Dravet Syndrome: Therapy Targeting Underlying Cause Gets Orphan Drug Status
The Food and Drug Administration has granted Orphan Drug designation to STK-001 (Stoke Therapeutics) for the treatment of Dravet syndrome.
Dravet Syndrome
NDA for Low-Dose Fenfluramine Submitted for Treatment of Dravet Syndrome
Zogenix announced the submission of a New Drug Application to the FDA for Fintepla oral solution for the treatment of seizures associated with Dravet syndrome.
Diacomit Approved for the Treatment of Dravet Sydrome
Diacomit was evaluated in 2 multicenter, placebo-controlled, double-blind, randomized studies.
Cannabidiol Safe, Well Tolerated in Children With Dravet Syndrome
Because of the small size of the study sample, the findings may be limited to this patient population and may be hard to generalize across all pediatric patients with Dravet syndrome.
Cannabidiol Under Priority Review for Treatment of Lennox-Gastaut, Dravet Syndromes
The FDA has accepted for filing with Priority Review the NDA for cannabidiol as seizure treatment.
Reducing Seizure Frequency in Dravet Syndrome With Low-Dose Fenfluramine
ZX008 has received Orphan Drug designation and Fast Track designation by the FDA for the treatment of Dravet syndrome.
Add-on Cannabidiol Generally Safe for Treatment-Resistant Epilepsy, Dravet, Lennox-Gastaut Syndromes
Adverse reactions in the CBD group included decreased appetite, diarrhea, fatigue, lethargy, nasopharyngitis, pneumonia, pyrexia, rash, and somnolence.
Distinct Phenotype in Dravet Syndrome Helps Outline Treatment
In people with Dravet syndrome, language impairments increase with age, suggesting that early intervention with targeted oral motor therapies may be helpful.
VIDEO — Industry Update: Justin Gover, CEO, GW Pharmaceuticals on Epidiolex Status
Justin Gover, CEO of GW Pharmaceuticals, the parent company of Greenwich Biosciences, discusses the status of the company’s cannabidiol product Epidiolex on the heels of positive results from several placebo-controlled trials in epileptic syndromes.
Cannabidiol Reduces Seizure Frequency in Refractory Dravet Syndrome
Results of the phase 3, placebo-controlled trial support previous findings from an expanded-access program.
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