Zogenix, Inc. Home Careers Where MEDICINE Meets TECHNOLOGY About Zogenix Responsibility Products Pipeline Technology Newsroom Investors Contact RESPONSIBILITY Latest Entries: Now Is the Time for Collaboration on a Comprehensive Approach to Address Nation’s Opioid Abuse Epidemic Voices of the Patient: Christopher Phillips Voices of the Patient: Mark Maginn Voices of the Patient: Gina Libby Voices of the Patient: Angelika Byczkowski Voices of the Patient: Elizabeth Schenk Multidisciplinary Chronic Pain Community Expert Roundtable - Discussion Highlights Chronic Pain Community Expert Roundtable - Discussion Highlights Stop it Before it Starts: A Unique Approach to Reducing Prescription Drug Abuse Pain Community Recognizes Zogenix’s Marsha Stanton, as TPC Hero of the Month Drug Take-Back Day Every Day: A Program to Help Prevent Prescription Abuse The Appropriate Patient for Zohydro™ ER The New England Journal of Medicine: We Must Collectively Strive for Balance between Chronic Pain and Addiction Let's Get the Facts Straight About Zohydro™ ER (hydrocodone bitartrate) Extended-Release Capsules, CII Zogenix Files Amended Complaint Against Continued Massachusetts Restrictions on Zohydro™ ER FDA, HHS Reaffirm Support for Chronic Pain Patients Amid Zohydro ER Debate Let's Get the Facts Straight About Zohydro ER Massachusetts Denies Patients a Legitimate Option for Severe Chronic Pain Message from Zogenix CEO Roger Hawley to Stakeholders FDA Commissioner Hamburg Reiterates the Necessity of Zohydro ER Our commitment to responsibly manage, distribute and commercialize Zohydro ER External Viewpoints: July 2014 The Forgotten Patients: Those Who Benefit From Opioid Treatment July 1, 2014 CDC Report on Opioid Prescribing Trends in the U.S. (PDF) June 26, 2014 ASPMN Statement Regarding Misuse and Abuse of Opioids May 8, 2014 Zohydro and a New Obstacle to Medical Innovation April 29, 2014 The way forward on opioid abuse: A call to action for science-based, comprehensive strategies (by Margaret Hamburg, M.D.) April 23, 2014 Chronic Pain, Addiction, and Zohydro April 22, 2014 Massachusetts Pain Initiative Statement on Zohydro ER April 20, 2014 FDA Commissioner Hamburg addresses misperceptions and the attempted bans of Zohydro ER April 16, 2014 FDA wants new safety measures on all long-acting opioids April 14, 2014 American Academy of Pain Management restatement on extended-release hydrocodone Let's Get the Facts Straight About Zohydro ER We are extremely disappointed that the U.S. Drug Enforcement Administration (DEA) Administrator, as she did in a Congressional hearing today, would repeat misinformation about Zohydro™ ER that has been demonstrated to be false. As informed health care experts and the U.S. Food and Drug Administration have noted for the record, Zohydro ER is no more potent than any other hydrocodone medication available. The facts are clear: Zohydro ER is the same hydrocodone currently available in a number of combination products, but without acetaminophen. In fact, in terms of hydrocodone potency, a 10 mg dose of Zohydro ER is actually the exact same potency as a 10 mg dose of Vicodin or any other hydrocodone product. There are also many marketed opioids that are more potent than hydrocodone such as oxymorphone, methadone, hydromorphone and fentanyl. In terms of maximum strength in a single pill, all other extended-release opioids have a higher dosage strength than Zohydro ER. For example, the highest dosage unit of extended-release oxycodone is 80 mg and the highest dosage unit of extended-release morphine is 200 mg, both of which are substantially higher than the highest dosage unit of Zohydro ER (which ranges from 10 mg to 50 mg). Zohydro ER is the only acetaminophen-free hydrocodone pain reliever available for long-term, daily, severe chronic pain patients who are obtaining relief with short-acting hydrocodone combination products, but who are at risk for potentially fatal liver toxicity due to their daily intake of acetaminophen. Like our nation’s leaders, we are committed to the safe and appropriate use of prescription medications. Zogenix has taken extraordinary steps to support the appropriate use of Zohydro ER through a voluntary, comprehensive set of educational tools and safeguards to augment the FDA industry mandated class-wide Risk Evaluation Mitigation Strategy (REMS) for extended-release opioids. As part of our continued efforts to provide additional safeguards against the potential diversion, overdose and misuse of Zohydro ER, Zogenix has established an External Safe Use Board of experts. Zogenix is also compensating our product representatives not on sales volume of Zohydro ER, but rather on their efforts to ensure prescribers, pharmacists and patients are educated to understand the risks and benefits of using extended-release opioids. Finally, Zogenix provides patients who are prescribed Zohydro ER access to free locking pill bottle caps and discounted safe-storage units to prevent others in the home from obtaining easy access to medicine that was not prescribed for them. On behalf of those who suffer with severe chronic pain, we will continue to move aggressively to correct false and misleading statements about Zohydro ER. The plight of people living with severe chronic pain is too important to treat otherwise. April 2, 2014 About Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII 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 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 INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL; and CYTOCHROME P450 3A4 INTERACTION 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 central nervous system disorders who need innovative treatment alternatives to help them return to normal daily functioning. Zohydro® ER is a registered mark of Zogenix, Inc. Copyright © 2014 Zogenix, Inc.. All rights reserved. Privacy | Responsibility | Terms of Use