NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today positive top-line results of a
study that evaluated the use of LYRICA® (pregabalin) Capsules CV and
Oral Solution CV as adjunctive therapy for pediatric epilepsy patients
four to 16 years of age with partial onset seizures. Results showed that
adjunctive treatment with LYRICA 10 mg/kg/day resulted in a
statistically significant reduction in seizure frequency versus placebo,
the primary efficacy endpoint. Treatment with LYRICA 2.5 mg/kg/day
resulted in a numerical reduction in seizure frequency, which was not
statistically significant. LYRICA is not approved as adjunctive therapy
for pediatric epilepsy patients with partial onset seizures.
Information and Factors That May Affect Future Results”
“At Pfizer we believe it is important to continue to study our medicines
in relevant populations,” said Rory O’Connor, MD, Chief Medical Officer,
Internal Medicine, Pfizer Inc. “Epilepsy remains a common and
debilitating condition worldwide, and these results make a substantial
contribution to the body of evidence for LYRICA in the pediatric
The LYRICA Pediatric Epilepsy Program is composed of a total of six
studies in patients with epilepsy evaluating LYRICA as adjunctive
therapy, three of which have been completed and three are actively
enrolling. For more information, visit www.clinicaltrials.gov.
About the Study
This Phase 3 study was a 12-week double-blind, placebo-controlled,
randomized, parallel group, multi-center study including two fixed
LYRICA doses. The study was conducted at 76 sites in 18 countries with
295 subjects four to 16 years of age. Subjects were randomized to
placebo, LYRICA 2.5 mg/kg/day or LYRICA 10 mg/kg/day.
The safety profile observed in this study was consistent with that known
for LYRICA in adults. No unexpected or new safety findings were reported
in the pediatric patients with POS in this study. The most common
adverse events with LYRICA 10 mg/kg/day in this study were somnolence,
weight increase, increased appetite and pyrexia. The most common adverse
events with LYRICA 2.5 mg/kg/day were somnolence, upper respiratory
tract infection, nasopharyngitis and cough.
Complete study results are expected to be submitted for presentation at
an upcoming scientific congress and for publication in a peer-reviewed
Epilepsy is a chronic disorder characterized by recurrent, unprovoked
seizures and occurs in both adults and children. Sixty-five million
people worldwide have epilepsy. One in 26 individuals in the U.S. will
develop epilepsy at some point in their lifetime. About three million
people in the U.S. are living with epilepsy, of which approximately 10
percent or 300,000 are pediatric patients. Partial onset seizures are
the most common seizure type.
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.
LYRICA is also indicated to treat partial onset seizures in adults with
epilepsy who take one or more 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
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
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DISCLOSURE NOTICE: The information contained in this release
is as of December 1, 2016. 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, 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, without limitation, the ability to meet anticipated trial
commencement and completion dates and regulatory submission dates, as
well as the possibility of unfavorable clinical trial results, including
unfavorable new clinical data and additional analyses of existing
clinical data; whether and when any applications for any potential new
indication for LYRICA may be filed with regulatory authorities in any
jurisdictions; whether and when regulatory authorities in any
jurisdictions may approve such applications and/or any other
applications that are pending or may be filed for LYRICA, which will
depend on the assessment by such regulatory authorities of the
benefit-risk profile suggested by the totality of the efficacy and
safety information submitted; 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, 2015 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