Zogenix Sues Massachusetts Over Painkiller Ban; Hearing Scheduled On April 14

(RTTNews) - Zogenix Inc. (ZGNX) said it presented its case in U.S. District Court in Boston requesting an immediate order staying the ban on the U.S. Food and Drug Administration or FDA-approved prescription drug product, Zohydro ER (hydrocodone bitartrate) extended-release capsules or CII, entered on March 27, 2014, by Massachusetts Governor Deval Patrick.

Zogenix said it appreciates the opportunity to be heard by the court on an expedited basis. A follow-up hearing has been scheduled for Monday, April 14, 2014.

Zogenix noted that it will continue to monitor, evaluate and take appropriate actions in all states specific to Zohydro ER to ensure that all FDA-approved Schedule II prescription opioids covered by the FDA mandated Risk Evaluation Mitigation Strategy (REMS) for extended-release and long-acting opioid analgesics receive equal treatment for any rules that impact patient access and prescribing.

Zohydro ER is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

On March 27, Patrick said that Department of Public Health will ban hydrocodone-only medication - a narcotic painkiller otherwise known as Zohydro. Zohydro is a dangerously addictive pharmaceutical painkiller, approved by the FDA recently over the objection of their scientific advisory council, and is not available in an abuse-deterrent form. Until it is available in an abuse-deterrent form, or better, until the Secretary of HHS or the Congress has acted on the requests to overturn the FDA, Zohydro will not be available in Massachusetts.

Patrick said, "DHP will mandate the use of prescription monitoring by physicians and pharmacies to better safeguard against over-prescribing to patients. This is currently a voluntary program. But we must have more rigor around the over-prescribing of pain medications that so often lead to addiction".

Patrick noted that DPH would dedicate an additional $20 million to expand the use and availability of prevention, intervention and treatment services to the general public, to the Department of Corrections and to Sheriffs' Departments.