SAN DIEGO, Dec. 1, 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 announced the publication of a long-term Phase 3 open-label study, which showed that Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, were generally safe, well-tolerated and effective in treating chronic pain for up to one year. The complete findings were published in the November 2014 issue of the Journal of Pain Research (available online here).
The safety and tolerability profile of Zohydro ER observed in this study was consistent with the Phase 3 pivotal efficacy study of Zohydro ER and is comparable with other opioid analgesics. The most common adverse events (AEs) observed during the 48-week maintenance phase were constipation (12.5%), back pain (11.1%), nausea (9.9%), and vomiting (9.7%). Effectiveness, a secondary endpoint, showed the majority (55%) of subjects treated with Zohydro ER dosed every 12 hours for up to one year had a clinically meaningful improvement in pain scores (≥ 30% reduction in average daily pain intensity). Secondary outcomes also demonstrated improvements in function, depression, and anxiety assessments.
"People living with severe, chronic pain need effective medications that have demonstrated safety profiles over extended periods of time," said Srinivas Nalamachu, MD, president and medical director, International Clinical Research Institute, Overland Park, Kansas and lead author of the publication. "This study, designed to mimic typical clinical practice, reinforces that Zohydro ER provides a safe and effective treatment option for patients experiencing chronic pain, especially those who are taking immediate-release hydrocodone around the clock and have concerns about liver toxicity due to acetaminophen."
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. Zohydro ER was developed to reduce the number of hydrocodone doses per day and to eliminate acetaminophen, an added ingredient in immediate-release hydrocodone combination products, which can put patients at risk for liver toxicity when taken chronically and at high doses.
"In addition to needing options for chronic pain patients who are at risk for acetaminophen toxicity, prescribers may need to switch opioids if their patient's current opioid treatment becomes inadequate either due to loss of pain relief or increasing side effects," said Bradley Galer, MD, chief medical officer of Zogenix. "That's why it's so important that physicians and their patients living with severe chronic pain have access to a full range of treatment options."
About the Long-Term Safety Study
This one-year, open-label multicenter study started with a conversion/titration phase of ≤6 weeks 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). Safety and tolerability, the primary objective, and long-term effectiveness (as measured by change in average pain score; 0=no pain, 10=worst pain imaginable), the secondary objective, were monitored throughout the study. Depression, anxiety and function were also assessed during the study and reported as secondary outcomes.
About Zohydro® ER
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 see the Zohydro ER full prescribing information 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.
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.
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 functioning. 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: Zogenix's ability to achieve broad market acceptance and generate revenues from sales of Zohydro ER; the potential that the analysis may not be predictive of future efficacy results of Zohydro ER; 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.