NEW YORK--(BUSINESS WIRE)--
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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