Zogenix, Inc., a pharmaceutical company specializing in drugs to treat pain and central nervous system disorders, outlined its plans fot develop  abuse-deterrent formulations of Zohydro 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 is developing two distinct approaches for abuse-deterrent formulations of Zohydro ER. Following a recent meeting with the US 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for Zohydro ER extended-release capsules in 2015 to include abuse deterrence claims consistent with the FDA’s current draft Guidance for Industry, Abuse-Deterrent Opioids – Evaluation and Labeling.

Zogenix also recently selected the final tablet formulation for clinical development in its collaboration with Altus Formulation. The  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 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.

Source: Zogenix