Pfizer Reports Top-Line Results Of A Phase 3 Study Evaluating Pregabalin
Controlled-Release As Treatment For Patients With Fibromyalgia
NEW YORK -- November 19, 2012
Pfizer Inc. (NYSE: PFE) today announced that top-line results of a
double-blind, Phase 3 study evaluating pregabalin controlled-release (CR)
formulation in patients with fibromyalgia indicate that pregabalin CR had a
statistically significant positive effect compared to placebo in the primary
endpoint, time to loss of therapeutic response (LTR). Fibromyalgia is a common
pain condition in the United States, affecting more than five million
Americans. It is characterized by chronic widespread pain and tenderness
lasting for three or more months.
This study is the second of three Phase 3 studies of the pregabalin CR
formulation to report top-line findings, which will ascertain the potential
use of pregabalin as a once-a-day therapy. The top-line results of the first
study in adults with partial onset seizures with epilepsy did not meet its
primary endpoint. The final study in post-herpetic neuralgia is ongoing.
Pfizer will analyze further results of all three studies once data are
“Collectively, the results of these controlled release studies will allow us
to better understand the potential of a once-a-day pregabalin treatment
regimen,” said Steven J. Romano, M.D., senior vice president, head, Medicines
Development Group, Global Primary Care Business Unit, Pfizer Inc. “Reducing
the number of times patients need to take their medicine per day while
maintaining the same efficacy and safety profile could potentially provide a
greater convenience and the potential to enhance treatment adherence and
About the Study
The objective of the double-blind, placebo-controlled, multi-center,
randomized withdrawal study was to assess the efficacy and safety of
pregabalin CR as treatment for patients with fibromyalgia.
The study was composed of 4 phases: baseline (1 week), single-blind (SB)
treatment (6 weeks), double-blind (DB) treatment (13 weeks), and a 1-week
double-blind taper. Study medication was administered once daily (QD)
immediately following the evening meal. During the SB phase, an optimal dose
of pregabalin CR (between 300 mg/day to 495 mg/day) was determined. In the DB
phase, patients were randomized to continued pregabalin CR treatment at the
optimized dose or to matching placebo.
A total of 441 subjects were enrolled into the SB phase from 49 sites in 4
countries (U.S., Canada, India, and Taiwan). Of the 441 subjects, 122 (28%)
completed SB, had ≥50% pain response (i.e., ≥50% reduction in pain compared to
baseline) and were randomized into DB. 122 subjects completed the single-blind
phase and were randomized to the double-blind phase. One subject discontinued
following randomization without receiving double-blind study medication, so
121 subjects received double-blind study medication and are included in the
full analysis set.
The primary endpoint, defined as the time to loss of therapeutic pain response
during DB (LTR; <30% pain response relative to the SB baseline mean pain or
withdrawal due to lack of efficacy or adverse events), occurred in 34 of 63
(54.0%) patients in the pregabalin group as compared with 41 of 58 (70.7%)
subjects in the placebo group. The median time from randomization to LTR was
58 days in the pregabalin group and 22 days in the placebo group. The
difference between the treatments was statistically significant (log-rank
Pregabalin CR was well tolerated and the safety profile was consistent with
the known profile for pregabalin (immediate release) in fibromyalgia patients.
Adverse events reported in 5 percent or more of subjects included dizziness,
somnolence, peripheral edema, insomnia, headache, fatigue, nausea, weight
increased, vision blurred, dry mouth, and disturbance in attention.
Lyrica^® is currently approved for various indications in 120 countries and
regions globally. Since its first approval from the FDA in 2004, Lyrica has
been 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. Antiepileptic drugs (AEDs) including Lyrica
increase the risk of suicidal thoughts or behavior in patients taking AEDs for
There have been post-marketing reports of angioedema and hypersensitivity with
Lyrica. Treatment with Lyrica may cause dizziness, somnolence, dry mouth,
edema and blurred vision. Other most common adverse reactions include weight
gain, constipation, euphoric mood, balance disorder, increased appetite and
thinking abnormal (primarily difficulty with concentration/attention).
For Lyrica prescribing information in the United States, please visit
Pfizer Inc.: Working together for a healthier world^®
At Pfizer, we apply science and our global resources to improve health and
well-being at every stage of life. We strive to set the standard for quality,
safety and value in the discovery, development and manufacturing of medicines
for people and animals. Our diversified global health care portfolio includes
human and animal biologic and small molecule medicines and vaccines, as well
as nutritional products and many of the world’s best-known consumer 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 the world’s
leading biopharmaceutical company, we also 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
about our commitments, please visit us at www.pfizer.com.
DISCLOSURE NOTICE: The information contained in this release is as of November
19, 2012. Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or future events or
This release contains forward-looking information about a potential additional
indication for Lyrica as a once-a-day treatment, including its potential
benefits, that involves substantial risks and uncertainties. Such risks and
uncertainties include, among other things, the uncertainties inherent in
research and development; decisions by regulatory authorities regarding
whether and when to approve any supplemental drug applications that may be
filed for such additional indication as well as their decisions regarding
labeling and other matters that could affect its availability or commercial
potential; 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, 2011 and in
its reports on Form 10-Q and Form 8-K.
MacKay Jimeson, 212-733-2324
Suzanne Harnett, 212-733-8009
Press spacebar to pause and continue. Press esc to stop.