FDA approves Lyrica for chronic pain condition
pharmafile | June 28, 2007 | News story | Sales and Marketing |Â Â Â
Pfizer's Lyrica has become the first treatment to be approved in the US for fibromyalgia, a widespread chronic pain condition.
Lyrica (pregabalin) was first launched in 2004 for the treatment of neuropathic pain and the control of epileptic seizures and FDA approval for fibromyalgia opens it up to a patient population of six million.
Dr Don Goldenberg, co-chair of the fibromyalgia guideline panel for the American Pain Society and professor of medicine at Tufts University, said: "This is an important day for people with fibromyalgia and a real opportunity to help physicians effectively manage this disorder.
"Having a medication approved for use in fibromyalgia, along with research advances, will go a long way to improving our understanding and treatment of this common disorder."
Characterised by chronic widespread pain that can be relentless, fibromyalgia is thought to result from neurological changes in how patients perceive pain, specifically a heightened sensitivity to stimuli that are not normally painful.
Lyrica works by binding to a specific protein within overexcited nerve cells and works to calm damaged nerves. This is thought to reduce the level of pain in patients suffering from fibromyalgia, although the exact mechanism of how Lyrica acts in fibromyalgia is not known.
Joe Feczko, Pfizer's chief medical officer, said: "Pfizer undertook a robust clinical development programme to evaluate Lyrica's effectiveness in treating a number of conditions where there is a huge unmet medical need.
"We are now seeing the dividends from our comprehensive research investment in the value that Lyrica will bring to patients suffering from fibromyalgia."
Pfizer has also received an approvable letter from the FDA for its new HIV/Aids treatment Maraviroc and the company said it is working to address outstanding questions and finalise the products labelling as soon as possible.
A potential first-in-class treatment, Maraviroc is under review as a therapy for treatment-experienced patients infected with CCR5-tropic HIV-1.
