Pharmachronicles

Top Menu

  • Home
  • Our Blog
  • Contact Us

Main Menu

  • Home Page
  • STUDENTS ZONE
  • Syllabus
  • Seminars & conferences
  • Online classes
    • Register
Sign in / Join

Login

Welcome! Login in to your account
Lost your password?

Lost Password

Back to login
  • Home
  • Our Blog
  • Contact Us

logo

  • Home Page
  • STUDENTS ZONE
  • Syllabus
  • Seminars & conferences
  • Online classes
    • Register
  • Resurgence of COVID-19 in Hong Kong and Singapore: A New Wave Driven by Waning Immunity and Emerging Variants

  • How Pharmacists Support Chronic Disease Management in the Community

  • OTC Medications: Safe Use, Common Mistakes, and Pharmacist Guidance

  • Pharmacovigilance Explained: Why Reporting Adverse Drug Reactions Saves Lives

  • Indian CDMOs Gain Global Momentum Amid Pharma’s Shift from China

FDA Alerts
Home›FDA Alerts›FDA approved a new drug for seizures associated with Dravet Syndrome

FDA approved a new drug for seizures associated with Dravet Syndrome

By Ramoju kishore kumar
August 22, 2018
836
0
Share:

Recently FDA has approved DIACOMIT(stiripentol) for seizures associated with dravet syndrome in patients.

Dravet syndrome is a rare genetic condition that usually appears during the first year of life with prolonged fever-related seizures. Later, other types of seizures typically appear, and 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 efficacy of Diacomit was established in two multicenter placebo-controlled double-blind randomized studies (Study 1 and Study 2). Patients enrolled in the studies were required to be aged between 3 years and under 18 years with Dravet syndrome that was inadequately controlled with clobazam and valproate, and experiencing at least 4 generalized clonic or tonic-clonic seizures per month.

After a 1-month baseline period where patients continued to receive clobazam and valproate, they were then randomly selected to receive additional treatment with either Diacomit or placebo for a double-blind period of two months.

The primary efficacy endpoint for both studies was the responder rate – a responder being a patient who experienced more than 50% decrease in the frequency of seizures per month during the two month double-blind period compared to the one month baseline period.

In both studies, the responder rate was significantly greater for Diacomit than for placebo. In Study 1 (N=41), 71% of Diacomit patients (N=21) were responders, compared to 5% of patients taking the placebo (N=20), and 43% of patients reported no generalized clonic or tonic-clonic seizure during the duration of the study. In Study 2 (N=23), 67% of Diacomit patients (N=12) were responders, compared to 9.1% of patients taking the placebo (N=11), and 25% of patients reported no seizures.

The exact mechanism of action by which Diacomit exerts its anticonvulsant effect in humans is unknown, but possible actions include direct effects mediated through GABAA receptors and indirect effects involving inhibition of CYP450 activity.

Common side effects (occurring in at least 10% of Diacomit-treated patients) included somnolence (sleepiness and drowsiness), decreased appetite, agitation, ataxia (impaired coordination and balance), weight decreased, hypotonia (low muscle tone), nausea, tremor, dysarthria (difficulty speaking words; difficulty forming words during speech), and insomnia.

Diacomit will be available as oral capsules and powder for oral suspension, and prescriptions 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.

TagschildrenDravet syndromeSeizures
Previous Article

Understanding About ANGINA PECTORIS

Next Article

Stem cell therapy for congestive heart failure

0
Shares
  • 0
  • +
  • 0
  • 0
  • 0
  • 0
Avatar photo

Ramoju kishore kumar

Related articles More from author

  • Medical research

    Can Biological clock Affect Timing of Epileptic Seizures

    September 20, 2018
    By Ramoju kishore kumar
  • BLOGS

    An innovative idea (Jerry the Bear) helps kids to manage diabetes.

    October 3, 2017
    By admin
  • Educational news

    National ethical guidelines for biomedical research involving children

    October 14, 2017
    By admin
  • FDA AlertsMedical & HealthMedical research

    FDA approves a new clinical trial for non-healing wounds.

    October 28, 2017
    By admin
  • FDA Alerts

    FDA recalls a anti hypertensive drug due to cancer concerns

    July 19, 2018
    By Ramoju kishore kumar
  • FDA Alerts

    FDA Approves Humanized Monoclonal Antibody For Migraine Treatment.

    September 30, 2018
    By Pharmachronicles

Leave a reply Cancel reply

You may interested

  • BLOGS

    Record Numbers of FDA‑Approved Drugs: Recent Trends

  • Uncategorized

    Pharmaceutical Technology Study materials

  • Uncategorized

    Resume Writing Tips

  • LATEST REVIEWS

  • TOP REVIEWS

  • Pharmacists are not eligible for certificate program of community health

    0
  • A New Class of Antimicrobials Has Just Been Found in Human Breast Milk Fresh super ...

    0

Timeline

  • May 17, 2025

    Resurgence of COVID-19 in Hong Kong and Singapore: A New Wave Driven by Waning Immunity and Emerging Variants

  • May 9, 2025

    How Pharmacists Support Chronic Disease Management in the Community

  • May 9, 2025

    OTC Medications: Safe Use, Common Mistakes, and Pharmacist Guidance

  • May 7, 2025

    Pharmacovigilance Explained: Why Reporting Adverse Drug Reactions Saves Lives

  • May 6, 2025

    Indian CDMOs Gain Global Momentum Amid Pharma’s Shift from China

Latest Comments

  • Pharmachronicles
    on
    February 27, 2025
    Thank you sir

    Streamlining Salaries through Payment Credit System and Other Benefits for Pharmacy Professionals: Suggestive Measures for PCI ...

  • G Krishna moorthy
    on
    February 1, 2025
    Good 👍 efforts Congratulations Continue your valuable professional services

    Streamlining Salaries through Payment Credit System and Other Benefits for Pharmacy Professionals: Suggestive Measures for PCI ...

  • Aarati sonawane
    on
    January 31, 2025
    Use in toppical application

    Role of Artificial Intelligence in 3D Printing Personalized Medication

  • Sowmya V
    on
    December 13, 2019
    Nice keep it up

    Blood Test Might Predict Pregnancy Due Date and Preterm Birth

Find us on Facebook

Follow Us on Instagram

logo

Dui viverra Faucibus aliquet quis phasellus accumsan. Donec et facilisis sociosqu sed tortor elit eu aliquid turpis ridiculus.

Fly, shall, have greater fifth spirit midst under from stars thing is, had creepeth multiply kind. Man may they’re meat years have third bring replenish air two light deep fill.

About us

  • Dr.N.Sriram, Founder CEO, Pharmachronicles, HITS college of Pharmacy, Ghatkesar, Hyderabad, India
  • 9704361947
  • pharmachronicles@gmail.com
  • Recent

  • Popular

  • Comments

  • Resurgence of COVID-19 in Hong Kong and Singapore: A New Wave Driven by Waning Immunity ...

    By Pharmachronicles
    May 17, 2025
  • How Pharmacists Support Chronic Disease Management in the Community

    By Pharmachronicles
    May 9, 2025
  • OTC Medications: Safe Use, Common Mistakes, and Pharmacist Guidance

    By Pharmachronicles
    May 9, 2025
  • Pharmacovigilance Explained: Why Reporting Adverse Drug Reactions Saves Lives

    By Pharmachronicles
    May 7, 2025
  • pharmacy credit system

    Streamlining Salaries through Payment Credit System and Other Benefits for Pharmacy Professionals: Suggestive Measures for ...

    By Pharmachronicles
    February 1, 2025
  • Blood Test Might Predict Pregnancy Due Date and Preterm Birth

    By Sundari srinidhi
    December 12, 2019
  • Ai in 3D printing

    Role of Artificial Intelligence in 3D Printing Personalized Medication

    By Pharmachronicles
    January 29, 2025
  • FDA is carefully evaluating prescription opioid medications approved to treat cough in children

    By admin
    July 16, 2015
  • Pharmachronicles
    on
    February 27, 2025

    Streamlining Salaries through Payment Credit System and Other Benefits for Pharmacy Professionals: Suggestive Measures for PCI ...

    Thank you sir
  • G Krishna moorthy
    on
    February 1, 2025

    Streamlining Salaries through Payment Credit System and Other Benefits for Pharmacy Professionals: Suggestive Measures for PCI ...

    Good 👍 efforts Congratulations ...
  • Aarati sonawane
    on
    January 31, 2025

    Role of Artificial Intelligence in 3D Printing Personalized Medication

    Use in toppical application
  • Sowmya V
    on
    December 13, 2019

    Blood Test Might Predict Pregnancy Due Date and Preterm Birth

    Nice keep it up

Photostream

    Follow us

    • Contact
    • STUDENTS ZONE
    • About Us
    © Copyright Pharmachronicles. All rights reserved.