Zogenix Submits Modified Formulation of Zohydro(R) ER With Potential Abuse Deterrent Properties for FDA Review
Zohydro ER is 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.
"The new technology being added to Zohydro ER represents a meaningful advancement because it incorporates properties designed to deter abuse yet maintain the efficacy of the medication, a central consideration throughout the product's development," said
Farr added: "While we are pleased to have advanced the new formulation to submission of a sNDA, this represents only one element of the comprehensive approach
Keeping prescription medicines out of the hands of those who would abuse them is critical to any strategy aimed at stopping diversion, misuse and abuse. With this in mind,
Approved by the
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 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.
Zohydro® ER is a registered mark of
Zack Kubow|The Ruth Group 646.536.7020 | email@example.com Media David Polk| Chandler Chicco Companies 310.309.1029 | DPolk@chandlerchiccocompanies.com