Pfizer Inc. (NYSE:PFE) announced today top-line results of a
Phase 3 study evaluating the efficacy and safety of LYRICA®
(pregabalin) Capsules CV in adults with chronic post-traumatic
peripheral neuropathic pain. The study did not meet its primary
efficacy endpoint.
The study was conducted as a 15-week, double-blind,
placebo-controlled, parallel group study with a primary objective
to evaluate the efficacy of pregabalin in the treatment of chronic
post-traumatic peripheral neuropathic pain. The primary efficacy
endpoint was mean pain reduction from baseline compared with
placebo based on pain scores from patients’ daily pain diaries. The
safety profile observed in this study was consistent with that
known for pregabalin. The most common adverse events with
pregabalin in this study were dizziness, somnolence, nausea and
fatigue.
There is currently no treatment approved by the U.S. Food and
Drug Administration for post-traumatic neuropathic pain.
Complete study results will be shared on clinicaltrials.gov.
About LYRICA®
LYRICA® is currently approved for various indications in
more than 130 countries and regions globally.
LYRICA is approved for five indications in the U.S., of which
four are in the therapeutic area of pain. These indications include
neuropathic pain associated with diabetic peripheral neuropathy,
post-herpetic neuralgia (pain after shingles), neuropathic pain
associated with spinal cord injury, fibromyalgia and 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.
Important Safety Information
LYRICA is not for everyone. LYRICA may cause serious,
even life threatening, allergic reactions. Patient should stop
taking LYRICA and call their doctor right away if they have any
signs of a serious allergic reaction. Some signs are swelling of
face, mouth, lips, gums, tongue, throat or neck, trouble breathing,
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 patients have suicidal thoughts or actions, they should
not stop LYRICA without first talking to their doctor.
LYRICA may cause swelling of hands, legs and feet, which can be
serious for people with heart problems. LYRICA may cause dizziness
and sleepiness. Patients should not drive or work with machines
until they know how LYRICA affects them. Patients should tell their
doctor right away about muscle pain or problems along with feeling
sick and feverish, or any changes in eyesight including blurry
vision or if they 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 hands and feet, dry mouth, and feeling “high”. Patients
with diabetes should tell their doctor about any skin sores.
Patients may have a higher chance for swelling and hives if they
are also taking angiotensin converting enzyme (ACE) inhibitors and
should tell their doctor if they are taking these medications.
Patients may have a higher chance of swelling of hands or feet or
gaining weight if they are also taking certain diabetes medicines.
Patients should not drink alcohol while on LYRICA. They may have a
higher chance for dizziness and sleepiness if they take LYRICA with
alcohol, narcotic pain medicines, or medicines for anxiety.
Before starting LYRICA, patients should tell their doctor if
they are planning to father a child, or are pregnant, plan to
become pregnant, or are breast-feeding. If patients have had a drug
or alcohol problem, they 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.
Patients should not stop taking LYRICA without talking to their
doctor. If they stop suddenly they may have headaches, nausea,
diarrhea, trouble sleeping, increased sweating, or may feel
anxious. Patients with epilepsy 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, Pfizer has worked to make a difference for
all who rely on us. To learn more, please visit us at
www.pfizer.com.
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version on businesswire.com: http://www.businesswire.com/news/home/20151125005311/en/
Pfizer Inc.Media:Steve Danehy,
212-733-1538Steven.Danehy@pfizer.comorInvestors:Ryan Crowe,
212-733-8160Ryan.Crowe@pfizer.com
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