What are ORMALVI (dichlorphenamide) tablets?

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NOT ACTUAL PATIENT

ORMALVI is a proven treatment for Primary Periodic Paralysis. It can help you feel more confident by reducing the frequency and severity of your attacks.1

If you’re already familiar with dichlorphenamide, you can rest assured that ORMALVI is the same proven dichlorphenamide you are familiar with.1 It is accompanied by Cycle Vita™, a dedicated support platform for eligible* patients, which may help you live with confidence in managing your Primary Periodic Paralysis.

Find out more about patient support

What is dichlorphenamide?

Dichlorphenamide is the only medication approved by the FDA for the treatment of Primary Periodic Paralysis.2 It is well tolerated in patients with Primary Periodic Paralysis and its efficacy has been evaluated in two clinical studies.3

The first study compared dichlorphenamide with a placebo and found that:

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Patients taking dichlorphenamide had significantly fewer weekly episodes.4

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When patients taking dichlorphenamide did have episodes, they didn’t last as long.4

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Patients taking dichlorphenamide reported that their episodes were not as severe.4

A second study confirmed these results.2


How do you take ORMALVI?

ORMALVI is available in 50 mg tablets and is taken by mouth.3

The recommended starting dose of ORMALVI is 50 mg twice daily. This dosage may be increased or decreased at weekly intervals, based on individual response. The minimum recommended dose is 50 mg daily and the maximum recommended dose is 200 mg daily. Your response to ORMALVI should be evaluated after two months of therapy.3

Ormalvi Dischlorphenamide Tablets 50mg Bottle

What are the most common side effects of ORMALVI?

The most common adverse reactions (incidence at least 10% and greater than placebo) include:

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Paresthesia (typically tingling or pricking, often referred to as pins and needles)

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Cognitive disorder

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Dysgeusia (changes in taste)

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Confusional state3

The safety and effectiveness of ORMALVI in pediatric patients have not been established.3

For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

References

  1. Statland, J., et al (2017). Review of the Diagnosis and Treatment of Periodic Paralysis. Muscle & Nerve, [online] 57(4), pp.522–530. Available at: https://doi.org/10.1002/mus.26009 [Accessed 1 Nov. 2023].
  2. Greig. S. L., (2016). Drugs. Dichlorphenamide: A Review in Primary Periodic Paralyses. 76 (4): 501-507. Available at: https://doi.org/10.1007/s40265-016-0559-2 [Accessed 1 Nov. 2023].
  3. ORMALVI (dichlorphenamide). Prescribing Information. Cycle Pharmaceuticals Ltd.
  4. Sansone V.A., et al (2016). Randomized, placebo-controlled trials of dichlorphenamide in periodic paralysis. Neurology. 2016;86:1408-1416. Available at: https://pubmed.ncbi.nlm.nih.gov/26865514/ [Accessed 14 Feb. 2024]

*Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at +1 (888) 360-8482.