Pfizer has submitted data from a new study of Lyrica to US regulators and is looking to expand the drug’s label so that it becomes the first treatment for fibromyalgia to be approved.
Fibromyalgia is one of the most common chronic, widespread pain conditions, the firm noted, affecting more than six million Americans, and is thought to result from neurological changes in how patients perceive pain. It is usually accompanied by poor sleep, stiffness, depression and fatigue and can hamper a patient’s ability to work.
The New York-based drugs giant presented data from the study at the American Academy of Neurology annual meeting in Boston and it revealed that significantly more patients treated with Lyrica (pregabalin), which is currently approved for epilepsy and neuropathic pain reduced their pain by 50% or more compared with placebo. Clinically, this outcome would equate to a patient with severe pain reporting a reduction to mild to moderate pain, Pfizer noted.
The 14-week study included 745 patients with fibromyalgia who were randomised to receive Lyrica at 300mg, 450mg or 600mg or placebo daily. 30% of patients taking the 600 mg dose said their pain was reduced by half or better compared with 27% at 450 mg and 24% at the lowest dose. Of those taking a placebo, 15% reported pain reduction of 50% or greater.
“A growing body of evidence is defining the biology behind fibromyalgia that causes such devastating and constant pain,” said Dr Jon Russell, one of the study’s authors. “A reduction in pain is critical for people living with this condition [and] with positive new data and new treatments on the horizon, the outlook for people with fibromyalgia has never been better,” he added.
The results of these data have been submitted to the US Food and Drug Administration as part of a supplemental New Drug Application for Lyrica, which has been used by more than five million patients worldwide since it rolled out in the USA in September 2005. First-quarter sales this year were up 106% to $395 million.
– Meantime Pfizer has launched an online site to provide up-to-date, user-friendly information on the status of its US post-marketing commitments, saying that the initiative “is the first of its kind for a pharmaceutical company”.
The FDA first posted a database of all the industry’s post-marketing commitments on its website in 2003 but Pfizer says its new site expands the information available, presented with user-friendly search functions, a glossary of terms and frequently asked questions.