Pfizer Inc. (NYSE: PFE) announced today that a Phase 3 study to
assess the use of LYRICA® (pregabalin) as adjunctive therapy for
epilepsy patients 5 to 65 years of age with primary generalized
tonic-clonic (PGTC) seizures did not meet its primary endpoint.
Treatment with LYRICA did not result in a statistically significant
reduction in seizure frequency versus placebo. Lyrica is not
indicated in any population for the treatment of PGTC seizures. The
study was a post-marketing commitment to the U.S. Food and Drug
Administration (FDA).
“Pfizer is committed to the study of patient populations with
unmet treatment needs, including pediatric and adult patients
experiencing generalized tonic-clonic seizures,” said Juan Ovalle,
M.D., Global Chief Medical Officer, R&D and Medical, Upjohn, a
division of Pfizer. “These data contribute to our growing
understanding of pediatric epilepsy and reflect our responsibility
to advance scientific knowledge through post-marketing
research.”
The LYRICA Pediatric Epilepsy Program is composed of six studies
in patients with epilepsy evaluating LYRICA as adjunctive therapy,
five of which have been completed. For more information, visit
www.clinicaltrials.gov.
About the Study
This Phase 3 study was a 12-week randomized, double-blind,
placebo-controlled, multi-center study evaluating the efficacy of
two doses of LYRICA in patients 5 to 65 years of age with PGTC
seizures. The study was conducted at 70 sites in 21 countries with
219 patients. Patients were randomized in a 1:1:1 ratio to receive
placebo, or one of two fixed doses of LYRICA twice daily: LYRICA 5
mg/kg/day (7 mg/kg/day for subjects with body weight <30 kg, and
300 mg/day for those 17 years of age and older) or LYRICA 10
mg/kg/day (14 mg/kg/day for subjects with body weight <30 kg,
and 600 mg/day for those 17 years of age and older).
The safety profile observed in this study was comparable to the
known profile of LYRICA in prior epilepsy studies in pediatric and
adult patients. The most common adverse events observed with LYRICA
were dizziness, headache and somnolence.
About Epilepsy
Epilepsy is a chronic disorder characterized by recurrent,
unprovoked seizures and occurs in both adults and children.
Sixty-five million people worldwide have epilepsy. In the U.S.,
more than three million people, including 470,000 children are
living with epilepsy. Epilepsy is associated with increased
morbidity and mortality and can profoundly affect multiple daily
life activities. Primary generalized tonic-clonic seizures,
formerly referred to as grand mal seizures, are the most common
type of generalized seizures and involve loss of consciousness.
About LYRICA
LYRICA® is currently approved for various indications in more
than 130 countries and regions globally.
In the U.S., LYRICA is indicated to treat fibromyalgia, diabetic
nerve pain, spinal cord injury nerve pain and pain after shingles
in adults.
In the U.S., LYRICA is approved as adjunctive therapy for the
treatment of partial onset seizures in patients four years of age
and older. LYRICA is also indicated to treat partial onset seizures
in patients 4 years of age and older with epilepsy who take 1 or
more other drugs for seizures.
Please click here for the full prescribing information and
Medication Guide for LYRICA or visit http://www.lyrica.com/.
Important Safety
Information
LYRICA is not for everyone. LYRICA may cause serious,
even life threatening, allergic reactions. Stop taking LYRICA and
call your doctor right away if you have any signs of a serious
allergic reaction. Some signs are swelling of your face, mouth,
lips, gums, tongue, throat or neck or if you have any trouble
breathing, or have a rash, hives or blisters.
Drugs used to treat seizures increase the risk of suicidal
thoughts or behavior. LYRICA may cause suicidal thoughts or actions
in a very small number of people, about 1 in 500. Patients, family
members or caregivers should call the doctor right away if they
notice suicidal thoughts or actions, thoughts of self harm, or any
unusual changes in mood or behavior. These changes may include new
or worsening depression, anxiety, restlessness, trouble sleeping,
panic attacks, anger, irritability, agitation, aggression,
dangerous impulses or violence, or extreme increases in activity or
talking. If you have suicidal thoughts or actions, do not stop
LYRICA without first talking to your doctor.
LYRICA may cause swelling of your hands, legs and feet, which
can be serious for people with heart problems. LYRICA may cause
dizziness and sleepiness. You should not drive or work with
machines until you know how LYRICA affects you. Also, tell your
doctor right away about muscle pain or problems along with feeling
sick and feverish, or any changes in your eyesight including blurry
vision or if you have any kidney problems or get dialysis.
Some of the most common side effects of LYRICA are dizziness,
blurry vision, weight gain, sleepiness, trouble concentrating,
swelling of your hands and feet, dry mouth, and feeling “high.” If
you have diabetes, tell your doctor about any skin sores.
You may have a higher chance for swelling and hives if you are
also taking angiotensin-converting enzyme (ACE) inhibitors so tell
your doctor if you are taking these medications. You may have a
higher chance of swelling of your hands or feet or gaining weight
if you are also taking certain diabetes medicines. Do not drink
alcohol while on LYRICA. You may have a higher chance for dizziness
and sleepiness if you take LYRICA with alcohol, narcotic pain
medicines, or medicines for anxiety.
Before you start LYRICA, tell your doctor if you are planning to
father a child, or if you are pregnant, or plan to become pregnant.
Breastfeeding is not recommended while taking LYRICA. If you have
had a drug or alcohol problem, you may be more likely to misuse
LYRICA.
In studies, a specific type of blood vessel tumor was seen in
mice, but not in rats. The meaning of these findings in humans is
not known.
Do not stop taking LYRICA without talking to your doctor. If you
stop suddenly you may have headaches, nausea, diarrhea, trouble
sleeping, increased sweating, or you may feel anxious. If you have
epilepsy, you may have seizures more often.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world’s best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world’s premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
important to investors on our website at www.pfizer.com. In
addition, to learn more, please visit us
on www.pfizer.com and follow us on Twitter
at @Pfizer and @Pfizer_News, LinkedIn, YouTube and
like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is
as of May 24, 2019. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result
of new information or future events or developments.
This release contains forward-looking information about LYRICA
(pregabalin), including its potential benefits, that involves
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
the uncertainties inherent in research and development, including
the ability to meet anticipated clinical trial commencement and
completion dates and regulatory submission dates, as well as the
possibility of unfavorable study results, including unfavorable new
clinical data and additional analyses of existing clinical data;
the risk that clinical trial data are subject to differing
interpretations, and, even when we view data as sufficient to
support the safety and/or effectiveness of a product candidate,
regulatory authorities may not share our views and may require
additional data or may deny approval altogether; whether regulatory
authorities will be satisfied with the design of and results from
our clinical studies; decisions by regulatory authorities regarding
labeling and other matters that could affect the availability or
commercial potential of LYRICA; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2018 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results,” as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190524005356/en/
Media Contact:Steve Danehy(212)
733-1538Steven.Danehy@Pfizer.com
Investor Contact:Ryan Crowe(212)
733-8160Ryan.Crowe@Pfizer.com
Pfizer (NYSE:PFE)
Historical Stock Chart
From Apr 2024 to May 2024
Pfizer (NYSE:PFE)
Historical Stock Chart
From May 2023 to May 2024