Vermont Business Magazine The following is a statement from the manufacturer of Zohydro ER, a recently approved opioid pain management medication. Governor Shumlin, in an effort to limit the abuse of prescription opioids because of their relationship to an ongoing opioid abuse problem in Vermont, through prescription medication and heroin, has called on the FDA to reverse its approval of Zohydro. The advocacy groups referenced below suggest that a broader approach needs to be taken than banning just one medication.
Vermont is not alone in its concern. Massachusetts banned the drug, but that ban was shot down in court, so on Tuesday,Governor Deval Patrick’s administration imposed what theBoston Globecalled "sweeping restrictions" on prescribing the drug.
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Zogenix Statement
We at Zogenix have reviewed theletter to Vermont Governor Peter Shumlinsigned 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 stemmingVermont'sprescription 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 helpVermontimplement 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
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.
Pleaseclick hereto see the Zohydro ER professional product labeling for the completeboxed warningand safety information.
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WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME and INTERACTION WITH ALCOHOL
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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.
SAN DIEGO,April 24, 2014/PRNewswire/ --Zogenix, Inc.