Zogenix (ZGNX) Gains; New Data Shows Zohydro ER Reduces Pain
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Zogenix, Inc. (Nasdaq: ZGNX) today presented data from a one year open label study that demonstrated chronic pain patients who achieved substantial levels of pain reduction with Zohydro® ER, (hydrocodone bitartrate) Extended-Release Capsules, CII experienced a statistically significant (p≤0.001) improvement in functional outcomes from baseline to end of study. These findings will be presented at American Academy of Pain Management's (AAPM) 25th Annual Clinical Meeting taking place Sept. 18-21 in Phoenix, Arizona.
"For some people, chronic pain can be so debilitating that they have difficulty conducting normal daily activities, such as standing, walking and sleeping, and this can greatly impact the quality of life of not only those experiencing the pain, but also their family or caregivers. We need treatment options that relieve pain and also result in meaningful improvements in patient function," said Charles Argoff, M.D., Professor of Neurology, Albany Medical College. "This post-hoc analysis showed that approximately 44% of patients taking Zohydro ER achieved a level of pain relief that was also associated with a significant improvement in their ability to, once again, conduct normal life activities."
Other analyses in this study showed that patients that reported ≥50% pain reduction also reported a 1.5 to 4.5-fold greater in magnitude improvement in functional outcomes. Knowing which levels of pain relief are associated with the greatest functional outcomes allows clinicians to set targets with their patients for determining the success of a given intervention.
"We are committed to helping people living with chronic pain return to normal, daily lives, and these findings demonstrate that Zohydro ER taken every 12 hours provided meaningful pain relief that resulted in significant functional outcomes for most patients and was generally well-tolerated," said Stephen Farr, Ph.D., President of Zogenix. "These data add to the growing body of evidence supporting the benefits of Zohydro ER for severe chronic pain patients."
About the Functional Improvement Study
Hydrocodone-ER in chronic pain: association of pain intensity improvement with functional outcomes"
Poster 34, Friday, September 17, 3:30 pm - 4:30 pm
Data from a Phase 3 open label safety study were analyzed to assess various levels of pain relief observed with Zohydro ER in subjects with chronic pain and the association of these levels of pain reduction with secondary functional outcomes. The study started with a conversion/titration phase in which subjects (n=638) were converted to individualized doses of Zohydro ER every 12 hours, followed by a 48-week maintenance phase (n=424). Hospital Anxiety and Depression Scale (HADS), Oswestry Disability Inventory (ODI), Quebec Back Pain Disability Scale, and Subject Global Assessment of Medication (SGAM) scores were taken at screening, the end of the six-week conversion/titration period, and at the end of the study. Average pain was similarly assessed using an 11-point numeric rating scale.
Key findings from the post-hoc analysis include:
Clinically meaningful and substantial levels of pain relief (30% to <50% and ≥50%, respectively) were associated with the greatest improvements in function, pain interference and other secondary outcomes, with greater improvements seen in subjects reporting substantial pain relief
- Approximately 44% of patients with substantial levels of pain relief (≥50%) experienced 2 to 4 times greater improvement in functional outcomes and global assessment as compared to other groups
- Approximately 60% of patients experienced moderate to substantial levels of pain relief
These results suggest that a simple assessment of change in pain scores in individual patients can be used to predict functional improvement, and therefore the ultimate success of treatment
Zohydro ER is the first and only extended-release hydrocodone for around-the clock management of severe chronic pain without acetaminophen, lowering the risk for liver toxicity due to overexposure of acetaminophen, which can be fatal or require a liver transplant.
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