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New Data Shows Zohydro(R) ER Reduced Pain and Improved Function in People With Chronic Pain
Moderate and Substantial Levels of Pain Relief Produce the Greatest Functional Benefits With Zohydro(R) ER (hydrocodone bitartrate) Extended-Release Capsules, CII

PHOENIX, Sept. 18, 2014 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of pain-related and central nervous system (CNS) disorders, 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.

About Zohydro® ER

INDICATION

Zohydro® ER is an extended-release opioid agonist 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.

LIMITATIONS OF USE

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Zohydro ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Zohydro ER is not indicated as an as‑needed (prn) analgesic.

Please click here to see the Zohydro ER professional product labeling for the complete boxed warning and safety information.

WARNING: ADDICTION, ABUSE AND MISUSE;
LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION;
NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL;
and CYTOCHROME P450 3A4 INTERACTION

See full prescribing information for complete boxed warning.

  • Zohydro ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor regularly for development of these behaviors or conditions.
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow Zohydro ER whole to avoid exposure to a potentially fatal dose of hydrocodone.
  • Accidental ingestion of Zohydro ER, especially in children, can result in a fatal overdose of hydrocodone.
  • Prolonged use of Zohydro ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
  • Instruct patients not to consume alcohol or any products containing alcohol while taking Zohydro ER because co-ingestion can result in fatal plasma hydrocodone levels.
  • Initiation of CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of hydrocodone from Zohydro ER.

IMPORTANT SAFETY INFORMATION

Zohydro ER is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma; known or suspected paralytic ileus; and hypersensitivity to hydrocodone bitartrate.

Zohydro ER warnings for: interactions with CNS depressants; elderly, cachectic, debilitated patients, and those with chronic pulmonary disease; hypotensive effects; patients with head injury or increased intracranial pressure; and concomitant use of CYP3A4 may increase opioid effects. Please see full prescribing information for the complete warning information.

Potential serious adverse events caused by opioids include addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; interactions with other CNS depressants; hypotensive effects; gastrointestinal conditions, and seizures. The most common adverse reactions associated with Zohydro ER (≥2%) include constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, pruritus, abdominal pain, peripheral edema, upper respiratory tract infection, muscle spasms, urinary tract infection, back pain, and tremor.

About Zogenix

Zogenix, Inc. (Nasdaq:ZGNX) is a pharmaceutical company committed to developing and commercializing therapies that address specific clinical needs for people living with pain-related conditions and CNS disorders who need innovative treatment alternatives to help them return to normal daily functioning.

Forward-Looking Statements

Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "indicates," "will," "intends," "suggests," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding: the effectiveness of Zohydro ER, including the improvement in patients' functional outcomes and the ability to conduct normal life activities. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: the potential that the post-hoc analysis may not be predictive of future efficacy results of Zohydro ER; Zogenix's ability to achieve broad market acceptance and generate revenues from sales of Zohydro ER; the impact of pending "Paragraph IV" litigation concerning the filing of an Abbreviated New Drug Application for a potential generic version of Zohydro ER; Zogenix's reliance on its licensor to control enforcement proceedings for the Zohydro ER patents; and other risks detailed in Zogenix's prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Zohydro® ER is a registered mark of Zogenix, Inc.

FPR

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