Application for Next Generation of Zohydro(R) ER to be Filed by October 2014
Zogenix, Inc. ZGNX +16.08% today announced an update on its development programs focused on the introduction of abuse deterrent formulations of Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII. 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 company has previously indicated that it is simultaneously developing two distinct approaches for abuse deterrent formulations of Zohydro ER. Following a recent meeting with the U.S. Food and Drug Administration (FDA), Zogenix expects to file a supplemental new drug application (sNDA) by October 2014 for a next-generation formulation of Zohydro ER Extended-Release Capsules designed to make it more difficult to abuse by injection or nasal administration.
If approved, this new formulation could be available to prescribers in early 2015. The company will continue to characterize the product's abuse deterrent properties with the goal of further amending the labeling for Zohydro ER Extended-Release Capsules in 2015 to include abuse deterrence claims consistent with the FDA's current draft Guidance for Industry, Abuse-Deterrent Opioids – Evaluation and Labeling. As of today, only one of more than thirty extended-release/long-acting opioid analgesics has abuse deterrent properties described in FDA-approved labeling for making abuse via injection more difficult and reducing abuse via the nasal route based on the draft Guidance for Industry.
Zogenix also recently selected the final tablet formulation for clinical development in its collaboration with Altus Formulation. Like the next-generation formulation, this proprietary tablet technology is designed to meet FDA's stated goal of encouraging scientific and clinical research that will advance the development of abuse deterrent technologies to address opioid medication misuse and abuse. The innovative tablet formulation of Zohydro ER incorporates multiple features to maintain the extended-release property of the medication when crushed or chewed, reducing one of the ways in which opioids are abused through oral ingestion, as well other features to address abuse by injection or nasal administration.
The company is targeting a new drug application (NDA) submission for this tablet formulation during the first half of 2016, which will reference the approved NDA for Zohydro ER with respect to previous findings of safety and efficacy. The tablet formulation is designed to have the same hydrocodone release profile as the currently approved capsule formulation of Zohydro ER when used as intended, greatly simplifying its development program.
"We believe we have two strong technology options to deter misuse and abuse without affecting the established safety and efficacy profile of Zohydro ER, and look forward to submitting our data to the FDA with the goal of bringing these new options to patients," said Stephen Farr, Ph.D., President of Zogenix. "This dual approach will allow us to potentially launch our next generation of Zohydro ER Extended-Release Capsules in early 2015, followed by the tablet formulation with advanced proprietary abuse deterrent technology in 2016. We also continue to take part in comprehensive and collaborative efforts with prescribers, pharmacists and government officials to help ensure appropriate patients have access to the medications that will best support the management of their severe chronic pain."
In addition to working with FDA to integrate abuse deterrent properties into Zohydro ER, Zogenix strongly supports more comprehensive approaches to addressing the public health challenge of prescription drug abuse. Zogenix has taken extraordinary steps to support the appropriate use of Zohydro ER through a voluntary set of educational tools and safeguards to augment the FDA industry mandated class-wide Risk Evaluation Mitigation Strategy (REMS) for extended-release opioids. The company has implemented novel initiatives, such as providing Zohydro ER patients free locking pill bottle caps and discounts for safe-storage units to help prevent other people from gaining access to their medications. Prior to the availability of Zohydro ER, Zogenix established an independent External Safe Use Board to assess and make recommendations on surveillance programs and data collection related to misuse and diversion of the product.
Approved by the FDA in October 2013, Zohydro ER provides a potential solution to patients who could benefit from an 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 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. ZGNX +16.08% 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.
For more information about Zogenix, please visit: www.Zogenix.com .
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 potential to develop abuse deterrent formulations of Zohydro ER, the timing of regulatory submissions and potential FDA approvals. 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: risks and uncertainties associated with the development and regulatory approval of an abuse deterrent formulation and Zogenix's reliance on Altus and its drug delivery platform in such development efforts; unexpected adverse side effects or inadequate therapeutic efficacy of the abuse deterrent formulations 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.