Top-Line Data Show Lyrica Met Primary Endpoint in Clinical Trial as Adjunctive Therapy versus Levetiracetam in Patients with Partial Onset Seizures
Pfizer Inc. (NYSE: PFE) today announced top-line results for a Phase 3
study that showed Lyrica® (pregabalin) Capsules CV were as
effective as levetiracetam as an adjunctive therapy in adult epilepsy
patients experiencing refractory partial onset seizures.
The top-line results indicate that the study met its primary endpoint by
demonstrating that a comparable proportion of patients on Lyrica
achieved at least a 50 percent reduction in the 28-day seizure rate
during the maintenance phase relative to levetiracetam. The adverse
event profile in the study was consistent with that known for Lyrica.
Epilepsy is a chronic disorder in which seizures occur intermittently.
Partial onset seizures (simple, complex, and secondarily generalized
tonic-clonic) are the most common, particularly in adults, and often
require more than one antiepileptic medication. Patients with refractory
partial onset seizures are those patients whose seizures are not
completely controlled by medical treatment.
About the Study
The study was a randomized, double-blind, parallel-group, multicenter,
comparative, flexible-dose study to compare Lyrica (300, 450, 600
mg/day) to levetiracetam (1,000, 2,000, 3,000 mg/day) in reducing
partial onset seizure frequency in subjects with epilepsy.
Subjects included in the study were diagnosed with epilepsy with partial
onset seizures for at least two years, and were unresponsive to
treatment with at least two but no more than five prior antiepileptic
drugs (AEDs) and, at the time of the study enrollment, were on stable
dosages of one or two standard AEDs.
The primary efficacy endpoint was the responder rate, defined as the
proportion of subjects who had at least a 50 percent reduction in the 28
day seizure rate (all partial seizures) during the 12-week maintenance
phase, as measured from the 6-week baseline.
The most common adverse events reported in Lyrica-treated patients were
headache, dizziness, insomnia, somnolence, nausea and fatigue. The most
common adverse events reported for levetiracetam treated patients were
somnolence, dizziness and headache.
Results from this study will be submitted for presentation at upcoming
scientific congresses and for publication in a peer-reviewed medical
Lyrica is currently approved for various indications in 120 countries
and regions globally.
In the U.S., Lyrica has been approved by the Food and Drug
Administration for five indications. Lyrica was initially approved for
partial onset seizures in adults with epilepsy who take one or more
drugs for seizures. In 2007, Lyrica became the first FDA-approved
treatment for the management of fibromyalgia. Other indications include
neuropathic pain associated with diabetic peripheral neuropathy,
post-herpetic neuralgia (pain after shingles) and the management of
neuropathic pain associated with spinal cord injury (for which Lyrica
became the first FDA- approved treatment in 2012). Lyrica’s ongoing
clinical development program is focused on the significant unmet needs
of patients with certain chronic pain conditions.
In the European Union, Lyrica is approved for four indications:
peripheral and central neuropathic pain, generalized anxiety disorder in
adults, and partial seizures with or without secondary generalization in
adults with epilepsy.
In Japan, Lyrica is the only treatment approved for all three of the
following indications: post-herpetic neuralgia, neuropathic pain and
pain associated with fibromyalgia.
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).
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Pfizer Inc. Media: Jennifer Kokell, 212-733-2596 or Investors: Suzanne