07:00 , Oct 6, 2014 |  BC Week In Review  |  Clinical News

Zohydro ER hydrocodone bitartrate regulatory update

Zogenix submitted an sNDA to FDA for a capsule formulation of Zohydro ER hydrocodone bitartrate designed to deter abuse by injection or nasal administration. The company expects a decision by FDA in 1Q15. If the...
07:00 , Jul 14, 2014 |  BC Week In Review  |  Clinical News

Zohydro ER hydrocodone bitartrate regulatory update

Zogenix said it plans to submit an sNDA to FDA by October for a next-generation of pain drug Zohydro ER hydrocodone capsules designed to make it more difficult to abuse by injection or nasal administration....
07:00 , May 5, 2014 |  BC Week In Review  |  Clinical News

Hydrocodone bitartrate ER: Phase III data

Top-line data from the double-blind, U.S. Phase III Study 3103 in about 623 patients with moderate to severe chronic low back pain showed that CEP-33237 met the primary endpoint of maintaining the improvement in weekly...
07:00 , May 5, 2014 |  BC Week In Review  |  Clinical News

Hydrocodone bitartrate ER: Clinical trial data

A double-blind, crossover trial in 35 healthy, non-dependent recreational opioid drug users showed that Purdue's abuse-deterrent, once-daily hydrocodone bitartrate ER when given either intact or chewed met the primary endpoint of lower drug liking scores...
07:00 , Apr 28, 2014 |  BC Week In Review  |  Company News

Zogenix neurology news

Massachusetts Gov. Deval Patrick said doctors are now required to check a patient's controlled-substance history through a statewide prescription monitoring program (PMP) prior to prescribing Zogenix's Zohydro ER hydrocodone bitartrate for pain drug. The program...
07:00 , Apr 21, 2014 |  BC Week In Review  |  Company News

Zogenix neurology news

A judge in the U.S. District Court for the District of Massachusetts granted Zogenix's motion for a preliminary injunction thus stopping Massachusetts' statewide ban on Zogenix's pain drug Zohydro ER hydrocodone bitartrate. Zogenix said the...
07:00 , Apr 14, 2014 |  BC Week In Review  |  Company News

Alkermes, Zogenix neurology news

Zogenix filed suit challenging Massachusetts Gov. Deval Patrick's executive order banning the prescription or distribution of pain drug Zohydro ER hydrocodone bitartrate. Zogenix filed the suit against Patrick and Cheryl Bartlett, commissioner of the Massachusetts...
07:00 , Mar 31, 2014 |  BC Week In Review  |  Clinical News

Hydrocodone bitartrate regulatory update

Massachusetts Gov. Deval Patrick declared opiate addiction a public health emergency and directed state authorities to immediately prohibit the prescription or sale of Zogenix's pain drug, Zohydro ER hydrocodone bitartrate. Zohydro is an oral, non-abuse-deterrent,...
07:00 , Mar 17, 2014 |  BC Week In Review  |  Clinical News

Hydrocodone bitartrate ER: Phase III data

Top-line data from a double-blind, U.S. Phase III trial in 588 opioidnaive and opioid-experienced patients with moderate to severe chronic low back pain showed that once-daily hydrocodone bitartrate ER met the primary endpoint of reducing...
01:02 , Mar 13, 2014 |  BC Extra  |  Clinical News

Purdue reports data for abuse-deterrent ER hydrocodone

Purdue Pharma L.P. (Stamford, Conn.) said its once-daily hydrocodone bitartrate ER met the primary endpoint of reducing mean pain intensity over a 24-hour period recorded daily during week 12 from baseline vs. placebo in a...