SAN DIEGO, May 2, 2012 /PRNewswire/ -- Zogenix, Inc.
(NASDAQ: ZGNX), a pharmaceutical company commercializing and
developing products for the treatment of central nervous system
disorders and pain, announced today that the Company has submitted
a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for Zohydro™ (hydrocodone bitartrate
extended-release capsules), Zogenix's lead investigational product
candidate for the treatment of chronic pain.
Zohydro is a novel, oral, single-entity (without acetaminophen)
extended-release formulation of various strengths of hydrocodone
intended for administration every 12 hours for around the
clock management of moderate to severe chronic pain. If approved,
Zohydro could be the first hydrocodone product to offer the benefit
of less frequent dosing and the ability to treat patients with
chronic pain without the risk of acetaminophen-related liver
injury. Currently, hydrocodone is only available in
immediate-release, combination products, most commonly with the
analgesic acetaminophen, and requires dosing every 4 to 6 hours.
Zohydro, classified as a Drug Enforcement Agency (DEA) Schedule II
drug product, would carry more strict prescription and dispensing
rules as compared to the currently available hydrocodone
combination products. In addition, Zogenix has included in the NDA
a comprehensive Risk Evaluation and Mitigation Strategy (REMS) that
is consistent with current FDA and industry-wide guidelines for
extended-release opioid products. The REMS is intended
to control inappropriate prescribing, misuse and abuse of
extended-release opioids while maintaining patient access to
essential pain medications.
"The NDA submission for Zohydro is a significant milestone,
bringing us another step closer to making this important
acetaminophen-free hydrocodone treatment option available to
patients in need of around the clock therapy for chronic pain,"
said Stephen Farr, Ph.D., president
and chief operating officer of Zogenix. "Hydrocodone is often a
physician's first opioid recommendation for treating acute,
moderate or moderately severe pain. However, many patients are
being treated with hydrocodone combination products that include
acetaminophen and, when used in high dosages or over long periods
of time, put themselves at risk for developing liver injury.
Zohydro could provide a significant new treatment alternative that
does not contribute to this health risk."
The NDA submission is based on data from over 1,100 patients
with chronic pain participating in the pivotal Phase 3 efficacy
study (Study 801), and an open-label Phase 3
safety study (Study 802) of Zohydro. Study 801 successfully
met its primary efficacy endpoint, demonstrating that Zohydro
resulted in significantly (p=0.008) improved chronic pain relief
compared to placebo. The two key secondary endpoints in this study
- the proportion of patients with at least 30% improvement in pain
intensity and the improvement of overall satisfaction of medication
- were also met. Additional study endpoints were supportive
of the efficacy of Zohydro compared to placebo. The study
demonstrated that Zohydro was generally safe and well tolerated.
Overall, the most commonly reported adverse events (greater than or
equal to 2%) in the placebo-controlled pivotal Phase 3 efficacy
Study 801 in opioid-experienced patients were consistent with those
typically seen with chronic opioid therapy and were
constipation, nausea, somnolence, fatigue, headache, dizziness, dry
mouth, vomiting and pruritus. Study 802, in which patients received
Zohydro for up to 12 months, further demonstrated that Zohydro was
generally safe and well tolerated, and the incidence of adverse
events was consistent with that seen in the pivotal Phase 3
efficacy study.
In conjunction with Zohydro's NDA submission, Zogenix is
required to make a milestone payment of $1.0
million to Alkermes Pharma Ireland Limited (APIL), a
subsidiary of Alkermes, plc, under the Company's exclusive license
agreement with APIL in the U.S. for Zohydro.
About Zohydro
Zohydro is a novel, oral, single-entity extended-release
formulation of hydrocodone without acetaminophen for the management
of moderate to severe chronic pain in patients requiring around the
clock opioid therapy. If approved, Zohydro could be the first
single-entity hydrocodone therapy, avoiding the potential for liver
injury associated with the use of acetaminophen in high doses or
over long periods of time.
Zohydro uses APIL's patented Spheroidal Oral Drug Absorption
System (SODAS®) drug delivery technology which serves to
enhance the release profile of hydrocodone to provide
extended-release pain relief relative to existing immediate-release
combination products.
About Chronic Pain
Chronic pain is defined as ongoing or recurrent pain that
adversely affects an individual's well-being. An estimated
116 million people in the United
States are burdened with chronic pain, at an estimated
national economic cost of $560 to $635
billion annually.
Chronic pain can be treated with both immediate-release and
extended-release opioids. Currently marketed hydrocodone products
are only immediate-release and contain an analgesic combination
ingredient, primarily acetaminophen. Acetaminophen may cause liver
injury when used in high dosages, over long periods of time or in
accidental overdoses due to multiple acetaminophen products being
taken at once.
About Zogenix
Zogenix, Inc. (NASDAQ: ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical
company commercializing and developing products for the treatment
of central nervous system disorders and pain. Zogenix's first
commercial product, SUMAVEL® DosePro®
(sumatriptan injection) Needle-free Delivery System, was launched
in January 2010 for the acute
treatment of migraine and cluster headache. Zogenix's lead
investigational product candidate, Zohydro™ (hydrocodone
bitartrate), is a novel, oral, single-entity (without
acetaminophen) extended-release formulation of various strengths of
hydrocodone intended for administration every 12 hours for
around the clock management of moderate to severe chronic pain.
Zogenix submitted an NDA to the FDA for Zohydro in May 2012. Zogenix's second DosePro
investigational product candidate, Relday™, is a proprietary,
long-acting injectable formulation of risperidone for the treatment
of schizophrenia.
For additional information, please visit www.zogenix.com.
Forward Looking Statements
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 for Zohydro to be the first approved oral,
single-entity extended-release formulation of hydrocodone; and the
size of the chronic pain market and the potential of Zohydro to
provide a significant new treatment alternative and be well
positioned in that market. 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 release due to the risk and
uncertainties inherent in Zogenix's business, including, without
limitation: the top-line data Zogenix has reported for Zohydro is
based on preliminary analysis of key efficacy and safety data, and
such data may change following a more comprehensive review of the
data related to the clinical trial, and may also change in
connection with the continued review of such data as part of
Zogenix's submission and the FDA's review of the NDA for Zohydro;
the potential for delays associated with any additional data
required to be submitted by Zogenix in support of the NDA; the
potential for Zohydro to receive regulatory approval on a timely
basis or at all; the potential for adverse safety findings relating
to Zohydro to delay or prevent regulatory approval or
commercialization; the impact of any inability to raise sufficient
capital to fund ongoing operations; the ability of Zogenix and its
licensors to obtain, maintain and successfully enforce adequate
patent and other intellectual property protection of its products
and product candidates and the ability to operate its business
without infringing the intellectual property rights of others; and
other risks described in Zogenix's 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 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.
SODAS® is a trademark of Alkermes Pharma Ireland
Limited.
SUMAVEL ®, DosePro ®, Relday™ and Zohydro™
are trademarks of Zogenix, Inc.
INVESTORS:
|
MEDIA:
|
Zack
Kubow | The Ruth Group
|
Emily Poe
| WCG
|
646.536.7020 | zkubow@theruthgroup.com
|
212.301.7183 | epoe@wcgworld.com
|
SOURCE Zogenix, Inc.