UCB Announces FINTEPLA® (fenfluramine) Oral Solution Is Now Descheduled and Is No Longer Listed as a Controlled Substance

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Apr 17, 2023, 07:14 ET

ATLANTA, April 17, 2023 /PRNewswire/ -- UCB (Euronext: UCB), a global biopharmaceutical company, today announced the U.S. Drug Enforcement Administration (DEA) has published a final rule stating that FINTEPLA oral solution is no longer subject to the Controlled Substances Act (CSA). This change is immediate.

The DEA rule means all federally controlled substance restrictions have been removed for FINTEPLA. UCB will now begin the process of updating the compendia in states where they hold licensure. Once this process is completed, in most cases prescribers will be able to write a prescription for a full year's supply versus the current limitation of six months. Additionally, the descheduling will enable prescribers to send a prescription to pharmacies electronically.

"We are pleased that FINTEPLA, which has a unique mechanism of action different from and complementary to other anti-seizure medications, has been descheduled and can help even more patients and families living with Dravet syndrome and Lennox-Gastaut syndrome manage the impact and burden of seizures," said Brad Chapman, Head of U.S. Epilepsy and Rare Syndromes, UCB. "Physicians will now have the option to issue an electronic prescription for FINTEPLA rather than requiring patients to obtain a written prescription to access this important therapy, which may be simpler and a better experience for all involved."

FINTEPLA is approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) in patients 2 years of age and older.¹ Following FDA approval, FINTEPLA was initially placed in Schedule IV of the CSA. Following receipt of this DEA rule, UCB has filed a labeling supplement with the FDA to remove Schedule IV designation from FINTEPLA.

"It is vitally important that our patient community has easy access to medicines that potentially reduce life-threatening and deadly seizures," said Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation. "We are pleased to hear of the descheduling of FINTEPLA, which will remove roadblocks to access and ease caregiver burden."

FINTEPLA was approved by the FDA for the treatment of DS in patients 2 years and older in June 2020 and for the treatment of LGS in patients 2 years and older in March 2022. FINTEPLA was developed by Zogenix, Inc., which was acquired by UCB in March 2022. The acquisition is consistent with UCB's sustainable patient value strategy and continued commitment to providing world-leading patient value to all people living with epilepsy, with an increasing focus on creating value and new solutions that address the unmet needs of people with certain specialized or rare types of epilepsy, where few or no options exist.

About Dravet Syndrome

Dravet syndrome is a rare, devastating and life-long form of developmental and epileptic encephalopathy that generally begins in infancy and is marked by frequent, treatment-resistant seizures, significant developmental, motor, and behavioral impairments, and an increased risk of mortality and sudden unexpected death in epilepsy (SUDEP). Most patients follow a course of developmental delay with cognitive, motor, and behavioral deficits that persist into adulthood. Dravet syndrome severely impacts quality of life for patients, families, and caregivers due to the high physical, emotional, caregiving, and financial burden associated with the disease.^2,3,4

About Lennox-Gastaut Syndrome

Lennox-Gastaut syndrome (LGS) is a severe childhood-onset developmental and epileptic encephalopathy characterized by drug-resistant seizures with high morbidity⁵ as well as serious impairment of neurodevelopmental, cognitive, and motor functions.⁶ LGS affects an estimated 30,000 to 50,000 patients in the U.S.⁷ LGS has far-reaching effects beyond seizures, including issues with communication, psychiatric symptoms, sleep, behavioral challenges, and mobility.⁸ Additionally, sudden unexpected death in epilepsy (SUDEP) is a major concern for people living with LGS.⁹

About FINTEPLA^® (fenfluramine)¹

In the U.S., FINTEPLA is approved for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older.

FINTEPLA is available in the U.S. through the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program. Further information is available at www.FinteplaREMS.com or by telephone at 1-877-964-3649.

Please see full Prescribing Information, including Boxed Warning, for additional important information on FINTEPLA.

INDICATION

FINTEPLA is a prescription medicine used to treat seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older.
It is not known if FINTEPLA is safe and effective in children less than 2 years of age.

IMPORTANT SAFETY INFORMATION

FINTEPLA can cause serious side effects, including:

1. Problems with the valves in the heart (valvular heart disease) and high blood pressure in the arteries of the lungs (pulmonary arterial hypertension) have been associated with fenfluramine, the active ingredient in FINTEPLA. Your healthcare provider will do a test called an echocardiogram to check your heart and to evaluate for high blood pressure in the arteries of the lungs before you start taking FINTEPLA, again every 6 months during treatment, and one time 3 to 6 months after you take your last dose of FINTEPLA.

Call your healthcare provider right away if you develop any of these signs and symptoms of heart or lung problems during treatment with FINTEPLA:

shortness of breath
chest pain
tiredness or weakness, especially with increased activity
sensations of a rapid, fluttering heartbeat (palpitations)
lightheadedness or fainting
irregular pulse
swollen ankles or feet
bluish color of your lips and skin (cyanosis)

Because of the risk of heart valve problems (valvular heart disease) and high blood pressure in arteries of lungs (pulmonary arterial hypertension), FINTEPLA is only available through a restricted program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program. Before you or your child receives FINTEPLA, your healthcare provider or pharmacist will make sure you understand how to take FINTEPLA safely. If you have any questions about FINTEPLA, ask your healthcare provider, visit www.FinteplaREMS.com, or call 1-877-964-3649.

2. Decreased appetite and decreased weight. Decreased appetite and decreased weight are both serious and common side effects of FINTEPLA in people with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS).

Your weight should be checked regularly during your treatment with FINTEPLA.
Your healthcare provider may need to make changes to your FINTEPLA dose if your weight decreases. In some cases, FINTEPLA may need to be stopped.

3. Sleepiness, sedation, and lack of energy (lethargy). These are both serious and common side effects of FINTEPLA in people with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS). Taking FINTEPLA with central nervous system (CNS) depressants, including alcohol, may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how FINTEPLA affects you.

4. Like all other antiepileptic drugs, FINTEPLA may cause suicidal thoughts or actions in a very small number of people (about 1 in 500).

Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying
new or worse anxiety
trouble sleeping (insomnia)
acting on dangerous impulses
attempts to commit suicide
feeling agitated or restless
new or worse irritability
an extreme increase in activity and talking (mania)
new or worse depression
panic attacks
acting aggressive, being angry or violent
other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
Keep all follow-up visits with your healthcare provider as scheduled.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

5. Do not stop taking FINTEPLA without first talking to your healthcare provider. Stopping a seizure medicine such as FINTEPLA can suddenly cause you to have seizures more often or seizures that do not stop (status epilepticus).

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not take FINTEPLA if you:

are allergic to fenfluramine or any of the ingredients in FINTEPLA. See below for a complete list of ingredients in FINTEPLA.
are taking or have stopped taking medicines called monoamine oxidase inhibitors (MAOIs) in the last 14 days. This may cause a serious or life-threatening problem called serotonin syndrome. If you are not sure whether or not you are taking one of these medicines, contact your healthcare provider.

Before taking FINTEPLA, tell your healthcare provider about all of your medical conditions, including if you:

have heart problems
have or have had weight loss
have or have had depression, mood problems, or suicidal thoughts or behavior
have kidney problems
have liver problems
are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant while taking FINTEPLA. You and your healthcare provider will decide if you should take FINTEPLA while you are pregnant.

If you become pregnant while taking FINTEPLA, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334 or go to www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.

are breastfeeding or plan to breastfeed. It is not known if FINTEPLA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking FINTEPLA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take FINTEPLA?

Read the Instructions for Use for information on the right way to use FINTEPLA.
Take FINTEPLA exactly as your healthcare provider tells you to take it.
Your healthcare provider will tell you how much FINTEPLA to take and when to take it.
FINTEPLA may be taken with or without food.
Measure your dose of FINTEPLA using the dosing syringe that is provided by the pharmacy. Do not use a household teaspoon or tablespoon.
FINTEPLA can be given through gastric and nasogastric feeding tubes.

What should I avoid while taking FINTEPLA?

Do not drive, operate heavy machinery, or do other dangerous activities until you know how FINTEPLA affects you. FINTEPLA may cause you to feel sleepy.

What are the possible side effects of FINTEPLA?

FINTEPLA may cause serious side effects, including:

See "FINTEPLA can cause serious side effects" above

Serotonin syndrome. Serotonin syndrome is a life-threatening problem that can happen in people taking FINTEPLA, especially if FINTEPLA is taken with certain other medicines including: anti-depressant medicines called SSRIs, SNRIs, TCAs, and MAOIs; tryptophan; lithium; antipsychotics; St. John's Wort; dextromethorphan; tramadol.
Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:

mental status changes such as seeing things that are not there (hallucinations), agitation, or coma
changes in blood pressure
tight muscles
fast heartbeat
nausea, vomiting, diarrhea
high body temperature
trouble walking

High blood pressure (hypertension). Hypertension is both a serious and common side effect. FINTEPLA can cause your blood pressure to increase even if you have never had high blood pressure before. Your healthcare provider will check your blood pressure while you are taking FINTEPLA.
Increased pressure in your eyes (glaucoma). Symptoms of glaucoma may include:

red eyes
seeing halos or bright colors around lights
nausea or vomiting
decreased vision
eye pain or discomfort
blurred vision

If you have any of these symptoms, call your healthcare provider right away.

The most common side effects of FINTEPLA when used to treat Dravet syndrome (DS) include:

decreased appetite
diarrhea
low energy
respiratory infection
decreased weight
fever
constipation
abnormal echocardiogram
sleepiness
problems with movement, balance, and walking
increased drooling
increased blood pressure
vomiting
falls
seizures that do not stop
weakness

The most common side effects of FINTEPLA when used to treat Lennox-Gastaut syndrome (LGS) include:

diarrhea
tiredness
vomiting
sleepiness
decreased appetite

These are not all the possible side effects of FINTEPLA. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1–800–FDA–1088.

Keep FINTEPLA and all medicines out of the reach of children.

General information about the safe and effective use of FINTEPLA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FINTEPLA for a condition for which it was not prescribed. Do not give FINTEPLA to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in FINTEPLA?
Active ingredient: fenfluramine hydrochloride
Inactive ingredients: cherry flavor, citric acid, ethylparaben, hydroxyethylcellulose, methylparaben, potassium citrate, sucralose, and water.
FINTEPLA contains no ingredient made from gluten-containing grain (wheat, barley, or rye) and contains not more than 0.1% of carbohydrates, which is from the cherry flavoring.

Please see full Prescribing Information, including Medication Guide, for additional Important Safety Information on FINTEPLA.

For further information, contact UCB:

Corporate Communications
Becky Malone, U.S. Media Relations
T +919.605.9600
[email protected]

Investor Relations
Antje Witte
T +32.2.559.9414
[email protected]

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,600 people in approximately 40 countries, the company generated revenue of € 5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.

Forward looking statements

This press release contains forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including but not limited to, the ability of UCB to successfully integrate the operations of Zogenix as planned or at all, estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: the global spread and impact of COVID-19, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB' efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems.

Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

UCB is providing this information, including forward-looking statements, only as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.

References

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Strzelczyk A, Schubert-Bast S. Expanding the treatment landscape for Lennox-Gastaut Syndrome: current and future strategies. CNS Drugs. 2021;35(1):61-83.
Arzimanoglou A, French J, Blume WT, et al. Lennox-Gastaut syndrome: a consensus approach on diagnosis, assessment, management, and trial methodology. Lancet Neurol. 2009;8(1):82-93.
LGS Foundation. LGS characteristics and major concerns survey. https://www.lgsfoundation.org/wp-content/uploads/2021/08/2019-PFDD-Caregiver-Survey-1.pdf. Accessed March 2022.
Mastrangelo M. Lennox-Gastaut Syndrome: a state of the art review. Neuropediatrics. 2017;48(3):143-151.
Harden C, Tomson T, et al. Practice guideline summary: Sudden unexpected death in epilepsy incidence rates and risk factors: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. 2017;88(17):1674-1680.