By Drew Armstrong and Catherine Larkin - 2012-06-21T20:28:38Z Pfizer Inc. (PFE)s second-best selling drug, Lyrica, was approved by U.S. regulators today for use against pain caused by spinal cord injuries. The Food and Drug Administration cleared the expanded use of Lyrica, already backed to treat nerve pain from fibromyalgia, diabetic nerve pain and pain after shingles, New York-based Pfizer, said today in a statement. Pfizer estimates a potential patient population size of about 100,000 people. Until now, no FDA approved treatment options were available in the U.S. for people with neuropathic pain associated with spinal cord injury, a condition which can be extremely disabling, said Steven J. Romano, senior vice president and head of Pfizers medicines development group, Global Primary Care business unit, in the statement. Lyrica is Pfizers best-selling drug after cholesterol pill Lipitor, which lost patent protection in November. It had $3.39 billion in revenue last year. The treatment has patent protection until 2018, and Pfizer is working to expand its use. Pfizer declined less than 1 percent to $22.60 at the close in New York. To contact the reporters on this story: Drew Armstrong in New York at darmstrong17@bloomberg.net; Catherine Larkin in Denver at clarkin4@bloomberg.net To contact … Continue reading →

(RTTNews.com) - Pfizer Inc (PFE) Thursday announced that U.S. Food and Drug Administration, or the FDA, has granted approval for the use of Lyrica capsules for the management of neutopathic pain associated with spinal cord injury. The company stated that Lyrica has been given priority review designation by the FDA for the new indication. Pfizer further stated that neuropathic pain can be experienced above, at or below the level of the spinal cord injury, and is typically not confined to one area in the body. Approximately one-third of spinal cord injury patients report below-level neuropathic pain that is severe or excruciating. Patients may experience neuropathic pain associated with spinal cord injury as early as two weeks after injury and it may persist for up to 25 years. "Until now, no FDA approved treatment options were available in the U.S. for people with neuropathic pain associated with spinal cord injury, a condition which can be extremely disabling," said Steven J. Romano, MD, senior vice president and head, medicines development group, Global Primary Care Business Unit, Pfizer. "The approval of Lyrica for this indication is a significant milestone, exemplifying Pfizer's commitment to pursue scientific advancements that address unmet medical needs." For comments … Continue reading →

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today announced that CEO Frank Reynolds is scheduled to appear on WAWS-TV (FOX)/WTEV-TV (CBS) in Jacksonville, Florida on Monday June 25, 2012 at 7:45 am EDT. He is also scheduled to appear on KNSD-TV (NBC) in San Diego, California on Tuesday June 26, 2012 at 12:00pm PDT. InVivo Therapeutics has pioneered a new treatment using a biocompatible polymer-based scaffold to provide structural support to a damaged spinal cord. The device sparesspinal cordtissue from scarring while improving functional recovery after a traumatic SCI. In addition to the scaffold and its application for acute and chronic SCI, Reynolds will discuss new hydrogel technologies under development by InVivo. Our technology is a true platform that can be leveraged to create many neurotrauma products. InVivo is developing technologies to treat both acute and chronic injuries, as well as therapies for other nervous system conditions such as pain due to nerve compression and other peripheral nerve injuries. Were currently under review at FDA for our first SCI treatment, and we look forward to receiving approval to begin those human studies in 2012, said Reynolds. … Continue reading →

By Tess Stynes Pfizer Inc. (PFE) said the U.S. Food and Drug Administration approved its Lyrica drug for nerve pain for use by some spinal-cord-injury patients. The pharmaceutical giant said about 40% of 270,000 patients in the U.S. with spinal cord injuries suffer from neuropathic pain, which can hinder rehabilitation efforts. "Until now, no FDA approved treatment options were available in the U.S. for people with neuropathic pain associated with spinal cord injury, a condition which can be extremely disabling," said Steven J. Romano, head of the medicines development group at Pfizer's Global Primary Care Business Unit. In 12-week and 16-week studies, Lyrica was shown to significantly reduce nerve pain compared to a placebo. In addition, more patients taking Lyrica saw pain reduced by 30% and 50% , respectively, than those that received a placebo. In addition to efforts to refill product pipelines, pharmaceutical companies like Pfizer have been looking to expand uses of current drugs in an effort to head off the loss of patents on key drugs. Pfizer, which has posted weaker results lately amid the loss of U.S. market exclusivity for its anticholesterol drug Lipitor, has been studying the potential use of Lyrica to treat other diseases. … Continue reading →

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE) announced today that the U.S. Food and Drug Administration (FDA) approved the use of Lyrica (pregabalin) capsules CV for the management of neuropathic pain associated with spinal cord injury. Lyrica received a priority review designation for this new indication from the FDA. More than 100,000 patients approximately 40 percent of the 270,000 patients with spinal cord injury in the United States - suffer from this chronic, complex pain condition. Neuropathic pain associated with spinal cord injury can be severely debilitating and may significantly hinder rehabilitation and the ability to regain function. This milestone represents an important opportunity for physicians to more effectively manage the debilitating neuropathic pain that often accompanies spinal cord injury, said clinical study investigator Diana Cardenas, MD, MHA, professor and chair, department of rehabilitation medicine, University of Miami Miller School of Medicine and chief of service for rehabilitation medicine and medical director of Jackson Rehabilitation Hospital, Miami, Florida. Given the clinical challenges of investigating neuropathic pain in this patient population, any advancements in treatment are welcome by physicians and patients alike. An estimated 12,000 new spinal cord injury patients are diagnosed in the U.S. each year. There are a wide variety … Continue reading →