Zogenix Provides Update On Development Of Abuse Deterrent Formulations Of Zohydro ER

Zogenix, Inc. ZGNX today announced an update on its development programs focused on the introduction of abuse deterrent formulations of Zohydro(R) ER (hydrocodone bitartrate) Extended-Release Capsules, CII. Zohydro ER is 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. The company has previously indicated that it is simultaneously developing two distinct approaches for abuse deterrent formulations of Zohydro ER. Following a recent meeting with the U.S. Food and Drug Administration (FDA), Zogenix expects to file a supplemental new drug application (sNDA) by October 2014 for a next-generation formulation of Zohydro ER Extended-Release Capsules designed to make it more difficult to abuse by injection or nasal administration. If approved, this new formulation could be available to prescribers in early 2015. The company will continue to characterize the product's abuse deterrent properties with the goal of further amending the labeling for Zohydro ER Extended-Release Capsules in 2015 to include abuse deterrence claims consistent with the FDA's current draft Guidance for Industry, Abuse-Deterrent Opioids -- Evaluation and Labeling. As of today, only one of more than thirty extended-release/long-acting opioid analgesics has abuse deterrent properties described in FDA-approved labeling for making abuse via injection more difficult and reducing abuse via the nasal route based on the draft Guidance for Industry. Zogenix also recently selected the final tablet formulation for clinical development in its collaboration with Altus Formulation. Like the next-generation formulation, this proprietary tablet technology is designed to meet FDA's stated goal of encouraging scientific and clinical research that will advance the development of abuse deterrent technologies to address opioid medication misuse and abuse. The innovative tablet formulation of Zohydro ER incorporates multiple features to maintain the extended-release property of the medication when crushed or chewed, reducing one of the ways in which opioids are abused through oral ingestion, as well other features to address abuse by injection or nasal administration. The company is targeting a new drug application (NDA) submission for this tablet formulation during the first half of 2016, which will reference the approved NDA for Zohydro ER with respect to previous findings of safety and efficacy. The tablet formulation is designed to have the same hydrocodone release profile as the currently approved capsule formulation of Zohydro ER when used as intended, greatly simplifying its development program. "We believe we have two strong technology options to deter misuse and abuse without affecting the established safety and efficacy profile of Zohydro ER, and look forward to submitting our data to the FDA with the goal of bringing these new options to patients," said Stephen Farr, Ph.D., President of Zogenix. "This dual approach will allow us to potentially launch our next generation of Zohydro ER Extended-Release Capsules in early 2015, followed by the tablet formulation with advanced proprietary abuse deterrent technology in 2016. We also continue to take part in comprehensive and collaborative efforts with prescribers, pharmacists and government officials to help ensure appropriate patients have access to the medications that will best support the management of their severe chronic pain." In addition to working with FDA to integrate abuse deterrent properties into Zohydro ER, Zogenix strongly supports more comprehensive approaches to addressing the public health challenge of prescription drug abuse. Zogenix has taken extraordinary steps to support the appropriate use of Zohydro ER through a voluntary set of educational tools and safeguards to augment the FDA industry mandated class-wide Risk Evaluation Mitigation Strategy (REMS) for extended-release opioids. The company has implemented novel initiatives, such as providing Zohydro ER patients free locking pill bottle caps and discounts for safe-storage units to help prevent other people from gaining access to their medications. Prior to the availability of Zohydro ER, Zogenix established an independent External Safe Use Board to assess and make recommendations on surveillance programs and data collection related to misuse and diversion of the product. Approved by the FDA in October 2013, Zohydro ER provides a potential solution to patients who could benefit from an extended-release hydrocodone for around-the clock management of severe chronic pain and who may be at risk for liver damage due to overexposure of acetaminophen, which can be fatal or require a liver transplant.