07:00 , Aug 22, 2016 |  BC Week In Review  |  Clinical News

Clonidine topical gel: Completed Phase IIb enrollment

BioDelivery completed enrollment of 125 patients in a double-blind, placebo-controlled, U.S. Phase IIb trial evaluating clonidine topical gel applied thrice daily for 12 weeks. BioDelivery has exclusive, worldwide rights from Arcion to develop and commercialize...
07:00 , Apr 6, 2015 |  BC Week In Review  |  Clinical News

Clonidine: Phase III data

The double-blind, U.S. Phase III RHAPSODY trial in about 260 patients with painful diabetic neuropathy showed that clonidine topical gel missed the primary endpoint of improving average NPRS score from baseline to day 84 vs....
07:00 , Apr 6, 2015 |  BioCentury  |  Finance

Up, up and acquired

For the first time since 1Q14, none of the biotech market cap segments fell. While the $200-$499 million tier treaded water, all other segments finished in the black, led by the $1-$4.9 billion segment. Large...
01:06 , Mar 31, 2015 |  BC Extra  |  Clinical News

BioDelivery falls on Phase III miss

BioDelivery Sciences International Inc. (NASDAQ:BDSI) shed $3.38 (24%) to $10.51 on Monday after its clonidine topical gel ( ARC-4558 ) missed the primary endpoint in a Phase III trial to treat painful diabetic neuropathy (PDN)....
07:00 , Aug 18, 2014 |  BC Week In Review  |  Clinical News

Clonidine: Phase III amended

BioDelivery Sciences said it will enroll an additional 80 patients in the double-blind, U.S. Phase III RHAPSODY trial to maintain 90% power to detect a statistically significant difference between its clonidine topical gel and placebo....
07:00 , Jul 21, 2014 |  BC Week In Review  |  Clinical News

Clonidine: Completed Phase III enrollment

BioDelivery Sciences completed enrollment of 140 patients with functional skin nociceptors in the double-blind, placebo-controlled, U.S. Phase III RHAPSODY trial evaluating clonidine topical gel for 12 weeks. The company expects to complete an interim analysis...
07:00 , Apr 14, 2014 |  BC Week In Review  |  Clinical News

Clonidine: Phase III started

BioDelivery Sciences began the double-blind, placebo-controlled, U.S. Phase III RHAPSODY trial to evaluate clonidine topical gel in about 140 patients demonstrating functional skin nociceptors. Clonidine topical gel has Fast Track designation from FDA for the...
08:00 , Dec 9, 2013 |  BC Week In Review  |  Clinical News

Clonidine: Phase III start

Next quarter, BioDelivery will begin a placebo-controlled Phase III trial of clonidine topical gel . BioDelivery is developing the product under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference...
07:00 , Apr 1, 2013 |  BC Week In Review  |  Company News

Arcion, BioDelivery deal

Arcion granted BioDelivery exclusive, worldwide rights to develop and commercialize topical clonidine gel (formerly ARC-4558 ). Arcion will receive $2 million in BioDelivery common stock up front and is eligible to receive $2.5 million in...
07:00 , Sep 20, 2010 |  BC Week In Review  |  Clinical News

Clonidine regulatory update

FDA granted Fast Track designation to Arcion's ARC-4558 to treat pain associated with painful diabetic neuropathy. The company plans to start Phase III testing of the 0.1% gel formulation of clonidine in 1Q11. Arcion Therapeutics...