Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing
and commercializing products for the treatment of central nervous
system disorders and pain, today announced that the U.S. Food and
Drug Administration (FDA) has approved ZohydroTM ER (hydrocodone
bitartrate) extended-release capsules, an opioid agonist,
extended-release oral formulation of 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. Zogenix expects to
launch Zohydro ER in approximately four months.
Zohydro ER is the first extended-release formulation hydrocodone
therapy without acetaminophen. The use of products containing
acetaminophen in high doses over long periods of time has the
potential for causing liver injury. Acetaminophen overdose is a
leading cause of acute liver failure in the United States, with 63
percent of unintentional acetaminophen overdoses attributed to the
use of hydrocodone-acetaminophen combination products.1
"Zohydro ER fulfills a critical need among people living with
chronic pain who meet the criteria for therapy with extended
release opioids. It is the first extended-release hydrocodone
medicine that is acetaminophen-free. Also, a significant proportion
of patients on existing forms of immediate-release
hydrocodone-acetaminophen combination treatments have liver disease
or risk factors, and the availability of an acetaminophen-free
formulation encompassing a range of hydrocodone doses is an
important therapeutic option for these patients," said Dr. Srinivas
Nalamachu, M.D., a pain specialist at the International Clinical
Research Institute, Overland Park, Kansas and investigator in the
clinical trials of Zohydro ER.
Zogenix is committed to supporting appropriate use of opioid
pain treatments for patients suffering from chronic pain. Zogenix
will implement the Risk Evaluation and Mitigation Strategy (REMS)
for Extended Release (ER) and Long Acting (LA) Opioids required by
the FDA for all the products in the class. In addition,
Zogenix will participate in the design and implementation of
post-marketing studies, as recently outlined by the FDA. NDA
sponsors of ER/LA opioids are now required to conduct studies to
assess the serious risks associated with long-term use.
"In addition to the REMS, Zogenix has voluntarily developed a
series of safe use initiatives to support the appropriate use of
Zohydro ER," said Stephen Farr, Ph.D., president of Zogenix. "As
part of these initiatives, we will provide state-of-the-art
integrated educational resources for patients, physicians and
pharmacists and leverage surveillance programs to monitor for
misuse and abuse. Further, Zogenix has also started the
development of an abuse deterrent formulation of Zohydro ER and we
are committed to advancing the program as rapidly as possible."
Zohydro ER capsules will be available in six dosage strengths
ranging from 10 mg to 50 mg with dosing every 12 hours. Zohydro ER
is classified as a Drug Enforcement Agency (DEA) Schedule II drug,
making it subject to stricter prescribing and dispensing rules
compared to the immediate-release hydrocodone-acetaminophen
combination products, which are currently classified as Schedule
III drugs. On October 24, 2013, the FDA announced its intention to
submit a formal recommendation to Health and Human Services by
early December to reclassify hydrocodone combination products from
DEA Schedule III to Schedule II, however, the date of
implementation is currently unknown.
Zohydro ER was studied in over 1,100 people living with chronic
pain who participated in the pivotal Phase 3 efficacy study or an
open-label Phase 3 long-term safety study. The efficacy study that
enrolled over 500 subjects with chronic low back pain met the
primary endpoint in demonstrating that treatment with Zohydro ER
resulted in significantly improved chronic pain relief compared to
placebo. The key secondary endpoint was also achieved: a
significantly higher number of subjects experienced at least 30%
improvement in pain intensity from screening to end of study
(67.5%, Zohydro ER versus 31.1%, placebo). The safety profile
of Zohydro ER in both Phase 3 studies was consistent with other
opioids in that the most frequent treatment emergent adverse events
were constipation, nausea, drowsiness (somnolence), fatigue,
headache, dizziness, dry mouth, vomiting and itching
(pruritus).
Zohydro ER uses Alkermes Pharma Ireland Limited'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.
Conference Call and Web Cast
Zogenix will hold a conference call on Monday, October 28, 2013
at 8:30 a.m. ET to discuss the FDA approval of Zohydro ER.
To participate, please dial (866) 202-0886 (U.S.) or (617)
213-8841 (International); participant passcode: 35082590. To access
the live webcast please visit the Zogenix Investor Relations
website at http://ir.zogenix.com.
A replay of the conference call will be available beginning
October 28, 2013 at 9:00 p.m. ET until November 4, 2013, by dialing
(888) 286-8010 (U.S.) or (617) 801-6888 (International); passcode:
29176780. A replay of the webcast will also be accessible on the
Investor Relations website for one month, through November 28,
2013.
Discussion during the conference call may include
forward-looking statements regarding such topics as, but not
limited to, the Company's commercial activities relating to Zohydro
ER and SUMAVEL DosePro, the Company's financial status and any
comments the Company may make about its future plans or prospects
in response to questions from participants on the conference
call.
About the voluntary safe use initiatives for Zohydro
ER
To support the appropriate use of Zohydro ER, Zogenix is
committed to responsible management of product distribution and
commercialization with the following voluntary safe use
initiatives:
- Integrated broad-ranging educational resources
for patients, physicians and pharmacists, that complement and build
upon the ER/LA opioid analgesics REMS, including assessment tools
and case-based simulated training
- Ongoing surveillance and monitoring of key
measures from the date of launch which are intended to detect
potential misuse, abuse and diversion of Zohydro ER
- Commercial activity focused on selected
physicians who are experienced in the prescribing of Schedule II
extended-release opioids, as well as proactive medical outreach to
those who have expressed an interest in prescribing Zohydro ER
- Certification of Zogenix territory
representatives of completion of education and training on
all REMS and voluntary safe use initiatives for Zohydro ER
- Incentive compensation based exclusively on achieving
safe use goals rather than prescription sales volume for
Zogenix territory representatives throughout the launch year
- Distribution of safe storage mechanisms to
encourage patients to practice at-home safekeeping of their
prescribed quantity of Zohydro ER
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 (prn)
analgesic.
Please see the Zohydro ER full prescribing
information 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.
About Zogenix
Zogenix, Inc. (Nasdaq:ZGNX), with offices in San Diego and
Emeryville, California, is a pharmaceutical company committed to
developing and commercializing therapies that address specific
clinical needs for people living with CNS and pain-related
conditions who need innovative treatment alternatives to help them
return to normal daily functioning. Zogenix developed and
commercialized the first needle-free subcutaneous injection,
SUMAVEL® DosePro® (sumatriptan injection) for migraine and cluster
headache. Zogenix recently received FDA approval for Zohydro ER
(hydrocodone bitartrate) extended-release capsules, the first
extended-release oral formulation of hydrocodone without
acetaminophen. The development pipeline for Zogenix includes a
once-monthly subcutaneous injection for schizophrenia.
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 timing of the launch of Zohydro ER, the size of the
chronic pain market and the potential of Zohydro ER to provide a
significant new management alternative and be well positioned in
that market, and the FDA's proposal to change the schedule for
hydrocodone combination products from Schedule III to Schedule II
under the Controlled Substances Act. 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: the timing and success of
any subsequent commercial launch of Zohydro ER; Zogenix's ability
to successfully launch and drive market demand for Zohydro ER;
Zogenix's ability to obtain additional financing as needed to
support its operations; the scope and validity of patent protection
for Zohydro ER and Zogenix's ability to commercialize Zohydro ER
without infringing the patent rights of others; unexpected adverse
side effects or inadequate therapeutic efficacy of Zohydro ER that
could limit commercialization, or that could result in recalls or
product liability claims; 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 Zogenix's products; 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.
ZohydroTM ER is a trademark and SUMAVEL® and DosePro® are
registered trademarks of Zogenix, Inc.
SODAS® is a trademark of Alkermes Pharma Ireland Limited
1 Michna, E, Duh, MS, Korves, C, Dahl, JL. Removal of
opioid/acetaminophen combination prescription pain medications:
assessing the evidence for hepatotoxicity and consequences of
removal of these medications. Pain Medicine. 2010; 11: 369-378.
CONTACT: Investors
Zack Kubow | The Ruth Group
646.536.7020 | zkubow@theruthgroup.com
Media
Julie Normart | WCG
415.946.1087 | jnormart@wcgworld.com
Zogenix (NASDAQ:ZGNX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Zogenix (NASDAQ:ZGNX)
Historical Stock Chart
From Apr 2023 to Apr 2024