Thursday, June 21, 2012

FDA green lights Pfizer’s blockbuster drug Lyrica for spinal injury patients


 6.21.12 | Stephanie Baum  The U.S. Food and Drug Administration has approved the expanded use of Pfizer’s (NYSE:PFE) blockbuster pain medication Lyrica for neuropathic pain associated with spinal injury, according to a company statement. It received the approval to treat the chronic pain condition under the FDA’s priority review designation for the new indication. There are an estimated 270,000 people with spinal cord injuries in the U.S., with 40 percent or 100,000 patients experiencing neuropathic pain with their condition, according to a company statement. The drug will help physicians more effectively manage debilitating neuropathic pain that can accompany spinal cord injuries, said Dr. Diana Cardenas, the clinical study investigator and professor and chair of the department of rehabilitation medicine atUniversity of Miami Miller School of Medicine. Lyrica stands to be Pfizer’s next top-selling blockbuster drug. Last year, Lyrica had sales of $3.6 billion, second only to Lipitor with $9.5 billion, a figure it’s not likely to match again since Pfizer’s exclusive patent for Lipitor expired at the end of last year.  In addition to the latest indication, Lyrica is currently used to manage nerve pain associated with shingles and pain resulting from nerve damage from diseases like diabetes, and to manage fibromyalgia. Pfizer’s exclusivity for Lyrica is due to expire in 2018 in the U.S., although it will continue in Japan until 2022. 

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