The current clinical focus of our rare endocrine franchise is on developing new therapies to treat rare endocrine disorders, such as Cushing's syndrome. Our lead product candidate is RECORLEV® (levoketoconazole), an investigational cortisol synthesis inhibitor for endogenous Cushing's syndrome.
Endogenous Cushing’s syndrome, characterized by sustained elevated cortisol levels, presents unique clinical challenges to patients and healthcare providers.
The safety and efficacy of RECORLEV (levoketoconazole) and veldoreotide have not been established.
The focus of our rare neuromuscular franchise is Primary Periodic Paralysis (PPP). Our commercial effort is on KEVEYIS® (dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of PPP.
Primary Periodic Paralysis (PPP) is a spectrum of rare and chronic, genetic disorders that cause recurrent, progressive, and debilitating attacks of muscle weakness and temporary paralysis.1,2 PPP often interferes with daily activities as attacks are unpredictable and vary in severity and duration. As they age, patients may experience permanent muscle weakness.3 Symptoms are often nonspecific with varying clinical presentations; PPP is not easily diagnosed and may go untreated for many years.3,4 Although there are related variants, the most common forms are hyperkalemic and hypokalemic PPP.5-9
What is KEVEYIS?
KEVEYIS (pronounced keh-VAY-iss) (dichlorphenamide) is a prescription drug used to treat primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and other similar diseases.
What should you tell your healthcare provider before taking KEVEYIS?
Tell your doctor if you are allergic to dichlorphenamide or other sulfa drugs; if you take high doses of aspirin, or if you have lung or liver disease; if you are pregnant, plan to become pregnant, or are breastfeeding or plan to breastfeed.
What should you know about KEVEYIS?
What are the most common side effects with KEVEYIS?
The most common side effects are a feeling of numbness, tingling or burning (“pins and needles”) in the toes, feet, hands or fingers; trouble with memory or thinking; feeling confused; and unpleasant taste in the mouth.
These are not all of the possible side effects of KEVEYIS. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Strongbridge Biopharma plc announces levoketoconazole Phase 3 SONICS data published in The Lancet Diabetes & Endocrinology.
Learn more about this first and only FDA-approved treatment for patients with a rare neuromuscular disease.
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© 2020 Strongbridge Biopharma plc
STRONGBRIDGE BIOPHARMA® is a registered trademark of the Strongbridge Biopharma plc. companies, which include Strongbridge Dublin Limited and Strongbridge U.S. Inc.
KEVEYIS® is a registered trademark licensed exclusively in the U.S. to Strongbridge Biopharma plc.
MLR-0010 V18 05/2020