Zogenix Presents New Data from a Study Highlighting the Impact of Treatment with FINTEPLA? (Fenfluramine) Oral Solution on Dravet Syndrome Patients, Caregivers, and Families at Virtual AAN 20
EMERYVILLE, Calif., April 16, 2021 (GLOBE NEWSWIRE) -- ?Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced new findings from an investigator-initiated study designed to assess caregivers? perspectives on the long-term seizure- and non-seizure-related benefits of FINTEPLA??(fenfluramine) on patients with Dravet syndrome, a rare, severe epilepsy, and on their caregivers and families. Data from the study is being presented during the virtual American Academy of Neurology (AAN) Annual Meeting, April 17-22, 2021.
?The impact of Dravet syndrome on the lives of the diagnosed child and the family members who care and worry about their loved one can be severe and unrelenting,? said Mark Jensen, Ph.D., Vice Chair for Research in Rehabilitation Medicine at UW Medicine, Professor of Rehabilitation Medicine at the University of Washington, and lead author for the study. ?Our study shows that treatment with FINTEPLA not only reduces seizure activity, but also results in substantial benefits for many other aspects of the lives of those impacted by Dravet syndrome. The majority of caregivers reported that after treatment began, they felt less overwhelmed, less anxiety, and less stress. They noted improvements in sleep in both the child and themselves, and even noticed improvements in the siblings of the child with Dravet syndrome. As they witnessed these improvements, they experienced, for the first time in many years, hope for the future of their child.?
Study Methodology
Caregivers of patients who received FINTEPLA through either the Phase 3 clinical trial program or the U.S. early access program were recruited to participate in one-on-one semi-structured interviews to discuss the benefits of fenfluramine for the child with Dravet syndrome, as well as the parents and the family as a whole. A total of 59 caregivers with a mean age of 48, 85% female, and 88% living with their partner or spouse participated in the interviews. Discussions were audiotaped and used to generate summaries which were analyzed to identify themes for responses. The numbers and rates of responses in each category were then computed (for example, responses about topics such as shorter post-seizure recovery time). Caregivers also provided demographic and clinical information about their child with Dravet syndrome and completed a self-report survey about their own health and quality of life.
Study Results
Of the participants interviewed, 34% were caregivers of adult patients with Dravet syndrome. Mean age of patients with Dravet syndrome was 15 years (range, 2-33 years) and they had been on the FINTEPLA treatment regimen for an average of 21 months (range, 5-59 months).
- The most commonly reported non-seizure-related improvements were in the areas of cognition (76%), alertness (68%), education (65%), problem solving (56%), speech (48%), sleep quality (47%), motor function (46%), and mood (41%).
- Caregiver parents themselves reported feeling less overwhelmed (71%), less stress (66%), and less anxiety and depression (68%). More than two-thirds reported that the quality of their sleep improved (71%) and they had more time to do things they enjoy (56%). In addition, 44% of parents reported that the relationship with their spouse or partner improved and 62% of employed parents missed less work.
- Reported family benefits included less family stress (76%), improved relationship between the Dravet syndrome child and their siblings (56%), improved behavior and/or mood of siblings (58%), and easier time for their family to do things with others (64%).
- There is an association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension.
- Echocardiogram assessments are required before, during, and after treatment with FINTEPLA.
- FINTEPLA is available only through a restricted program called the FINTEPLA REMS.