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epilepsy

NHS guidelines on prescription cannabis to be challenged in court

Photo by Cannabis Tours

The cannabis guidelines followed by the NHS are set to be challenged in court by the parents of a three-year-old boy with severe epilepsy.

Matt and Ali Hughes treat their son Charlie with cannabis oil, which they buy privately, and it has reduced their son’s seizures from 120 a day to fewer than 20. Previously, the couple had given Charlie six different types of anti-epileptic drugs but they saw no improvement in his condition.

EMA gives market authorisation application to epilepsy treatment from Arvelle Therapeutics

The European Medicines Agency (EMA) has accepted a marketing authorisation application (MAA) for a cenobamate adjunctive treatment of focal-onset seizures in adults with epilepsy.

This approval was based on data from two randomised placebo controlled studies. It also included a large international open-label safety study.

Idorsia reveals it is working with Neurocrine on new epilepsy drug deal

Idorsia revealed its 2019 deal for its investigational epilepsy medicine was with Neurocrine Biosciences, and it is potentially worth more than $400 million.

The agreement calls for Idorsia to get $365 million in development, $45 million in cash and $7 million in research. It will also get regulatory milestone payments if Neurocrine exercises its option within 30 days of the FDA accepting an investigational new drug application, which is expected for mid-2020. There would also be royalties for its epilepsy drug, known as ACT-709478.

NHS to fast track cannabis-based treatment for epilepsy

The NHS has fast-tracked the drug Epidyolex, a cannabidiol (CBD), to be available for epilepsy treatment through the NHS in England, starting on 6 January 2020.

The drug had been recommend for use in treating two types of epilepsy, Lennox-Gastaut and Dravet syndromes, back in November.

Doctors will be able to prescribe the drug Epidyolex with clobazam for eligible children with this disease. Clinical trials have shown this treatment could reduce seizures of up to 40% in some children.

China approves Eisai's Fycompa for partial onset epileptic seizures

Tokyo-headquartered firm Eisai has announced that its antiepileptic drug (AED) Fycompa (perampanel) has received approval from China’s National Medical Products Administration (NMPA) for the adjunctive treatment of partial onset epileptic seizures(with or without secondarily generalised seizures) in patients over the age of 12.

The decision, awarded under the Administration’s Priority Review pathway in just over 12 months, was based on data from a number of Phase 3 studies which indicated that Fycompa reduced seizure frequency by 17.3%, 29% and 38.9% in its 4, 8 and 12mg formulatio

GW Pharma's cannabis-based Epidyolex edges closer to EU approval with positive CHMP opinion in epilepsy

UK-based biotech GW Pharmaceuticals has announced that its cannabidiol oral solution Epidyolex has secured recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The specialist panel chose to endorse the therapy and push for its approval, in combination with clobazam, as an adjunctive treatment for seizures associated with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome in patients at least two years old.

Pfizer's Lyrica fails at Phase 3 in treating primary generalised tonic-clonic (PGTC) seizures

Pfizer has unveiled new Phase 3 data on the effectiveness of Lyrica (pregabalin) in the adjunctive treatment of primary generalised tonic-clonic (PGTC) seizures in patients between the ages of five and 65 years old, revealing that the therapy failed to meet its primary endpoint.

Specifically, Pfizer announced that use of the drug did not lead to a statistically significant reduction in seizure frequency compared to placebo in testing of 219 participants. However, the manufacturer did note that the drug’s safety profile was consistent with previous findings.

GW Pharma's Epidiolex scores in rare childhood onset epilepsy Phase 3 trial

GW Pharma’s Epidiolex has shown positive Phase 3 trial results for the fifth time in a row, after meeting primary endpoints in a randomised, double blind, clinical study of patients with Tuberous Sclerosis Complex (TSC), a rare form of childhood onset epilepsy.

The CBD-based drug reduced seizures by 48.6% and 47.5% from baseline at doses of 25 and 50 mg/kg/day in patients with TSC, compared to a rate of 26.5% for placebo.

Epilepsy Society calls for review of UK supply chain following "steep rise" in access issues

The Epilepsy Society has drawn attention to the “steep rise” in UK patients who are encountering difficulty in accessing seizure medication.

While issues around access to these medicines have been or could be further exacerbated by Brexit, the society asserts that this has been a problem for over a decade, and one which Big Pharma has continuously failed to address.

The society has said that its “Helpline and enquiries desk inundated with worried callers”, and the added anxiety and stress is compounding the risk of seizures in patients.

Antiepileptics increase the risk of pneumonia in people with Alzheimer’s disease

Image Credit: GerryShaw

Antiepileptic drugs increase the risk of pneumonia in people living with Alzheimer’s disease, according to research from the University of Eastern Finland.

People with Alzheimer’s who used antiepileptics have twice the risk of developing pneumonia compared to those not using the drugs, the study, published in the Journal of Alzheimer’s Disease says.

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