New US product, ORMALVI™ (dichlorphenamide) tablets, launches for Primary Periodic Paralysis (PPP) treatment
08 Mayo 2024 - 10:52AM
Business Wire
Cycle Pharmaceuticals Limited (Cycle) is proud to announce the
launch of ORMALVI™ (dichlorphenamide) tablets, as a treatment
option for patients with hyperkalemic periodic paralysis (HyperPP),
hypokalemic periodic paralysis (HypoPP) and related variants,
approved by the US Food and Drug Administration (FDA).1
PPP is thought to affect about 5,000 people in the US.2
ORMALVI™ is being launched in partnership between Cycle and
Torrent Pharma Inc. (Torrent).
ORMALVI™ is a treatment option that allows patients with PPP to
remain on dichlorphenamide whilst accessing Cycle Vita™, a
dedicated support platform that provides individualized product
support* for patients.
“Patients with PPP typically have a difficult journey to
diagnosis. It can take years and involve numerous studies and
misdiagnoses. We’re fully aware of the unique challenges patients
face with this rare disorder. We want to provide them with the
support that they require to effectively manage their PPP. That’s
why we’re providing individualized support, including a Bridge
Program*, Co-pay Assistance Program* and a Patient Nutrition
Program* tailored to the patient’s type of PPP and known triggers,
to reinforce their clinic’s nutrition plan,” says Chikai Lai, SVP
& Chief Commercial Officer, Cycle.
ORMALVI™ is Cycle’s sixth commercial product to be launched in
the US, building on the launch of:
- NITYR® (nitisinone) Tablets in 2017
- SAJAZIR™ (icatibant) Injection in 2021
- JAVYGTOR™ (sapropterin dihydrochloride) Tablets for Oral Use
and Powder for Oral Solution in 2022
- TASCENSO ODT® (fingolimod) in 2023
- TIOPRONIN delayed-release tablets in 2024
To find out more about ORMALVI™, please visit www.ORMALVI.com
and find the Full Prescribing Information available at
www.ORMALVI.com/PI. To find out more about Cycle Vita, please visit
www.cyclevita.life or call +1 (888) 360-8482.
Important Safety Information
Indications
ORMALVI™ is an oral carbonic anhydrase inhibitor indicated for
the treatment of primary hyperkalemic periodic paralysis, primary
hypokalemic periodic paralysis, and related variants.
Important Safety Information
Contraindications
- Hypersensitivity to dichlorphenamide or other sulfonamides
- Concomitant use of ORMALVI™ and high dose aspirin
- Severe pulmonary disease, limiting compensation to metabolic
acidosis caused by ORMALVI™
- Hepatic insufficiency: ORMALVI™ may aggravate hepatic
encephalopathy
Warnings and Precautions
Fatalities associated with the administration of sulfonamides
have occurred because of adverse reactions including
Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant
hepatic necrosis, agranulocytosis, aplastic anemia, and other blood
dyscrasias. Discontinue ORMALVI™ at the first sign of skin rash or
any sign of immune-mediated or other life-threatening adverse
reaction. Carbonic anhydrase inhibitors, including ORMALVI™, can
cause metabolic acidosis, increasing the risk of salicylate
toxicity. Anorexia, tachypnea, lethargy, and coma have been
reported with concomitant use of dichlorphenamide and high-dose
aspirin. Concomitant use of ORMALVI™ and high-dose aspirin is
contraindicated. Use with caution and carefully monitor patients
receiving low-dose aspirin. ORMALVI™ increases potassium excretion
and can cause hypokalemia. Baseline and periodic measurements of
serum potassium during ORMALVI™ treatment are recommended. If
hypokalemia develops or persists, consider reducing the dose or
discontinuing ORMALVI™ and correction of potassium levels. ORMALVI™
can cause hyperchloremic non-anion gap metabolic acidosis.
Concomitant use of ORMALVI™ with other drugs that cause metabolic
acidosis may increase the severity of acidosis. Concomitant use of
ORMALVI™ in compensated patients with respiratory acidosis may lead
to respiratory decompensation. Baseline and periodic measurements
of serum bicarbonate during ORMALVI™ treatment are recommended. If
metabolic acidosis develops or persists, consider reducing the dose
or discontinuing ORMALVI™. ORMALVI™ increases the risk of falls;
risk is greater in the elderly and with higher doses. Consider dose
reduction or discontinuation of ORMALVI™ in patients who experience
falls. Based on animal data, ORMALVI™ may cause fetal harm. Use
during pregnancy only if the potential benefit justifies the
potential risk to the fetus. It is not known in humans whether
dichlorphenamide is excreted in human milk; exercise caution when
administered to a nursing woman.
Adverse Reactions:
The most common adverse reactions seen in clinical trials
(incidence ≥10% and greater than placebo) include paresthesias,
cognitive disorder, dysgeusia, and confusional state.
Drug Interactions:
Aspirin: anorexia, tachypnea, lethargy, and coma have been
reported with concomitant use of dichlorphenamide and high-dose
aspirin. The concomitant use of ORMALVI™ and high-dose aspirin is
contraindicated. ORMALVI™ should be used with caution in patients
receiving lower doses of aspirin.
For more detailed information, please refer to the full
Prescribing Information at www.ORMALVI.com/PI.
To report SUSPECTED ADVERSE REACTIONS, contact Cycle
Pharmaceuticals Ltd at 1-857-437-3969, or the FDA at:
1-800-FDA-1088 or www.fda.gov/medwatch.
US-DCP-2400017 (March 2024)
References
- ORMALVI™ (dichlorphenamide). Prescribing Information. Cycle
Pharmaceuticals Ltd.
- Sujatha Gurunathan (2023). Simply Stated: Research Updates in
Periodic Paralysis - Quest | Muscular Dystrophy Association
[online] Available at:
https://mdaquest.org/simply-stated-research-updates-in-periodic-paralysis
Accessed 23 Nov. 2023.
- Cavel-Greant, D., et al (2012). The impact of permanent muscle
weakness on quality of life in periodic paralysis: a survey of 66
patients. Acta myologica: myopathies and cardiomyopathies: official
journal of the Mediterranean Society of Myology, [online] 31(2),
pp.126–33. Available at:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3476862/ Accessed 1
Nov. 2023.
*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.
ORMALVI™ is a trademark of Torrent Pharma Inc. in the United
States. Cycle Vita™, SAJAZIR™ and JAVYGTOR™ are trademarks of Cycle
Pharmaceuticals Limited in the United States. NITYR® is a
registered trademark of Cycle Pharmaceuticals Ltd in the United
States. TASCENSO ODT® is a registered trademark of Handa
Neuroscience, LLC. ©2024 Cycle Pharmaceuticals Limited. All rights
reserved.
About Cycle Pharmaceuticals
Cycle Pharmaceuticals was founded in 2012 with the sole aim of
delivering drug treatments and product support to the underserved
rare disease patient community. Cycle focuses on rare metabolic,
immunological, and neurological genetic conditions. Within
neurological conditions, we focus on multiple sclerosis. Cycle is
headquartered in Cambridge, UK and has offices in Boston,
Massachusetts. For more information, please visit
www.cyclepharma.com and follow us on X, LinkedIn and Facebook.
About Torrent
Torrent Pharma is one of the leading Pharma companies in India.
Torrent is the pioneer in initiating the concept of niche marketing
in India and today is ranked amongst the leaders in therapeutic
segment of cardiovascular (CV), central nervous system (CNS),
gastro-intestinal (GI) and women healthcare (WHC). Torrent also has
significant presence in diabetology, pain management, gynaecology,
oncology and anti-infective segments.
Torrent Pharma is present in more than 40 countries. It is
ranked first amongst Indian Companies for having largest market
share in Brazil and Germany.
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