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Topiramate

Generic Name
Topiramate
Brand Names
Eprontia, Qsymia, Qudexy, Topamax, Trokendi
Drug Type
Small Molecule
Chemical Formula
C12H21NO8S
CAS Number
97240-79-4
Unique Ingredient Identifier
0H73WJJ391
Background

Topiramate is a anti-epileptic drug used to manage seizures and prevent migraines. It was initially approved by the FDA in 1996. In 2004, topiramate was approved for the prevention of migraine in adults. Since 2012, the extended-release formulation has been approved in combination with phentermine for chronic weight management therapy in adults.

Characteristics that distinguish topiramate from other antiepileptic drugs are a monosaccharide chemical structure containing a sulfamate, and 40% of its mass accounted for by oxygen. Interestingly, topiramate was discovered by chance when attempts were made to formulate a novel antidiabetic drug.

Indication

Topiramate is indicated for the following conditions: 1)Monotherapy for partial onset or primary generalized tonic-clonic seizures for patients 2 years of age and above 2)Adjunctive therapy for partial onset seizures or primary generalized tonic-clonic seizures for both adult and pediatric patients above 2 years old 3)Adjunctive therapy for seizures associated with Lennox-Gastaut syndrome in patients above 2 years of age 4)Prophylaxis of migraine in children 12 years of age and older and adults.

Topiramate is also used off-label as an adjunct therapy for weight management and for mood disorders.

Associated Conditions
Alcohol Dependency, Epilepsy, Primary Generalized Tonic-Clonic Seizures, Generalized Tonic-Clonic Seizures, Lennox-Gastaut Syndrome, Migraine, Moods Disorders, Partial-Onset Seizures, Seizures, Weight
Associated Therapies
Chronic Weight Management therapy, Weight Reduction

VIVUS Launches QSYMIA in UAE, Marking First Middle East Market for Obesity Treatment

• VIVUS LLC has launched QSYMIA (phentermine and topiramate extended-release) in the United Arab Emirates for treating obesity in adults and children aged 12 and older, marking the first Middle Eastern country to approve the medication. • The World Obesity Federation projects that by 2035, approximately 7.5 million UAE residents will be overweight or living with obesity, with current obesity-related costs reaching nearly $12 billion annually. • VIVUS aims to expand QSYMIA's global reach to over one billion individuals by the end of 2025, with the medication already approved in several European countries under the brand name QSIVA.

Novo Nordisk Launches Home Delivery Service for Wegovy at $499 Monthly for Cash-Paying Patients

• Novo Nordisk introduces NovoCare Pharmacy, a direct-to-patient delivery service offering all Wegovy dose strengths at $499 per month for cash-paying and eligible commercially insured patients without coverage. • The launch comes as Wegovy supply stabilizes, with FDA confirming Novo Nordisk can now meet market demand following previous shortages that limited new prescriptions since 2022. • Currently, over 55 million Americans have coverage for weight management medicines, with 90% of insured Wegovy patients paying $0-$25 monthly for their prescriptions.

FDA Removes Ozempic and Wegovy from Shortage List, Sparking Legal Challenge from Compounding Groups

• The FDA has officially removed Novo Nordisk's semaglutide products, Ozempic and Wegovy, from its drug shortage list after being listed since 2022, signaling improved supply availability. • Compounding groups have filed a lawsuit challenging the FDA's decision, arguing it was made without proper stakeholder consultation and despite ongoing supply challenges acknowledged by Novo Nordisk. • The legal dispute highlights broader tensions between pharmaceutical manufacturers and compounding facilities over access to semaglutide for treating type 2 diabetes, obesity, and cardiovascular disease.

WEGOVY's Market Dominance Grows with Expanded Cardiovascular Indication and Strong Clinical Results

• Novo Nordisk's WEGOVY has secured FDA approval for cardiovascular risk reduction in March 2024, becoming the first obesity medication authorized to reduce cardiovascular death, heart attack, and stroke risks. • Phase IIIb STEP UP trial demonstrates superior efficacy of WEGOVY 7.2mg compared to 2.4mg dosage, showing significant weight loss benefits at 72 weeks in adults with obesity. • WEGOVY generated impressive US sales of $6.4 billion in 2024, with market presence now extending to over 15 global markets including recent approval in Japan.

Medicare to Negotiate Single Price for Novo's Semaglutide Products Including Ozempic and Wegovy

• Medicare has selected semaglutide as one of 15 drugs for its second round of price negotiations, treating all formulations including Ozempic, Wegovy, and Rybelsus as a single product. • The negotiations will establish a unified "maximum fair price" for all semaglutide products, impacting Novo Nordisk's medications that currently list at $998-$1,349 per month. • CMS's approach focuses on the drug's active moiety rather than individual brand names, aiming to prevent "product hopping" and ensure consistent pricing across different formulations.

EMA Investigates Potential Link Between Semaglutide and Rare Eye Condition NAION

• The European Medicines Agency (EMA) is reviewing semaglutide, the active ingredient in Ozempic and Wegovy, following reports of a potential link to non-arteritic anterior ischemic optic neuropathy (NAION). • The review was prompted by two studies from the University of Southern Denmark suggesting a doubled risk of NAION in patients using semaglutide. • NAION is a rare eye condition involving reduced blood flow to the optic nerve, potentially leading to vision loss, and the EMA will assess all available data to determine if there is a causal relationship. • The investigation follows increasing concerns and reports of NAION in semaglutide users, with the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) evaluating the evidence.

Eton Pharmaceuticals Acquires U.S. Rights to Amglidia for Neonatal Diabetes

• Eton Pharmaceuticals has acquired U.S. rights to Amglidia (glyburide oral suspension) from AMMTeK for treating neonatal diabetes mellitus. • Amglidia, already EMA-approved and available in Europe, addresses the unmet need for an FDA-approved oral treatment for this rare condition. • Eton plans to meet with the FDA in early 2025 and anticipates submitting an NDA for Amglidia in 2026, leveraging existing European safety and efficacy data. • The acquisition aligns with Eton's focus on pediatric endocrinology and expands its portfolio of treatments for rare diseases.
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