02:31 , May 18, 2018 |  BC Week In Review  |  Clinical News

FDA approves US WorldMeds' Lucemyra for opioid withdrawal

FDA approved Lucemyra lofexidine from US WorldMeds LLC (Louisville, Ky.) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. According to the agency, Lucemyra is the first non-opioid drug approved...
23:41 , May 16, 2018 |  BC Extra  |  Company News

FDA approves US WorldMeds' Lucemyra for opioid withdrawal

FDA approved Lucemyra lofexidine from US WorldMeds LLC (Louisville, Ky.) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. According to the agency, Lucemyra is the first non-opioid drug approved...
21:06 , Apr 6, 2018 |  BioCentury  |  Finance

Smid-cap smorgasbord

While the biggest milestone of the second quarter came early and turned out to be a disappointment, investors still have plenty to look forward to in immuno-oncology. In addition, specialist investors’ current strategy of overweighting...
17:16 , Mar 30, 2018 |  BC Week In Review  |  Clinical News

FDA panel backs US WorldMeds' opioid withdrawal candidate

US WorldMeds LLC (Louisville, Ky.) said FDA's Psychopharmacologic Drugs Advisory Committee voted 11-1 to recommend approval of an NDA for lofexidine to reduce symptoms associated with opioid withdrawal and facilitation of completion of opioid discontinuation...
18:37 , Mar 9, 2018 |  BC Week In Review  |  Clinical News

FDA panel to review US WorldMeds' opioid withdrawal candidate

FDA said its Psychopharmacologic Drugs Advisory Committee will meet on March 27 to discuss an NDA from US WorldMeds LLC (Lousiville, Ky.) for lofexidine to reduce symptoms associated with opioid withdrawal and facilitation of completion...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to a...
21:46 , Dec 1, 2017 |  BC Week In Review  |  Company News

FDA reviewing US WorldMeds’ opioid withdrawal candidate

FDA accepted and granted Priority Review to an NDA for lofexidine from US WorldMeds LLC (Louisville, Ky.) to mitigate symptoms associated with opioid withdrawal. Its PDUFA date is in 2Q18. Lofexidine is an agonist of adrenergic...
20:37 , Nov 21, 2017 |  BC Extra  |  Company News

FDA reviewing US WorldMeds’ opioid withdrawal candidate

FDA accepted and granted Priority Review to an NDA for lofexidine from US WorldMeds LLC (Louisville, Ky.) to mitigate symptoms associated with opioid withdrawal. Its PDUFA date is in 2Q18. Lofexidine is an agonist of adrenergic...
07:00 , Jun 23, 2008 |  BC Week In Review  |  Clinical News

BritLofex lofexidine: Phase III data

Top-line data from a double-blind, U.S. Phase III trial showed that lofexidine met the primary endpoint of a significant reduction in withdrawal symptoms at day 3 compared with placebo. US WorldMeds said day 3 is...
07:00 , Oct 16, 2006 |  BC Week In Review  |  Clinical News

BritLofex lofexidine: Phase III started

WorldMeds began the double-blind, placebo-controlled, U.S. Phase III USWM-001 trial in 264 opiate-dependent patients. In November 2003, WorldMeds received U.S. rights to the compound from Britannia, who markets the compound under the name BritLofex to...