Click here to close now.




















Welcome!

News Feed Item

Zogenix Responds to Governor's Action Singling Out Zohydro™ ER in Massachusetts, Encourages Officials to Consider Patient Needs and Effective Class-Wide Measures

SAN DIEGO, April 23, 2014 /PRNewswire/ -- Zogenix will continue to work to ensure patients suffering from severe chronic pain have access to the FDA-approved medications they need in every state nationwide, including Massachusetts. We are once again disappointed that Governor Patrick would issue another immediate restriction without first accepting our offer to discuss the facts and work together to address the needs of patients while combating abuse and addiction.

We fully support appropriate guidelines on the safe use, serious risks, proper storage and responsible disposal of extended-release and long-acting opioid analgesics. Zogenix is following a rigorous program required by the U.S. Food and Drug Administration (FDA) to ensure that Zohydro™ ER (hydrocodone bitartrate) extended-release capsules, CII is used safely and responsibly. Zogenix strongly disagrees with the Governor's decision once again to single out Zohydro ER, when the facts show that the risks of abuse with Zohydro ER are no different than those of most other long-acting opioid products on the market today. For that reason, FDA has required that Zohydro ER adhere to the same strict labeling requirements and same requirement for post-market studies, training programs for prescribers, and Medication Guides for patients as all other long-acting opioid analgesics. Zogenix urges the Governor to respect the carefully designed approach imposed by the FDA, and to address the problem of opioid abuse on a class-wide basis. 

The active ingredient in Zohydro ER, hydrocodone bitartrate, is no more potent than most other opioids. The amount of drug in each Zohydro ER capsule is consistent with, and on a relative basis, lower than that of comparable extended-release opioid products. And, the singular focus on Zohydro ER for not having an abuse-deterrent formulation is misplaced. In fact, there are more than 30 extended-release opioids on the market and only one has an FDA-approved label indicating it has abuse deterrent properties. Most important, no product on the market today addresses the most prevalent form of abuse, taking an excessive number of tablets or capsules. 

Finally, it is important to remember that Zohydro ER was approved by the FDA after an exhaustive 18-month review of the clinical data. This rigorous FDA review process serves the nation's public health needs, the medical community and those in severe chronic pain.

Zogenix stands ready to work with the State of Massachusetts to help address the serious problem of opioid abuse and to focus, with the Governor and his team, on the root causes of the problem and the solutions most likely to make a difference. Imposing restrictions on one specific treatment, without developing a full understanding of the facts and the causes of the problem, does not serve the public interest.

To read a fair and balanced view of the facts from experts, we refer you to the FDA Commissioner's speech given April 22, 2014 at the Prescription Drug Abuse Summit in Atlanta, Georgia and the American Academy of Pain Management statement on Zohydro ER.

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 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 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.

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.

Zohydro™ ER is a trademark of Zogenix, Inc.

CONTACT:

Investors


Zack Kubow | The Ruth Group


646.536.7020  | [email protected]




Media


Victoria Fort | Chandler Chicco Companies


202.361.0445 | [email protected]

SOURCE Zogenix, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that VividCortex, the monitoring solution for the modern data system, will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. The database is the heart of most applications, but it’s also the part that’s hardest to scale, monitor, and optimize even as it’s growing 50% year over year. VividCortex is the first unified suite of database monitoring tools specifically desi...
In their session at 17th Cloud Expo, Hal Schwartz, CEO of Secure Infrastructure & Services (SIAS), and Chuck Paolillo, CTO of Secure Infrastructure & Services (SIAS), provide a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions. In his role as CEO of Secure Infrastructure & Services (SIAS), Hal Schwartz provides leadership and direction for the company.
Container technology is sending shock waves through the world of cloud computing. Heralded as the 'next big thing,' containers provide software owners a consistent way to package their software and dependencies while infrastructure operators benefit from a standard way to deploy and run them. Containers present new challenges for tracking usage due to their dynamic nature. They can also be deployed to bare metal, virtual machines and various cloud platforms. How do software owners track the usag...
As organizations shift towards IT-as-a-service models, the need for managing and protecting data residing across physical, virtual, and now cloud environments grows with it. CommVault can ensure protection and E-Discovery of your data – whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise. In his session at 17th Cloud Expo, Randy De Meno, Chief Technologist - Windows Products and Microsoft Partnerships at Com...
In a recent research, analyst firm IDC found that the average cost of a critical application failure is $500,000 to $1 million per hour and the average total cost of unplanned application downtime is $1.25 billion to $2.5 billion per year for Fortune 1000 companies. In addition to the findings on the cost of the downtime, the research also highlighted best practices for development, testing, application support, infrastructure, and operations teams.
Mobile, social, Big Data, and cloud have fundamentally changed the way we live. “Anytime, anywhere” access to data and information is no longer a luxury; it’s a requirement, in both our personal and professional lives. For IT organizations, this means pressure has never been greater to deliver meaningful services to the business and customers.
SYS-CON Events announced today that MobiDev, a software development company, will exhibit at the 17th International Cloud Expo®, which will take place November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software development company with representative offices in Atlanta (US), Sheffield (UK) and Würzburg (Germany); and development centers in Ukraine. Since 2009 it has grown from a small group of passionate engineers and business managers to a full-scale mobi...
There are many considerations when moving applications from on-premise to cloud. It is critical to understand the benefits and also challenges of this migration. A successful migration will result in lower Total Cost of Ownership, yet offer the same or higher level of robustness. In his session at 15th Cloud Expo, Michael Meiner, an Engineering Director at Oracle, Corporation, analyzed a range of cloud offerings (IaaS, PaaS, SaaS) and discussed the benefits/challenges of migrating to each offe...
"We've just seen a huge influx of new partners coming into our ecosystem, and partners building unique offerings on top of our API set," explained Seth Bostock, Chief Executive Officer at IndependenceIT, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
Digital Transformation is the ultimate goal of cloud computing and related initiatives. The phrase is certainly not a precise one, and as subject to hand-waving and distortion as any high-falutin' terminology in the world of information technology. Yet it is an excellent choice of words to describe what enterprise IT—and by extension, organizations in general—should be working to achieve. Digital Transformation means: handling all the data types being found and created in the organizat...
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
Chuck Piluso presented a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions. Prior to Secure Infrastructure and Services, Mr. Piluso founded North American Telecommunication Corporation, a facilities-based Competitive Local Exchange Carrier licensed by the Public Service Commission in 10 states, serving as the company's chairman and president from 1997 to 2000. Between 1990 and 1997, Mr. Piluso served as chairman & founder of International Te...
The Software Defined Data Center (SDDC), which enables organizations to seamlessly run in a hybrid cloud model (public + private cloud), is here to stay. IDC estimates that the software-defined networking market will be valued at $3.7 billion by 2016. Security is a key component and benefit of the SDDC, and offers an opportunity to build security 'from the ground up' and weave it into the environment from day one. In his session at 16th Cloud Expo, Reuven Harrison, CTO and Co-Founder of Tufin,...
With SaaS use rampant across organizations, how can IT departments track company data and maintain security? More and more departments are commissioning their own solutions and bypassing IT. A cloud environment is amorphous and powerful, allowing you to set up solutions for all of your user needs: document sharing and collaboration, mobile access, e-mail, even industry-specific applications. In his session at 16th Cloud Expo, Shawn Mills, President and a founder of Green House Data, discussed h...
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducte...