Our franchise-based model allows us to leverage company expertise—in both the clinical and commercial development realms—to provide a range of therapeutically‑aligned products.
In addition to our lead drug candidates, which have begun clinical development and have received orphan drug designation from the FDA and the European Medicines Agency, we have the U.S. and Canadian rights to MacrilenTM (macimorelin), the first and only FDA-approved oral test for the diagnosis of Adult Growth Hormone Deficiency.
Strongbridge Biopharma plc Enters into Agreement for Novo Nordisk to Acquire the U.S. and Canadian Rights to Macrilen™. Click here for more details.
We also have the U.S. rights to KEVEYIS® (dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis. KEVEYIS and Macrilen have both been granted orphan drug exclusivity in the United States.
Primary Periodic Paralysis (FDA-approved; FDA orphan drug designation)
Adult Growth Hormone Deficiency diagnosis (FDA-approved; FDA orphan drug designation)
Endogenous Cushing's syndrome (FDA and EMA orphan drug designation)
Acromegaly (FDA and EMA orphan drug designation) and potential additional applications in other conditions amenable to somatostatin receptor activation, such as Cushing's disease and neuroendocrine tumors
KEVEYIS is proven to decrease the number, severity, and duration of attacks in patients with Primary Periodic Paralysis.1,2 Read more about KEVEYIS.
Macrilen, an oral ghrelin agonist, is indicated for the diagnosis of adult growth hormone deficiency (AGHD). Read more about Macrilen.
RECORLEV (levoketoconazole) is currently being evaluated in LOGICS and SONICS, phase 3 trials for patients with endogenous Cushing’s syndrome. Originally developed as a potential treatment for patients currently with diabetes, Strongbridge pivoted the focus of clinical development for RECORLEV (levoketoconazole) to treatment of endogenous Cushing’s syndrome in 2012. Read more about RECORLEV (levoketoconazole).
Veldoreotide extended release: A pre-clinical next-generation somatostatin analog being investigated for the treatment of acromegaly and potential additional applications in other conditions amenable to somatostatin receptor activation.
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.
What is Macrilen?
Macrilen (pronounced ma-kri-len) (macimorelin) is a prescription oral solution that is used to test for adult growth hormone deficiency (AGHD).
What should you know about Macrilen?
What are the most common side effects with Macrilen?
The most common side effects were changed sense of taste, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, excessive sweating, sore nose and throat, and decreased heart rate.
These are not all of the possible side effects of Macrilen. 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.
© 2019 Strongbridge Biopharma plc
STRONGBRIDGE BIOPHARMA® is a registered trademark of the Strongbridge Biopharma plc. companies, which include Strongbridge Ireland Limited and Strongbridge U.S. Inc.
KEVEYIS® is a registered trademark licensed exclusively in the U.S. to Strongbridge Biopharma plc.
Macrilen™ is a trademark of Aeterna Zentaris GmbH, licensed exclusively in the U.S. and Canada to Strongbridge Ireland Limited.
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