New molecular entity: Ezogabine was FDA approved for use as an add-on medication to treat partial-onset seizures associated with epilepsy in adults.
Epilepsy is often difficult to manage, with one-third of patients failing to achieve satisfactory seizure control. Consequently, multiple antiepileptic drugs are frequently used in combination in an attempt to reduce seizure frequency. On June 10, 2011, FDA approved the oral potassium channel opener ezogabine for use as an add-on medication to treat partial-onset seizures associated with epilepsy in adults.
Efficacy. The efficacy of ezogabine as adjunctive therapy in partial-onset seizures was established in 3 multicenter, randomized, double-blind, placebo-controlled studies (n=1,239) that monitored seizure frequency. All 3 clinical studies enrolled patients suffering from partial-onset seizures, were taking at least 1 antiepileptic drug, and were inadequately controlled. In each trial, patients were randomly assigned to 600, 900, or 1,200 mg per day maintenance doses of ezogabine or placebo. In each of the 3 studies, the median percent reduction in 28-day seizure frequencies in patients receiving ezogabine 600, 900, and 1,200 mg per day were statistically greater than placebo.
Safety. In clinical trials, the most common adverse events (occurring >4% and approximately twice the placebo rate) were dizziness, somnolence, fatigue, confusional state, vertigo, tremors, abnormal coordination, diplopia, disturbance in attention, memory impairment, asthenia, blurred vision, gait disturbance, aphasia, dysarthria, and balance disorder. In most cases the reactions were of mild or moderate intensity. Other adverse reactions (occurring in <2% of patients) were increased appetite, hallucinations, myoclonus, peripheral edema, hypokinesia, dry mouth, dysphagia, hyperhydrosis, urinary retention (typically in the first 6 months of treatment), malaise, and increased liver enzymes. Adverse reactions were found to be directly correlated to dose. Like other antiepileptic drugs, ezogabine may cause suicidal thoughts or actions in a small number of people.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.