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Medicine

FDA Expands Use of Epilepsy Drug Perampanel (Fycompa) to Younger Children

The US Food and Drug Administration (FDA) has granted expanded approval of perampanel (Fycompa, Esai Inc) for the treatment of “partial-onset seizures (POS) with or without secondary generalized seizures” in patients as young as 4 years, the manufacturer reports. The expanded indication is for both monotherapy and adjunctive use in patients 4 years of age and older. The drug was initially approved in 2012 as adjunctive treatment for POS. This was followed in 2015 by approval as adjunctive treatment for primary generalized tonic-clonic seizures in patients with epilepsy who were at least 12 years of age, and in 2017 as monotherapy for POS with or without secondary generalized seizures in the same age group. To date, the drug “is approved in 55 countries and has treated mor...

Epilepsy drug (Gabapentin/Neuronton) linked to opioid misuse

A recent study conducted by Duquesne University professor John Tomko has linked high dosages of the epilepsy drug Gabapentin to opioid abuse. Based on the findings of the study, Tomko recommends prescribing and distributing Gabapentin with more scrutiny and oversight. Gabapentin, brand name Neurontin, has been formally approved by the Food and Drug Administration (FDA) to treat symptoms of epilepsy, such as seizures and post herpetic neuralgia, a type of pain caused by shingles. According to Tomko, however, Gabapentin has been used off-label (i.e., not approved by the FDA) to treat other ailments such as back pain, anxiety, bipolar disorder, migraines and more. Tomko’s study found that subjects in UPMC Mercy’s Behavioral Health units were twice as likely to test positive for illicit drug a...

Newer epilepsy drugs fail to improve outcomes

Overall treatment outcomes in patients with epilepsy have failed to improve, despite the proliferation of several newer antiepileptic drugs (AEDs) with different mechanisms, according to a recent study published in JAMA Neurology. Treatment outcomes in patients with epilepsy have not improved, despite the advent of more than 15 newer antiepileptic drugs.   “Despite the availability of over 15 new drugs, overall seizure control in newly diagnosed patients has not fundamentally changed,” said senior author, Patrick Kwan, MD, PhD, Department of Medicine, The University of Melbourne, Parkville, Australia. “Newer AEDs are generally effective, and many have favorable safety profiles, but all have been reported to have efficacy similar to the established AEDs when used as monotherapy or adju...

FDA Approves Stiripentol for Dravet Syndrome Seizures

The US Food and Drug Administration today approved stiripentol (Diacomit) for the treatment of seizures associated with Dravet syndrome epilepsy. This is just the second approved form of treatment specifically for patients with Dravet syndrome. The drug is approved for use in patients 2 years of age and older who are taking clobazam. Stiripentol is not supported by clinical data for use as a monotherapy option for Dravet syndrome. Stiripentol is available in capsules to be taken orally, or in powder form for oral suspension. The daily dosage is 50mg/kg/day taken in 2 or 3 divided doses (16.67 mg/kg three times daily or 25 mg/kg twice daily). Capsules should be swallowed whole with water during a meal. The powder form should be mixed in water and taken immediately after a meal. Data from tw...

Early Treatment Failure More Likely With Carbamazepine vs Lamotrigine in Epilepsy

In patients with epilepsy, moderate-quality evidence indicates that treatment failure for any reason related to therapy or adverse events (AEs) occurs significantly earlier with carbamazepine than with lamotrigine, although the results for time to first seizure imply that carbamazepine may be superior to lamotrigine for seizure control. Results of the review were published in the Cochrane Database of Systematic Reviews. The current analysis was an individual participant data review. The primary outcome was time to treatment failure, and secondary outcomes included time to first seizure postrandomization; time to 6-month, 12-month, and 24-month remission; and incidence of AEs. Among the 14 trials included in this review, individual participant data were available for 2572 of 3787 eligible p...

FDA To Consider Midazolam Nasal Spray for Acute Cluster Seizure Treatment

The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for an investigational nasal spray therapy intended for the acute treatment of seizure clusters. Midazolam Nasal Spray—from global biopharmaceutical company UCB, Brussels, Belgium (UCB)—has been previously granted Orphan Drug and Fast Track designations by the FDA. It’s now set for a potential market approval in early 2019. The spray’s application is supported by data from the phase 3 Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray (ARTEMIS 1) trial, in which a 5mg intranasal dose of the therapy was tested for efficacy and safety in 292 patients with seizure clusters in a randomized, double-blind, placebo-controlled setting. Investigators had tested for a primary endpoint of seizure termi...

UCB Announces BRIVIACT® (Brivaracetam) now Approved by FDA to Treat Partial-onset (Focal) Seizures in Pediatric Epilepsy Patients

BRIVIACT® (brivaracetam) CV oral formulations are approved as a monotherapy or adjunctive therapy in patients four years of age and older with partial-onset seizures   – Approval provides pediatric epilepsy patients a treatment option which can be initiated at a therapeutic dose from day one   – Pediatric epilepsy is the most common, serious neurological disorder among children and young adults, thought to affect nearly 470,000 children in the U.S[1],[2]   – Indication comes less than 2 years after the launch of BRIVIACT in the U.S., building on existing adult monotherapy and adjunctive therapy indications, and broadening clinical application for UCB’s newest anti-epilepsy drug   UCB announced today that the U.S. Food and Drug Administration (FDA...

FDA Reports a Life-Threatening Immune Reaction to Lamotrigine: What You Should Know

A rare but life-threatening immune reaction in response to lamotrigine (Lamictal) requires prompt diagnosis and treatment, according to a recent alert from the U.S. Food and Drug Administration (FDA).   On April 25, the FDA issued what it calls a “drug safety communication” about the risk of a condition so rare that few neurologists have heard of it: hemophagocytic lymphohistiocytosis (HLH), a systematic immune reaction that can result in organ failure and death if not quickly treated.   Just eight such cases associated with lamotrigine, including one death, are known by the FDA to have occurred since the drug was first approved in 1994 as a treatment for epilepsy. Since then, it has also been approved for bipolar disorder, and is now increasingly prescribed off-label...

Antiepileptic drugs linked with an increased risk of Alzheimer’s and dementia, says research

According to a new study from the University of Eastern Finland and the German Center for Neurodegenerative Diseases, DZNE, antiepileptic drugs are associated with an increased risk of Alzheimer’s disease and dementia.   The clinical investigation, led by Heidi Taipale from the University of Eastern Finland, evaluated the data of nearly 100,000 individuals with dementia or Alzheimer’s disease (from Germany and Finland) to see if there was a link between continuous use of antiepileptics and these neurodegenerative diseases and compared it with controls.

Educational Attainment Down With In Utero Exposure to AEDs

Exposure to sodium valproate or a combination of antiepileptic drugs (AEDs) in utero is associated with worse attainment on national educational tests for 7-year-olds, according to a study published online March 26 in the Journal of Neurology, Neurosurgery & Psychiatry. Arron S. Lacey, from Swansea University Medical School in the United Kingdom, and colleagues identified children born to mothers with epilepsy and linked these children to their national attainment Key Stage 1 (KS1) tests in mathematics, language, and science at age 7. The children were compared with matched children born to mothers without epilepsy.

Medication Adherence Key to Epilepsy Treatment

In assessing the effectiveness of prescribed medication there is a strong emphasis on the ability of the patient to adhere to the regime recommended by the clinician. For individuals with epilepsy, adherence to medication is crucial in preventing or minimizing seizures and their cumulative impact on everyday life. Non-adherence to antiepileptic drugs (AEDs) can result in breakthrough seizures many months or years after a previous episode and can have serious repercussions on an individual’s perceived quality of life. Reasons for non-adherence are complex and multilayered. Patients can accidentally fail to adhere through forgetfulness, misunderstanding, or uncertainty about clinician’s recommendations, or intentionally due to their own expectations of treatment, side-effects, and lifestyle ...

Which commonly prescribed drug is more effective for infants with epilepsy?

Study to help clinicians select an initial treatment for infants with epilepsy:   Comparison of two of the most commonly prescribed drugs for infants with nonsyndromic epilepsy revealed that levetiracetam was more effective than phenobarbital, according a multicenter, observational study published in JAMA Pediatrics. After six months of single-drug treatment, 40 percent of infants who received levetiracetam met criteria for successful outcome – they did not require a second anti-epileptic drug to control their seizures and they became seizure-free within three months of starting treatment. Only 16 percent of infants treated with phenobarbital achieved the same outcome.   “This is the first study to provide evidence that may help clinicians select an initial treatment ...