Our Therapeutic Focus

Strongbridge Biopharma is building a portfolio of vertical, therapeutically-aligned rare disease franchises

Rare Neuromuscular Franchise

The focus of our rare neuromuscular franchise is primary periodic paralysis. Our commercial effort is on KEVEYIS, the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis.

Primary periodic paralysis (PPP) is a genetic, neuromuscular disorder that can cause extreme muscle weakness and/or paralysis. It often interferes with daily activities and, as patients get older, it can lead to permanent muscle weakness. Primary periodic paralysis may be localized (“focal”) or more widespread (“generalized”), and it often goes underdiagnosed and/or undertreated. The 2 most common forms of this disorder are “hyperkalemic” and “hypokalemic” periodic paralysis.1-6

Learn more about primary periodic paralysis

Learn about KEVEYIS® (dichlorphenamide)

For KEVEYIS important safety information, please see full Prescribing Information (PDF).


Rare Endocrine Franchise

The focus of our rare endocrine franchise is on both Cushing’s syndrome and acromegaly. Our clinical effort is on developing new therapies to treat these rare endocrine disorders.

Endogenous Cushing’s syndrome, characterized by sustained elevated cortisol levels, presents unique clinical challenges to patients and healthcare providers.

Learn More About Endogenous Cushing’s Syndrome

Learn About SONICS, a Phase 3 Trial for Patients With Endogenous Cushing’s Syndrome

Acromegaly can be difficult to diagnose, and difficult to treat. Patients with acromegaly face numerous health issues related to their condition, and have limited treatment options available.

Learn More About Acromegaly

Learn About veldoreotide, a Somatostatin Analogue

The safety and efficacy of RECORLEV (levoketoconazole) and veldoreotide have not been established.


KEVEYIS® Indication

KEVEYIS® is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.7

Important Safety Information

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.

KEVEYIS is not for everyone. Do not take KEVEYIS if you:

  • Are on a high-dose aspirin regimen
  • Are allergic to sulfa-based drugs
  • Have liver, kidney, or certain lung conditions
  • Are pregnant, planning to become pregnant, or nursing
  • Are under 18 years old

Taking KEVEYIS may cause a drop in the amount of potassium (an electrolyte) in your body, which can lead to heart problems. Ask your doctor if you need to eat foods that contain high amounts of potassium while taking KEVEYIS.

Your body may produce too much acid or may not be able to remove enough acid from body fluids while taking KEVEYIS. Your doctor will run tests on a regular basis to check for signs of acid buildup and may reduce your dose or stop your treatment with KEVEYIS.

KEVEYIS may also increase the risk of falls, especially in elderly patients and patients taking high doses of KEVEYIS. Use caution when driving, operating machinery, or performing any other hazardous activities while taking KEVEYIS, as this medication may cause drowsiness.

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 more information, go to www.keveyis.com.

For additional KEVEYIS important safety information, please see full Prescribing Information (PDF).

References

  1. Grieg SL. Dichlorphenamide: a review in primary periodic paralyses. Drugs. 2016;76:501-507.
  2. Charles G, Zheng C, Lehmann-Horn F, Jurkatt-Rott K, Levitt J. Characterization of hyperkalemic periodic paralysis: a survey of genetically diagnosed individuals. J Neurol. 2013;260:2606-2613.
  3. Fontaine B, Phillips LH. A newly approved drug for a rare group of diseases: dichlorphenamide for periodic paralysis. Neurology. 2016;86:1366-1367.
  4. Bernard G, Shevell MI. Channelopathies: a review. Pediatr Neurol. 2008;38:73-85.
  5. National Institutes of Health. Hyperkalemic periodic paralysis. https://ghr.nlm.nih.gov/condition/hyperkalemic-periodic-paralysis. Accessed December 5, 2016.
  6. National Institutes of Health. Hypokalemic periodic paralysis. https://ghr.nlm.nih.gov/condition/hypokalemic-periodic-paralysis. Accessed December 5, 2016.
  7. KEVEYIS® (dichlorphenamide) [package insert]. Trevose, PA: Strongbridge Biopharma; 2015.

© 2017 Strongbridge Biopharma plc
STRONGBRIDGE BIOPHARMA is a trademark of Strongbridge Biopharma plc.
KEVEYIS® is a registered trademark licensed exclusively in the US to Strongbridge Biopharma plc.
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