Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing
and commercializing products for the treatment of central nervous
system (CNS) disorders, today announced that the U.S. Food and Drug
Administration (FDA) has approved a new formulation of Zohydro® ER
(hydrocodone bitartrate) Extended-Release Capsules, CII, with
BeadTek™. BeadTek is a formulation technology designed to provide
abuse-deterrent properties without changing the release properties
of hydrocodone when Zohydro ER is used as intended. Concurrently,
Zogenix has ongoing Human Abuse Liability studies, which will
further characterize the abuse-deterrent properties of the new
formulation. Zogenix intends to submit these data in the second
half of 2015 to the FDA to support an amended product label,
including abuse-deterrent claims consistent with the FDA's current
draft Guidance for Industry, Abuse-Deterrent Opioids – Evaluation
and Labeling.
BeadTek incorporates well-known pharmaceutical excipients that
immediately form a viscous gel when crushed and dissolved in
liquids or solvents. Zohydro ER is the only long-acting hydrocodone
product administered every 12 hours, and the new formulation
maintains the same efficacy and pharmacokinetic profile of the
original formulation. Transition to Zohydro ER with BeadTek is
expected to occur in the second quarter of 2015 for all prescribed
strengths ranging from 10 mg to 50 mg, without disruption to
patients currently on therapy.
"While we are very pleased with the outcomes from our safe use
initiatives, implemented with the introduction of Zohydro ER last
year, we believe moving forward with this formulation change at the
earliest possible time is a responsible action for us to take,"
said Stephen Farr, Ph.D., president of Zogenix. "We are also
committed to completing the ongoing studies to seek additional
changes in the product label relating to abuse-deterrent properties
by the end of the year."
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. Zohydro ER
does not contain acetaminophen, unlike many immediate-release
hydrocodone products, reducing the risk for potential liver
toxicity due to overexposure of acetaminophen.
About BeadTek™
BeadTek was developed using safe, well-known excipients and
proprietary manufacturing processes to create an inactive
ingredient that immediately forms a viscous gel when crushed and
dissolved in liquids or solvents. All of the beads within the
medication capsule are indistinguishable in color, shape, density
and size, and do not impact the drug release profile when taken as
directed.
INDICATION
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 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 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 has 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. With intravenous abuse, the inactive ingredients in Zohydro
ER can result in death, local tissue necrosis, infection, pulmonary
granulomas, and increased risk of endocarditis and valvular heart
injury. Parenteral drug abuse is commonly associated with
transmission of infectious diseases such as hepatitis and HIV.
About Zogenix
Zogenix, Inc. (Nasdaq:ZGNX) is a pharmaceutical company
committed to developing and commercializing therapies that address
specific clinical needs for people living with CNS disorders who
need innovative treatment alternatives to help them return to
normal daily functioning. For more information, go to
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 ability of BeadTek to reduce the abuse potential of
Zohydro ER; the expected timing of the transition to the Zohydro ER
formulation with BeadTek and the submission of data to support an
amended label for Zohydro ER with BeadTek and the transition to the
Zohydro ER with BeadTek formulation; and the safety and
effectiveness of Zohydro ER with BeadTek. Actual results may differ
from those set forth in this press release due to the risks and
uncertainties inherent in Zogenix's business, including, without
limitation: Zogenix's dependence on the successful
commercialization of Zohydro ER; 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; unexpected adverse side effects or
inadequate therapeutic efficacy of the modified Zohydro ER
formulation that could limit commercialization, or that could
result in recalls or product liability claims; Zogenix's ability to
achieve broad market acceptance and generate revenues from sales of
Zohydro ER; competition from other pharmaceutical or biotechnology
companies; Zogenix's dependence on its contract manufacturers and
its ability to ensure an adequate and continued supply of Zohydro
ER with BeadTek to meet market demand for the transition to the
modified Zohydro ER formulation; other difficulties or delays
relating to the development, testing, manufacturing and marketing
of 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.
BeadTek™ is a trademark used by Zogenix under license.
CONTACT: Investors
Zack Kubow |The Ruth Group
646.536.7020 | zkubow@theruthgroup.com
Media
David Polk | Chandler Chicco Companies
310.309.1029 | DPolk@chandlerchiccocompanies.com
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