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MALVERN, Pa., Aug. 19, 2014 /PRNewswire/ -- SCILEX Pharmaceuticals, Inc., a company engaged in the development and commercialization of late-stage pharmaceutical products for the treatment of pain, announced that it had formed a Scientific Advisory Board composed of four members: Dr. Jeff Gudin, Dr. Charles Argoff, Dr. Srinivas Nalamachu and Mr. Kip Vought.
SCILEX Chief Executive Officer Anthony Mack said the expertise of this board would greatly assist in the development and commercialization of future therapies. "The collective experience of our Scientific Advisory Board will help us produce best-in-class products for the treatment of pain, and stay ahead of industry competition," he commented.
Dr. Jeff Gudin is a recognized expert in pain management and has dedicated his career to promoting education in the area. For the past 14 years, Dr. Gudin has been Director of Pain Management and Palliative Care at Englewood Hospital and Medical Center, a Mt. Sinai University School of Medicine teaching affiliate in New Jersey. He is active in teaching and research, and has lectured internationally. Dr. Gudin serves as a consultant to state medical boards on challenging cases, and advises industry on analgesic products and risk management associated with opioids. He completed his residency in Anesthesiology at the Yale University School of Medicine and his fellowship at The Yale Center for Pain Management.
Dr. Charles Argoff is Professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Center at Albany Medical Center in Albany, New York. Dr. Argoff specializes in pain management and chronic headaches and has expertise in several types of pain treatments. He is also President of the American Academy of Pain Medicine Foundation. Dr. Argoff holds an M.D. from Northwestern University and completed his fellowship in development and metabolic neurology at the National Institutes of Health/National Institute of Neurological Disorders and Stroke in Bethesda, Maryland.
Dr. Srinivas Nalamachu has 20 years of experience in pain management and physical medicine, in addition to extensive industry research and consulting. He is President and Medical Director at the International Clinical Research Institute and Co-Director of the Pain Management Institute in Overland Park, Kansas. In the academic field, he is a Clinical Assistant Professor at the Department of Physical Medicine and Rehabilitation in Kansas. He has been a guest speaker at numerous international pain societies, forums and conferences, and acted as a consultant to a range of pharmaceutical companies. Dr. Nalamachu completed his medical education and internship at Kakatiya Medical College Teaching Hospitals in Warangal, India.
Mr. Kip Vought has more than twenty years of regulatory experience in drug development in U.S. and International markets. Since 2003, Mr. Vought has served as the Vice-President of Regulatory Affairs and Strategic Development for Regulus Pharmaceutical Consulting and Clinipace Worldwide with expertise in several therapeutic areas. He has taken multiple products from early development through the submission of market applications, and post-approval activities. He holds a B.S. in chemistry from the University of Miami.
About SCILEX Pharmaceuticals
SCILEX Pharmaceuticals, Inc., located in Malvern, PA, is an emerging specialty pharmaceutical company engaged in the development and commercialization of late-stage pharmaceutical products focused on the treatment of pain. The Company's vision is to become a world-class, global pharmaceutical company that delivers the next generation of innovative products. Leveraging its network of global relationships, the Company seeks to acquire high barrier-to-entry, late-stage products for development and commercialization. The Company's first product under development, Ztlido (lidocaine patch 1.8%), is a next-generation branded lidocaine patch formulation for the potential treatment of relieving the pain of postherpetic neuralgia, also referred to as "after-shingles pain." The FDA Division of Anesthesia and Analgesia Products recommended that the Company conduct a pivotal bioequivalence study of Ztlido versus Lidoderm® to support approval of Ztlido pursuant to a 505(b)(2) new drug application regulatory pathway. For more information visit www.scilexpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking statements regarding future events and the future performance of SCILEX Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management's current beliefs and expectations. These statements include, but are not limited to, statements that relate to SCILEX's business and its future, including SCILEX's ability to develop and commercialize products for the treatment of pain, that SCILEX may produce best-in-class products for the treatment of pain, and stay ahead of industry competition and any statements that relate to the intent, belief, plans or expectations of SCILEX or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Ztlido may not successfully bridge safety and efficacy to Lidoderm® through the planned bridging clinical study; successfully demonstrate suitable safety in the additional clinical studies; the possibility that SCILEX's future application to the FDA may not receive approval in a timely manner or at all; and SCILEX's dependence on third parties for clinical trials and manufacturing. SCILEX does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.
Ztlido is a trademark owned by SCILEX Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners. A proprietary name review by the FDA is planned.
For more information contact Will Pedranti:
SCILEX Pharmaceuticals, Inc.
© 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved.
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