ARTICLE | Clinical News

Hydrocodone bitartrate regulatory update

March 31, 2014 7:00 AM UTC

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, extended-release (ER) formulation of hydrocodone approved to manage chronic pain severe enough to require a continuous, around-the-clock opioid analgesic when alternatives are inadequate. Patrick said the ban would last until FDA approves an abuse deterrent formulation. Zogenix said the ban "unfairly restricts patient access" and noted that most other opioids on the market are "both equal to or more potent than Zohydro ER" and available in higher strengths. Zogenix launched Zohydro in select pharmacies earlier this month.

Zogenix has been under fire for Zohydro at the federal level from legislators as well as patient groups, addiction centers and state attorneys general, who have called on FDA Commissioner Margaret Hamburg to reconsider the agency's approval of Zohydro or to set a rigorous timeline for the product to be reformulated to be abuse deterrent (see BioCentury, March 17). Last year, Zogenix partnered with Altus Formulation Inc. (Montreal, Quebec) to develop abuse-deterrent formulations of Zohydro. The company said it expects to launch abuse-deterrent formulations in 2016 (see BioCentury, Nov. 11, 2013). ...