SAN DIEGO, April 24, 2014 /PRNewswire/ -- We at Zogenix have reviewed the letter to Vermont Governor Peter Shumlin signed by the Center for Lawful Access and Abuse Deterrence (CLAAD), The American Academy of Pain Management and the National Fibromyalgia & Chronic Pain Association, which asks the Governor and health commissioner to participate in a "multi-lateral meeting to develop a more thorough approach" to stemming Vermont's prescription drug abuse epidemic. We agree with and commit our support to the fair and consistent approach proposed today. Several states have already adopted more stringent prescriber guidelines and we help educate prescribers on these guidelines as the central focus of our efforts. We would welcome the opportunity to help Vermont implement tighter prescriber guidelines or requirements.
As we have previously stated, Zogenix would welcome the opportunity to be a part of a collaborative effort to find solutions to this issue while balancing the needs of chronic pain patients. As leaders in this field at the Centers for Disease Control, the Office of National Drug Control Policy and the U.S. Food and Drug Administration have made clear, finding solutions to this complex problem will require a fully integrated common sense approach supported by all stakeholders in a unified effort across the entire class of opioids medications. Singling out any one product or one company within the same class only distracts from the much needed effort to solve a complex problem. What is being proposed based on inaccurate information can become an opportunity to really make a positive difference for appropriate prescribing of all opioids which Zogenix strongly supports.
We are ready to work with the states to help address the serious problem of opioid abuse in a thoughtful manner.
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.