Lyrica Receives CHMP Opinion For The Treatment Of GAD in Adults

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Lyrica Receives CHMP Opinion For The Treatment Of Generalized Anxiety

Disorder In Adults

http://www.medicalnewstoday.com/medicalnews.php?newsid=36813

Pfizer Inc said today that the Committee for Medicinal Products for

Human Use (CHMP) of the European Medicines Agency issued a positive

opinion recommending marketing authorization of Lyrica® (pregabalin),

a novel mechanism for the treatment of generalized anxiety disorder

(GAD) in adults.

The CHMP's positive recommendation will be reviewed by the European

Commission, which has authority to approve medicines for the European

Union. Pfizer anticipates a final decision from the Commission in the

coming months.

" Though GAD has been formally recognized by the medical community and

is frequently associated with high levels of distress and impairment,

the condition often goes undetected and untreated, " said Dr. ph

Feczko, Pfizer's chief medical officer. " It is estimated that only

one-third of those who suffer from this condition seek treatment

despite the significant impact on patient quality of life. We are

pleased that the CHMP has recognized the potential therapeutic

benefits of Lyrica in treating this serious medical condition. "

GAD, which affects an estimated five percent of people at some point

in their lives, is a psychiatric disorder characterized by excessive

worry as well as physical symptoms such as poor sleep, fatigue,

difficulty concentrating, irritability and restlessness. GAD affects

slightly more women than men, and symptoms are often chronic and

worsen during times of stress. GAD occurs more frequently in patients

with chronic medical illnesses, particularly in connection with pain

syndromes. The direct annual healthcare costs associated with GAD in

Europe are approximately $1.5 billion.

" Despite frequent visits to their doctor, GAD patients are still very

poorly treated. " said Dr. Stuart Montgomery, Professor of Psychiatry,

Imperial College School of Medicine, University of London. " The

psychological and physical effects of GAD disrupt work and personal

relationships and make it difficult to carry on with everyday

activities. Accurate diagnosis of GAD is important since prolonged

anxiety increases impairment and worsens the outcome of co-existing

physical illnesses. "

Lyrica has been approved for various neuropathic pain indications

including peripheral neuropathic pain, diabetic and postherpetic

neuropathic pain and adjunctive therapy for epilepsy in more than 50

countries outside of the United States. The most common adverse

events in Lyrica's clinical development program were dizziness and

somnolence. In the U.S., Lyrica® (pregabalin) capsules C-V is FDA

approved for the management of diabetic peripheral neuropathy,

postherpetic neuralgia and adjunctive treatment of partial onset

seizures. Developed by Pfizer, Lyrica is an alpha-2-delta ligand that

is believed to work by calming hyper-excited neurons.

www.pfizer.com