Zogenix Takes Legal Action in Federal Court to Block Massachusetts Improper Ban on Zohydro ER
SAN DIEGO, April 7, 2014 /PRNewswire/ -- Zogenix, Inc. (Nasdaq: ZGNX), a pharmaceutical company developing and commercializing products for the treatment of pain-related and central nervous system (CNS) disorders, today filed a lawsuit in the U.S. District Court in Massachusetts requesting the court to grant a temporary restraining order against execution of the executive order recently announced by Governor Deval Patrick, which prohibits the prescribing and dispensing of the Company's prescription pain product that was approved by the U.S. Food and Drug Administration (FDA). Zohydro ER (hydrocodone bitartrate) extended-release capsules, is the first and only extended-release hydrocodone without acetaminophen 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.
The suit argues that this decision is in direct conflict with the authority of the FDA to determine on behalf of the public whether a drug is safe and effective, and to impose the measures necessary to ensure that the drug will be used safely and appropriately.
The legal action comes after a formal written request to the Governor for a meeting to discuss the facts about the product went unanswered. For those patients in Massachusetts struggling every day with severe chronic pain who are tolerating immediate-release hydrocodone therapies which contain acetaminophen, having a new option of hydrocodone could provide a significant benefit at the same daily dose currently being prescribed and taken 4 – 6 times per day and reduce their risk to overdose of acetaminophen.
"Governor Patrick's unilateral action was taken without any communication or advanced notice. In very limited interactions with his staff after the decision, we are convinced the decision was driven by factual inaccuracies about the science and the data. Unfortunately, it left us little recourse but to put the needs of patients in severe chronic pain ahead of politics and file for an injunction to stop the executive order," said Roger Hawley, chief executive officer of Zogenix. "Zohydro ER was approved by the FDA after an exhaustive 18-month review of the clinical trial data. This rigorous FDA review process serves the nation's public health needs, the medical community and those in severe chronic pain, and the FDA regulatory authority simply should not be usurped by individual states."
Zogenix Commitment to Ensuring Appropriate Use
Zogenix has taken extraordinary steps to ensure its medicine is used safely and prescribed according to the recently revised label required by the FDA for all extended release/long acting (ER/LA) opioid analgesics. In addition, Zogenix is also participating with the NDA sponsors of other ER/LA opioids in the design and conduct of post-marketing required studies to assess the potential for serious risks associated with long-term use of these medications.
Zohydro ER is the only hydrocodone product on the market today that is subject to a Risk Evaluation and Mitigation Strategy (REMS) specifically developed by the FDA to minimize the risk of abuse of long acting opioid drugs, and is the only hydrocodone product currently subject to Schedule II controls by the Drug Enforcement Administration. These requirements make Zohydro ER the most comprehensively regulated hydrocodone product on the market today, with more safeguards against misuse, abuse and diversion than any other hydrocodone-based product.
Extensive education is provided to patients and prescribers on the proper use of Zohydro ER by Zogenix to ensure they fully understand the risks associated with the use of extended release opioids. Zogenix has also implemented a broad and vigorous surveillance system under the oversight of an external safe use board to detect for signals of abuse, misuse and diversion in order to take immediate corrective actions, which began prior to the product becoming available on the market.
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.
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding: the legality and appropriateness of the ban of Zohydro ER by executive order of the Governor of Massachusetts. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: Zogenix may be unsuccessful in the lawsuit seeking a temporary restraining order and may incur significant costs in connection with such lawsuit; and other risks detailed in Zogenix's prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
SOURCE Zogenix, Inc.
Posted: April 2014