Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

Diacomit Approved for Treatment of Dravet Syndrome Seizures

By The U.S Food & Drug Administration | August 21, 2018

The FDA approved Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome, a rare form of epilepsy. 

Diacomit is indicated for use in patients two years of age and older taking clobazam. There are no clinical data to support the use of Diacomit as monotherapy in Dravet syndrome. 

Dravet syndrome is a rare genetic condition that usually appears during the first year of life with prolonged fever-related seizures (febrile seizures). Later, other types of seizures typically appear, including myoclonic seizures (involuntary, irregularly repetitive muscle jerks).

Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity, and difficulty relating to others.

The most common side effects reported with Diacomit are somnolence (sleepiness and drowsiness), decreased appetite, agitation, ataxia (impaired coordination and balance), weight loss, hypotonia (low muscle tone), nausea, tremor, dysarthria (difficulty speaking words; difficulty forming words during speech), and insomnia. 

Diacomit must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for many other drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression, and panic attacks.

(Source: The U.S. Food & Drug Administration)


Filed Under: Orphan Drugs

 

Related Articles Read More >

Bristol Myers Squibb
FDA approves Bristol-Myers Squibb immunotherapy for gastric cancer
eye
Investigational drug gives sight to patient with inherited form of blindness 
RedHill
Why RedHill Biopharma is expanding its focus on infectious disease
OncoSec eyes next steps with its cancer immunotherapy candidate

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Medtech100 Index
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50