Zogenix Receives FDA Approval for Zohydro(TM) ER (hydrocodone bitartrate) Extended-Release Capsules
Zohydro ER is the first extended-release formulation hydrocodone therapy without acetaminophen. The use of products containing acetaminophen in high doses over long periods of time has the potential for causing liver injury. Acetaminophen overdose is a leading cause of acute liver failure in
"Zohydro ER fulfills a critical need among people living with chronic pain who meet the criteria for therapy with extended release opioids. It is the first extended-release hydrocodone medicine that is acetaminophen-free. Also, a significant proportion of patients on existing forms of immediate-release hydrocodone-acetaminophen combination treatments have liver disease or risk factors, and the availability of an acetaminophen-free formulation encompassing a range of hydrocodone doses is an important therapeutic option for these patients," said Dr.
"In addition to the REMS,
Zohydro ER capsules will be available in six dosage strengths ranging from 10 mg to 50 mg with dosing every 12 hours. Zohydro ER is classified as a
Zohydro ER was studied in over 1,100 people living with chronic pain who participated in the pivotal Phase 3 efficacy study or an open-label Phase 3 long-term safety study. The efficacy study that enrolled over 500 subjects with chronic low back pain met the primary endpoint in demonstrating that treatment with Zohydro ER resulted in significantly improved chronic pain relief compared to placebo. The key secondary endpoint was also achieved: a significantly higher number of subjects experienced at least 30% improvement in pain intensity from screening to end of study (67.5%, Zohydro ER versus 31.1%, placebo). The safety profile of Zohydro ER in both Phase 3 studies was consistent with other opioids in that the most frequent treatment emergent adverse events were constipation, nausea, drowsiness (somnolence), fatigue, headache, dizziness, dry mouth, vomiting and itching (pruritus).
Zohydro ER uses
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Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, the Company's commercial activities relating to Zohydro ER and SUMAVEL DosePro, the Company's financial status and any comments the Company may make about its future plans or prospects in response to questions from participants on the conference call.
About the voluntary safe use initiatives for Zohydro ER
To support the appropriate use of Zohydro ER,
- Integrated broad-ranging educational resources for patients, physicians and pharmacists, that complement and build upon the ER/LA opioid analgesics REMS, including assessment tools and case-based simulated training
- Ongoing surveillance and monitoring of key measures from the date of launch which are intended to detect potential misuse, abuse and diversion of Zohydro ER
- Commercial activity focused on selected physicians who are experienced in the prescribing of Schedule II extended-release opioids, as well as proactive medical outreach to those who have expressed an interest in prescribing Zohydro ER
Zogenixterritory representatives of completion of education and training on all REMS and voluntary safe use initiatives for Zohydro ER
Incentive compensation based exclusively on achieving safe use goals rather than prescription sales volume for
Zogenixterritory representatives throughout the launch year
- Distribution of safe storage mechanisms to encourage patients to practice at-home safekeeping of their prescribed quantity of Zohydro ER
About Zohydro ER
Zohydro™ ER is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate 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 for use 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 EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME and INTERACTION WITH ALCOHOL
- 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 consumption of Zohydro ER, especially in children, can result in fatal overdose of hydrocodone.
- For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome. Prolonged use during pregnancy can result in life-threatening neonatal opioid withdrawal syndrome.
- 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.
IMPORTANT SAFETY INFORMATION
Zohydro ER is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma or hypercarbia; known or suspected paralytic ileus; and hypersensitivity to hydrocodone bitartrate or any other ingredients in Zohydro ER.
Zohydro ER contains hydrocodone, a Schedule II controlled substance. As an opioid, Zohydro ER exposes users to the risks of addiction, abuse, and misuse. As modified-release products, such as Zohydro ER, deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present.
Potential serious adverse events caused by opioids include respiratory depression, potential for misuse and abuse, CNS depressant effects, prolonged gastric obstruction, and severe hypotension. 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.
ZohydroTM ER is a trademark and SUMAVEL® and DosePro® are registered trademarks of
SODAS® is a trademark of
1 Michna, E, Duh, MS, Korves, C, Dahl, JL. Removal of opioid/acetaminophen combination prescription pain medications: assessing the evidence for hepatotoxicity and consequences of removal of these medications. Pain Medicine. 2010; 11: 369-378.
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