Zogenix Submits Modified Formulation of Zohydro(R) ER With Potential Abuse Deterrent Properties for FDA Review
SAN DIEGO, Oct 01, 2014 (GLOBE NEWSWIRE via COMTEX) --
Zogenix, Inc. ZGNX, +1.74% a pharmaceutical company developing and commercializing products for the treatment of pain-related and central nervous system (CNS) disorders, today announced it has submitted to the U.S. Food and Drug Administration (FDA) a supplemental New Drug Application (sNDA) for a modified formulation of Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII, which has been designed to have abuse deterrent properties. The new capsule formulation contains additional inactive ingredients that are intended to make the product more difficult to abuse by injection and nasal insufflation. The Company anticipates a target action date on the supplement during the first quarter of 2015, and, if approved, a transition from the currently marketed product to this new formulation of Zohydro ER in the second quarter of 2015.
Zohydro ER is 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.
"The new technology being added to Zohydro ER represents a meaningful advancement because it incorporates properties designed to deter abuse yet maintain the efficacy of the medication, a central consideration throughout the product's development," said Stephen Farr, Ph.D., president of Zogenix.
Farr added: "While we are pleased to have advanced the new formulation to submission of a sNDA, this represents only one element of the comprehensive approach Zogenix has implemented to assure the appropriate use of Zohydro ER and to minimize the potential for misuse and abuse. We strongly believe that the first line of defense is educating prescribers, pharmacists and patients about the risks, benefits and appropriate use of opioids. We have implemented the FDA's Risk Evaluation and Mitigation Strategy program for extended-release/long-acting opioids and are continuing with our voluntary initiatives to support the responsible commercialization of Zohydro ER. We are pleased that the available surveillance data demonstrate that these efforts are working."
Keeping prescription medicines out of the hands of those who would abuse them is critical to any strategy aimed at stopping diversion, misuse and abuse. With this in mind, Zogenix implemented a number of industry-leading initiatives to promote the appropriate use of Zohydro ER, including providing patients access to free locking bottle caps and discounts for safe-storage units to help safeguard access to medicine in the home. Zogenix also established an independent External Safe Use Board, in place prior to the launch of Zohydro ER, to evaluate several surveillance data streams of potential abuse, misuse and diversion, which is shared with the FDA.
Approved by the FDA in October 2013, Zohydro ER provides a potential solution to patients who could benefit from an every 12-hour extended-release hydrocodone for around-the-clock management of severe chronic pain and who may be at risk for liver damage due to overexposure of acetaminophen, which can be fatal or require a liver transplant.
About Zohydro® ER
Zohydro® ER is an extended-release opioid agonist 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 as an as-needed (prn) 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 INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL; and CYTOCHROME P450 3A4 INTERACTION
See full prescribing information for complete boxed warning.
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 ingestion of Zohydro ER, especially in children, can result in a fatal overdose of hydrocodone.
Prolonged use of Zohydro ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
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.
Initiation of CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of hydrocodone from Zohydro ER.
IMPORTANT SAFETY INFORMATION
Zohydro ER is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma; known or suspected paralytic ileus; and hypersensitivity to hydrocodone bitartrate.
Zohydro ER warnings for: interactions with CNS depressants; elderly, cachectic, debilitated patients, and those with chronic pulmonary disease; hypotensive effects; patients with head injury or increased intracranial pressure; and concomitant use of CYP3A4 may increase opioid effects. Please see full prescribing information for the complete warning information.
Potential serious adverse events caused by opioids include addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; interactions with other CNS depressants; hypotensive effects; gastrointestinal conditions, and seizures. 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. ZGNX, +1.74% 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," "indicates," "will," "intends," "suggests," "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 expected timing of FDA review of the sNDA and, if approved, introduction of the new product into the marketplace; and the potential for the new technology being added to Zohydro ER to deter abuse, as well as the potential of Zogenix's other initiatives to promote safe use of Zohydro ER. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: risks and uncertainties associated with regulatory review and approval of the sNDA, including the risk that additional information or data requests from the FDA could significantly delay the FDA's review period; unexpected adverse side effects or inadequate therapeutic efficacy of the modified formulation that could limit approval and/or commercialization, or that could result in recalls or product liability claims; public concern regarding the safety of drug products such as Zohydro ER and the impact of negative publicity and political influences relating to the regulation of the pain management market in general and opioids and Zohydro ER in particular; competition from other pharmaceutical or biotechnology companies; other difficulties or delays relating to the development, testing, manufacturing and marketing of and obtaining regulatory approval for an abuse deterrent formulation of Zohydro ER; 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.
Zohydro® ER is a registered mark of Zogenix, Inc.