EMERYVILLE, California – August 9, 2021 – Zogenix, a global biopharmaceutical company developing rare disease therapies, today announced it will donate $50,000 to be equally divided between the Dravet Syndrome Foundation and Epilepsy Foundation, in support of the work they do for patients and families in the United States impacted by a rare, severe form of epilepsy called Dravet syndrome. The Dravet syndrome community helped raise these donations by participating in the FINTEPLA Photo Diary, a charitable campaign and contest hosted by Zogenix to celebrate everyday moments in life with fewer seizures.
The everyday moments honored in the campaign and contest are meaningful for the Dravet syndrome community because those with Dravet syndrome may have multiple seizures per day. Dravet syndrome is marked by these unpredictable and often prolonged seizures and significant developmental, motor and behavioral impairments.
Hundreds of photos were submitted as part of the Photo Diary contest, and Zogenix committed to donating $25 for each “Like” or share of a photo. The three families whose submissions in the Photo Diary campaign received the most “Likes” and shares received prizes as the contest winners -- including a grand prize of a professional photo shoot to capture more everyday moments. Two runner-up families received iPads.
FINTEPLA (fenfluramine) oral solution, CIV, is a prescription medicine approved by the US Food and Drug Administration (FDA) in 2020 to treat seizures associated with Dravet syndrome in patients 2 years of age and older. In a clinical study, when added to other antiepileptic medicines, FINTEPLA was shown to reduce monthly seizures by 79% on average in patients taking 0.7 mg/kg/day of FINTEPLA, compared to a 16% reduction in patients taking other antiepileptic medicines and placebo. Due to the risk of heart valve problems and pulmonary arterial hypertension, FINTEPLA is available only through the FINTEPLA REMS Program in the US. Please read Important Safety Information, including Boxed Warning below. More information about FINTEPLA in the U.S. can be found at Fintepla.com.
“These everyday moments in life with fewer seizures have been a blessing. We were motivated to share our photos for the opportunity to give back to the community and show our experience with FINTEPLA,” said Erika, the caregiver whose submission won the grand prize. “We’re proud to celebrate these favorite moments with our community and honored to represent this inspiring campaign as the contest Grand Prize winner. It was truly amazing to see the response from the community and to participate in a campaign that has raised $50,000 for organizations that help families like ours.”
“We appreciate community initiatives like the Photo Diary that celebrate the Dravet syndrome community and the progress we are making together in treating Dravet syndrome. The powerful images families shared remind us of how meaningful moments between seizures are, and the difference they make for families living with Dravet syndrome and for us all,” said Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation. “We’d like to thank the Dravet syndrome community for participating in the Photo Diary, and for raising $25,000 to support our organization’s ongoing mission to one day cure this rare, intractable form of epilepsy.”
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 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:
Because of the risk of heart valve problems and 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.
3. Sleepiness, sedation, and lack of energy (lethargy). These are both serious and common side effects of FINTEPLA. 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:
How can I watch for early symptoms of suicidal thoughts and actions?
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:
Before taking FINTEPLA, tell your healthcare provider about all of your medical conditions, including if you:
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?
What should I avoid while taking FINTEPLA?
What are the possible side effects of FINTEPLA?
FINTEPLA may cause serious side effects, including:
If you have any of these symptoms, call your healthcare provider right away.
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).
Media Inquiries about the FINTEPLA Photo Diary Campaign
Public Relations, Syneos Health Communications
+1 (631) 697-8310 | [email protected]