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[Barbara.mj]

FDA Approves Expanded Indication For Pfizer's Lyrica - Update [PFE]


6/21/2007 5:36:46 PM As drug companies try to boost their earnings and refuel their product pipeline in the face of rising costs for research and development, there has been a recent upsurge in pharma companies trying to find new uses for the existing drugs.

The world's largest drug maker Pfizer Inc. (PFE) on Thursday announced that its nerve pain treatment Lyrica capsules CV has been approved by the FDA for the management of fibromyalgia. Lyrica is the successor to Pfizer's epilepsy drug, Neurontin.

Fibromyalgia syndrome is a chronic pain syndrome that refers to widespread pain, lasting at least three months. According to the American College of Rheumatology, between 2% and 4% of the U.S. population suffers from fibromyalgia.

In addition to pain, fibromyalgia syndrome patients often suffer from a combination of muscle stiffness, fatigue, disturbed sleep, restless legs and impaired memory and concentration.

The FDA approval of Lyrica for the management of fibromyalgia was based on the clinical trial results, in which Lyrica demonstrated rapid and sustained improvements in pain compared with placebo. In addition, patients taking Lyrica reported feeling better and there was a noticeable improvement in physical function.

Lyrica was approved by the FDA in 2004 for nerve pain associated with diabetes and shingles. Pfizer has been pursuing additional indications for Lyrica, such as anxiety disorder and fibromyalgia.

According to Pfizer, Lyrica's approval for fibromyalgia represents the company's eighth treatment to receive "priority review" status from the FDA over the past two and a half years. Pfizer's other priority reviews include Sutent for advanced kidney cancer and gastrointestinal stromal tumors, Chantix for smoking cessation and Lyrica's initial approval for the management of neuropathic pain associated with diabetic peripheral neuropathy.

A Priority designation sets the target date for the FDA to announce its decision on the drug within six months, rather than the usual 10-month to 12-month review period. Priority review status is granted by the FDA to products that are considered to be a potential therapeutic advance over existing therapies.

Lyrica has been prescribed to more than five million patients worldwide. In addition to being approved for the management of fibromyalgia in the United States, Lyrica is approved for the management of neuropathic pain associated with diabetic peripheral neuropathy and post-herpetic neuralgia, and for the adjunctive therapy for adult patients with partial onset seizures.

For the first quarter of 2007, Lyrica, fetched sales of $395 million representing a 106% growth over the year-ago period.

PFE closed Thursday's regular trade up $0.21 or 0.82% at $25.92 on a volume of 52.48 million shares.

http://www.rttnews.c...ws.asp?item=118

[danis]

Qui trovate la traduzione del post precedente:

http://www.cfsitalia...5&st=0&p=11120

Dear Barbara,
is it a great news or a worryingly one?
It means that another drug is helpful for fibromyalgia or that another company has decided not to invest anymore in research?
In Italy Lyrica is already used for fibromyalgia and I have heard that it is not well tolerate. I do not use it, do You?



Traduzione

Cara Barbara,
è una buna notizia o una notizia preoccupante? Significa che un altro farmaco è utile per la fibromialgia o che un'altra compagnia ha deciso di non investire ulteriormente nella ricerca?
In Italia il Lyrica è già usato per la fibromialgia ed ho sentito che non è ben tollerato. Io non lo uso, tu si?

[Barbara.mj]

Basically what this means is that the Food and Drug Administration has approved Lyrica to be prescribed for use by people with Fibromyalgia. It was used for other illnesses, but they have determined that it can help people with Fibromyalgia.

It was prescribed for me last year, but I decided not to take it because I was already taking Cymbalta and found that it was working for me. I also have been taking Neurontin for many years and don't think I have any side effects from it.

The Lyrica seems to have a lot of worrying side effects. I think we all have to be careful with what drugs we take.

[danis]

The Lyrica seems to have a lot of worrying side effects.  I think we all have to be careful with what drugs we take.

 

Me too, Barbara.
Maybe it is because I have poor faith on physicians or such pretended ones and even fewer on drug companies. Health business is one of the most disgusting because is made on patient skin.