Zogenix, Inc. Home Careers Where MEDICINE Meets TECHNOLOGY About Zogenix Responsibility Products Pipeline Technology Newsroom Investors Contact VIEWPOINTS Latest Entries: 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 May 27, 2014 The Appropriate Patient for Zohydro™ ER At Zogenix, we firmly believe it is critically important that Zohydro™ ER (hydrocodone bitartrate) extended-release capsules, CII and all extended-release/long-acting (ER/LA) opioids are only prescribed by an educated health care provider, experienced in prescribing ER opioids for management of severe chronic pain for the appropriate patient. Zohydro ER is approved by the U.S. Food and Drug Administration (FDA) as a safe and effective treatment when taken as prescribed for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.1 In fact, Zohydro ER was developed specifically for the estimated 2.4 million Americans with severe chronic pain who are currently taking daily, around-the-clock, immediate-release hydrocodone with acetaminophen, the most commonly prescribed hydrocodone product. These patients may be at risk for liver damage due to overexposure of acetaminophen, which can be fatal or require a liver transplant.2 There are also patients who are not appropriate candidates for Zohydro ER. As we have been stating and promoting since even before our product availability, Zohydro ER is not indicated for and should never be prescribed for patients with acute pain, such as those undergoing dental procedures. Dentists should not be prescribing Zohydro ER or any other ER opioid. Our product representatives and medical affairs specialists are working hard to educate prescribers who may have patients who are appropriate candidates for Zohydro ER. Furthermore, if we discover that health care providers are prescribing Zohydro ER for acute pain or non-severe chronic pain, we will proactively reach out and educate these providers as to the appropriate use of our medication. It is important to understand that our focus has and always will be on the specific group of prescribers who has experience in prescribing extended-release opioids, as these prescribers treat the right patient for Zohydro ER – those patients suffering from pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Zohydro™ ER Prescribing Information. ZohydroER.com. FDA analysis of IMS Health Total Patient Tracker data for 2011 (presented at Zohydro ER Advisory Committee, December 2012). About Zohydro ER INDICATION 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. For more information about Zohydro ER, please visit: www.ZohydroEr.com or the Zohydro ER REMS website at www.ZohydroERREMS.com. 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. Copyright © 2014 Zogenix, Inc.. All rights reserved. Privacy | Responsibility | Terms of Use