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Strongbridge Biopharma plc Launches the Uncovering Periodic Paralysis Genetic Testing ProgramDUBLIN, Ireland and TREVOSE, Pa., Sept. 25, 2017 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq:SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced the launch of a genetic testing program for hyperkalemic or hypokalemic periodic paralysis. Primary Periodic Paralysis is a rare inherited disorder characterized by recurrent, progressive, and debilitating episodes of muscle weakness and temporary paralysis that affects approximately 4,000 to 5,000 diagnosed individuals in the United States. “We are pleased to launch the Uncovering Periodic Paralysis genetic testing program, which builds upon our current suite of patient and physician services already being offered through the Strongbridge CareConnection Program,” said Matthew Pauls, president and chief executive officer of Strongbridge Biopharma. “Primary Periodic Paralysis patients have historically been underserved, and we are proud to offer them robust support from Strongbridge’s patient- and physician-focused programs. Additionally, given the early market interest in KEVEYIS® (dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis, and to better serve the needs of patients and the physicians who treat them, we are expanding our 12-person field force team to 21 employees by early November.” Uncovering Periodic Paralysis is a no-cost program that offers genetic testing for those who qualify. Although genetic testing can confirm a suspected diagnosis, the absence of a genetic alteration does not preclude diagnosis of this disease. The Periodic Paralysis Panel includes testing of the three genes that are most commonly-associated with periodic paralysis: SCN4A, CACNA1S, and KCNJ2. “Strongbridge’s genetic testing program will provide an early diagnostic testing measure for Primary Periodic Paralysis, a serious neuromuscular disease that sometimes takes up to 20 years to accurately diagnose,” said Deborah Cavel-Greant, president, Periodic Paralysis International. “The availability of this test may help relieve patients and their families of a significant emotional burden and pave the way for more timely and effective treatment.” “There is a growing awareness of periodic paralysis and access to tests such as this may help shorten the diagnostic journey for patients,” said Steve Cannon M.D., PhD, neurologist and professor of Physiology at UCLA. “Access to more reliable genetic testing will empower medical professionals with the right information to facilitate improved clinical management of the disease.” Periodic Paralysis Panel Eligibility
Family Variant Testing
For more information about the program, please visit: UncoveringPeriodicParalysis.com. About Strongbridge Biopharma Strongbridge Biopharma is a commercial-stage global biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Strongbridge's first commercial product is KEVEYIS® (dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis. KEVEYIS has orphan drug exclusivity status in the U.S. through August 7, 2022. In addition to establishing this neuromuscular disease franchise, the Company has a clinical-stage pipeline of therapies for rare endocrine diseases. Strongbridge's lead compounds include RECORLEV™ (levoketoconazole), a cortisol synthesis inhibitor currently being studied for the treatment of endogenous Cushing's syndrome, and veldoreotide, a next-generation somatostatin analog being investigated for the treatment of acromegaly, with potential additional applications in Cushing's syndrome and neuroendocrine tumors. Both RECORLEV and veldoreotide have received orphan designation from the U.S. Food and Drug Administration and the European Medicines Agency. For more information, visit www.strongbridgebio.com. KEVEYIS® (dichlorphenamide) is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants. In clinical studies, the most common side effects of KEVEYIS were a numbness or tingling, difficulty thinking and paying attention, changes in taste, and confusion. These are not all of the possible side effects that you may experience with KEVEYIS. Talk to your doctor if you have any symptoms that bother you or do not go away. You are encouraged to report side effects to Strongbridge Biopharma at 1-855-324-8912, or to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch/. For additional KEVEYIS important safety information and the full prescribing information visit www.keveyis.com. Forward-Looking Statements Contacts: Corporate and Media Relations Investor Relations Europe: USA |