, 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
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.
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.
SOURCE Zogenix, Inc.