Pfizer Inc said today that
the European Commission has approved Lyrica(R) (pregabalin) for the treatment
of generalized anxiety disorder (GAD) in adults. In the European Union, it is
estimated that nearly 12 million patients suffer from GAD on a yearly basis
yet only one-third of these patients are properly diagnosed and even fewer
received effective treatment.
Lyrica's approval was based on five randomized double-blind clinical
trials involving over 2,000 patients. Data from a combination of five
placebo-controlled studies demonstrate that Lyrica provides rapid and
sustained efficacy for the treatment of GAD. As early as the first week of
treatment, Lyrica was shown to be significantly effective in providing relief
of both emotional symptoms, such as depressive symptoms and panic, as well as
physical symptoms, including headaches and muscle aches.
"GAD is much more than the normal anxiety people experience under times of
stress. It is a chronic, debilitating illness that can greatly disrupt an
individual's daily life, yet the disorder is under-treated," said Dr. Stuart
Montgomery, Professor of Psychiatry, Imperial College School of Medicine,
University of London. "Now that Lyrica is available, we have a new treatment
option to help alleviate a broad range of emotional and physical symptoms of
this prevalent condition."
Generalized anxiety disorder, which affects an estimated five percent of
people at some point in their lives, is a common and chronic psychiatric
disorder characterized by excessive worry and tension about everyday routine
life events and activities. Physical symptoms include poor sleep and fatigue,
while the emotional symptoms include difficulty concentrating, irritability
and restlessness. Generalized anxiety disorder occurs more frequently in
patients with other chronic medical illnesses, especially those associated
with pain conditions. The direct annual healthcare costs associated with GAD
in Europe are approximately $1.5 billion.
"Lyrica represents an innovative treatment advance for patients suffering
from generalized anxiety disorder," said Dr. Joseph Feczko, president of
Worldwide Development at Pfizer. "Early diagnosis and effective treatment is
critical since prolonged anxiety increases impairment and worsens the outcome
of co-existing illnesses."
The most common adverse events reported by patients were dizziness and
drowsiness. Most adverse events were mild to moderate in intensity and
generally dose related.
In the United States, Lyrica(R) (pregabalin) C-V capsules are approved for
the management of diabetic peripheral neuropathy, post herpetic neuralgia and
adjunctive treatment of partial onset seizures. Lyrica is an alpha-2-delta
ligand that is believed to work by calming hyper-excited neurons.
Developed by Pfizer, Lyrica has been approved for various neuropathic pain
indications including peripheral neuropathic pain, diabetic and post herpetic
neuropathic pain and adjunctive therapy for epilepsy in more than 60 countries
outside of the United States.
Pfizer Inc
http://www.pfizer.com
Lyrica Approved For The Treatment Of Generalized Anxiety Disorder (GAD) In Europe
Published
Published Tue 28 Mar 2006
