Pfizer Reports Top-Line Results Of A Phase 3 Study Evaluating Pregabalin Controlled-Release Formulation As Adjunctive Treatment In Adult Patients With Partial Onset Seizures

pan>)--Pfizer Inc. (NYSE: PFE) today announced top-line results of a
double-blind, placebo-controlled, Phase 3 study evaluating both the 165
mg dose and the 330 mg dose of pregabalin controlled-release (CR)
formulation in adult patients with partial onset seizures with epilepsy.
These study results indicate pregabalin CR did not meet its primary
endpoint comparing the change in seizure frequency to placebo, although
both doses were well-tolerated.
“Lyrica immediate-release has a proven success record in patients with
epilepsy, and we look forward to understanding further the potential
role of a once-a-day pregabalin formulation.”
This study is one of three Phase 3 studies of the pregabalin CR
formulation, which will ascertain the potential use of pregabalin as a
once-a-day therapy. The other two studies are evaluating the pregabalin
CR formulation in fibromyalgia and post-herpetic neuralgia. Pfizer will
continue to further analyze these top-line results as well as the
top-line results of the other two studies.
While the study showed an observed improvement, it did not show a
statistically significant difference in seizure frequency, which we
believe may have been due to a higher-than-expected placebo response,
said Steven J. Romano, M.D., senior vice president, head, Medicines
Development Group, Global Primary Care Business Unit, Pfizer Inc.
Lyrica immediate-release has a proven success record in patients with
epilepsy, and we look forward to understanding further the potential
role of a once-a-day pregabalin formulation.
Epilepsy is a chronic disorder in which seizures occur intermittently.
Partial onset seizures (simple, complex, and secondarily generalized
tonic-clonic) are the most common. In the U.S., the immediate-release
formulation Lyrica (pregabalin) capsules CV has been used
as adjunctive therapy for partial onset seizures since its approval in
June 2005.
About the Study
The objective of the double-blind, randomized, parallel group,
multi-center study was to assess the efficacy and safety of pregabalin
CR as adjunctive treatment of partial onset seizures in adult patients
with epilepsy.
The study was conducted in a total of 18 countries at 66 sites. The
study included four phases: Phase 1 - an 8 week baseline phase during
which the baseline seizure rate was recorded; Phase 2 - a 2 week
double-blind dose escalation phase; Phase 3 - a 12 week double blind
maintenance phase where the dosage of study medication was fixed; and
Phase 4 - a 1 week taper phase at the conclusion of the study. Treatment
groups included pregabalin CR 165 mg/day, pregabalin CR 330 mg/day or
placebo at a 1:1:1 ratio. These pregabalin CR dose levels provided
exposure similar to 150 mg and 300 mg daily doses of currently available
Lyrica (pregabalin) immediate-release formulations.
The primary endpoint was the loge-transformed 28 day seizure
rate for all partial onset seizures collected during the double-blind
treatment phase compared to the 8 week baseline (screening) seizure
period.
The analysis of the primary endpoint, loge (28-days seizure
rate + 1), showed a non-significant result between pregabalin and
placebo for the pregabalin CR 330 mg group (p=0.0907). Responder rates,
defined as the percentage of patients with a 50% reduction in seizure
frequency from baseline, were 45.9%, 37.8% and 35.8% for the CR 330 mg,
CR 165 mg, and placebo groups, respectively, and highlight the high
placebo response observed in this study.
Both pregabalin CR 330 mg and pregabalin CR 165 mg were well tolerated
in this population. The tolerability and safety findings are consistent
with past pregabalin findings for patients with epilepsy, with
dizziness, weight increased and somnolence as the most frequently
reported adverse events in the study.
About Lyrica
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 any
indication.
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 www.lyrica.com.
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 worlds 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
worlds 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 16, 2012. 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 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
Pfizers 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.

Information Source: Business Wire