Zogenix announced that it has submitted a New Drug Application (NDA) to the FDA for Zohydro (hydrocodone bitartrate extended-release capsules), an investigational product candidate for the treatment of chronic pain.
The NDA submission is based on data from over 1,100 patients with chronic pain participating in the pivotal Phase 3 efficacy study (Study 801), and an open-label Phase 3 safety study (Study 802) of Zohydro. Study 801 successfully met its primary efficacy endpoint, demonstrating that Zohydro resulted in significantly (P=0.008) improved chronic pain relief compared to placebo. The two key secondary endpoints in this study – the proportion of patients with at least 30% improvement in pain intensity and the improvement of overall satisfaction of medication – were also met. Additional study endpoints were supportive of the efficacy of Zohydro compared to placebo. The study demonstrated that Zohydro was generally safe and well tolerated.
Zohydro is a novel, oral, single-entity extended-release formulation of hydrocodone (an opioid) without acetaminophen for the management of moderate to severe chronic pain in patients requiring around the clock opioid therapy. If approved, Zohydro could be the first single-entity hydrocodone therapy, avoiding the potential for liver injury associated with the use of acetaminophen in high doses or over long periods of time. Zohydro uses patented Spheroidal Oral Drug Absorption System (SODAS) drug delivery technology which serves to enhance the release profile of hydrocodone to provide extended-release pain relief relative to existing immediate-release combination products.
For more information visit www.zogenix.com.