for 13 weeks in about 200 patients. Patients will...
07:00 , May 2, 2011 |  BC Week In Review  |  Clinical News

Arbaclofen placarbil: SPA received

XenoPort received an SPA from FDA for a planned double-blind, placebo-controlled, U.S. Phase III trial to evaluate twice-daily 15, 30 and 45 mg arbaclofen placarbil for 13 weeks in about 200 patients. The Phase III...
07:00 , Mar 28, 2011 |  BC Week In Review  |  Clinical News

Arbaclofen placarbil: Preliminary Phase IIb data

XenoPort discontinued development of arbaclofen placarbil to treat GERD after top-line data from a double-blind, North American Phase IIb trial in 460 patients who remained symptomatic despite PPI treatment showed that all doses of the...
08:00 , Nov 15, 2010 |  BC Week In Review  |  Clinical News

Arbaclofen placarbil: Completed Phase IIb enrollment

XenoPort disclosed in its 3Q10 earnings that it completed enrollment of 425 patients in a double-blind, placebo-controlled, North American Phase IIb trial evaluating arbaclofen placarbil at doses of 20 or 30 mg twice daily or...
07:00 , Sep 20, 2010 |  BC Week In Review  |  Clinical News

Arbaclofen placarbil: Phase III start

After discussions with FDA, XenoPort said it plans to start a placebo-controlled Phase III trial and a long-term, open-label safety study of arbaclofen placarbil in 1H11. XenoPort said it hopes the studies will support the...
07:00 , Sep 20, 2010 |  BioCentury  |  Finance

Regulatory Milestones

Alkermes Inc. (NASDAQ:ALKS) was up $0.89 to $14.87 last week after FDA's Psychopharmacologic Drugs Advisory Committee voted 12-1 to recommend approval of an sNDA to extend the label of Vivitrol naltrexone to prevent relapse to...
00:47 , Sep 14, 2010 |  BC Extra  |  Clinical News

XenoPort up on arbaclofen placarbil plans

XenoPort Inc. (NASDAQ:XNPT) gained $1.35 (22%) to $7.55 on Monday after announcing plans to start Phase III testing in 1H11 for arbaclofen placarbil ( XP19986) to treat spasticity in multiple sclerosis (MS) patients. After discussions...