The Lancet publishes Phase 3 trial results of FINTEPLA® of Zogenix
Category: #health  By Saipriya Iyer  Date: 2019-12-18
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The Lancet publishes Phase 3 trial results of FINTEPLA® of Zogenix

Zogenix, a renowned US-based pharmaceutical company, reportedly announced that The Lancet, a renowned medical journal, has published the company's Phase 3 trial outcomes for FINTEPLA® drug which would be used to treat Dravet Syndrome.

The trial was conducted in young adults and children suffering from Dravet syndrome. Dravet syndrome is a severe and rare infantile-onset epilepsy. The syndrome is characterized by disabling and frequent seizures that are highly difficult to treat with the current anti-epileptic drugs.

Co-lead author of the manuscript, Principal Investigator for Trial 1, Director at the Pediatric Epilepsy Center of Excellence of the UCSF Benioff Children’s Hospitals, Joseph Sullivan, M.D. stated that the results from this trial are highly encouraging in decreasing the duration and magnitude of seizures in patients suffering from Dravet syndrome.

Sullivan further added that if future results are also positive, it could allow clinicians to set a new standard of care for a therapy-resistant disease like Dravet syndrome. A disease where significant functional and cognitive impairments, frequent debilitating seizures are commonplace.

The most general adverse events found in at least 10 percent of patients, and with more frequency in the FINTEPLA groups, were diarrhea, decreased appetite, lethargy, fatigue, decreased weight and somnolence. Echocardiographic examinations showed normal valve functioning and morphology in every patient during the study. There were no indications of pulmonary arterial hypertension.

Stephen J. Farr, Ph.D., Chief Executive Officer and President at Zogenix stated that the company is proud that a renowned, prestigious journal, The Lancet, has published the phase 3 results for the global medical community. The company very much appreciates the patients, investigators, and families who made this trial possible.

Farr further added that in addition, the company is thrilled to observe the continued signs of efficacy and safety of its investigational drug, FINTEPLA. This drug is used for Dravet syndrome over time in the company’s ongoing open-label extension trial. The company looks forward to continuing to operate with regulators to enhance FINTEPLA as a novel treatment option for patients diagnosed with Dravet syndrome.

 

Source credit: https://zogenixinc.gcs-web.com/news-releases/news-release-details/lancet-publishes-phase-3-trial-results-zogenix-investigational



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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