NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today positive top-line results of a
Phase 3 study examining the use of LYRICA® (pregabalin) Oral
Solution CV as adjunctive therapy for partial onset seizures in
pediatric epilepsy patients one month to less than four years of age.
Results showed that adjunctive treatment with LYRICA 14 mg/kg/day
resulted in a statistically significant reduction in seizure frequency
versus placebo, the primary efficacy endpoint. Treatment with LYRICA at
the lower dose (7 mg/kg/day) did not result in a statistically
significant reduction in seizure frequency versus placebo. The study was
a post-marketing requirement by the U.S. Food and Drug Administration
(FDA). LYRICA is not approved as adjunctive therapy for partial onset
seizures in pediatric epilepsy patients one month to less than four
years of age.
“The Phase 3 top-line results reinforce the efficacy and safety profile
of LYRICA for pediatric epilepsy patients,” said James M. Rusnak, M.D.,
Ph.D., Chief Development Officer, Internal Medicine, Pfizer Inc. “These
findings add to the data available for LYRICA in the pediatric patient
population for a complex and difficult-to-treat condition.”
The LYRICA Pediatric Epilepsy Program is composed of a total of six
studies in patients with epilepsy evaluating LYRICA as adjunctive
therapy, four of which have been completed and two of which are actively
enrolling. For more information, visit www.clinicaltrials.gov.
About the Study
This Phase 3 study was a double-blind, placebo-controlled, randomized,
parallel group, multi-center study that included 14 days of double-blind
adjunctive treatment. In this study, 175 pediatric patients with partial
onset seizures who were not adequately controlled with one to three
concomitant antiepileptic drugs were enrolled from 52 centers in 22
countries. Patients were randomized to placebo, or one of two fixed
doses of LYRICA divided three times daily: LYRICA 14 mg/kg/day or LYRICA
7 mg/kg/day in a 2:1:2 ratio.
The safety profile observed in this study is comparable to the known
profile of LYRICA in prior epilepsy studies in pediatric and adult
patients. No unexpected or new safety findings were reported in the
pediatric patients with partial onset seizures in this study. The most
common adverse events with LYRICA 14 mg/kg/day in this study were
somnolence, upper respiratory tract infection, and pneumonia. The most
common adverse events with LYRICA 7 mg/kg/day in this study were
somnolence, upper respiratory tract infection, and pyrexia. The most
common adverse events with placebo were upper respiratory tract
infection, vomiting, somnolence, and pyrexia.
Complete study results are expected to be submitted for publication in a
peer-reviewed medical journal. These data along with those of prior
studies will be submitted to the FDA for LYRICA pediatric exclusivity
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. Partial onset seizures are a
common seizure type in patients with epilepsy.
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 approved as adjunctive therapy for the treatment of partial
onset seizures in patients four years of age and older.
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.
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
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work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
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DISCLOSURE NOTICE: The information contained in this release is as of
May 17, 2018. 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 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 any such applications,
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 and, if approved, whether such indication
will be commercially successful; decisions by regulatory authorities
regarding labeling and other matters that could affect the availability
or commercial potential of LYRICA; uncertainties regarding whether
LYRICA will be granted pediatric exclusivity in the U.S.; and
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, 2017 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