New molecular entity: Gabapentin enacarbil extended-release tablets was approved by FDA as treatment for moderate-to-severe restless legs syndrome in adults.
Restless legs syndrome (RLS) is a disruptive neurologic disorder that affects up to 10% of Americans. RLS results in an irresistible urge to move the legs. On April 6, 2011, FDA approved gabapentin enacarbil extended-release tablets for the treatment of moderate-to-severe RLS in adults. Gabapentin enacarbil is not recommended for patients required to sleep during the daytime and remain awake at night.
Efficacy. Gabapentin enacarbil efficacy was established in two 12-week clinical studies in adults diagnosed with RLS using the International Restless Legs Syndrome (IRLS) Study Group Diagnostic Criteria (diagnostic criteria include, urge to move the legs usually accompanied by uncomfortable and unpleasant leg sensations during periods of rest or inactivity, symptoms are partially or totally relieved by movement and are worse or occur only in the evening or night). Patients with RLS secondary to other conditions (eg, pregnancy, renal failure, iron deficiency anemia) were excluded. In study 1, patients received 1,200 mg of gabapentin enacarbil (n=112) or placebo (n=108) taken once daily with food. In study 2, patients received 600 mg (n=112) and 1,200 mg (n=111) of gabapentin enacarbil or placebo (n=108) taken once daily with food. Efficacy was evaluated using the IRLS Rating Scale (including 10 items designed to assess the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence/sedation, and impact on activities of daily living and mood associated with RLS) and Clinical Global Impression of Improvement (CGI-I) scale. In both studies, statistically significant improvements between the gabapentin enacarbil 600 mg and placebo groups were observed at week 12 for both the IRLS Scale total score (-13.2 vs -8.8 and -13.0 vs -9.8, for study 1 and 2, respectively) and the proportion of responders as determined by the CGI-I scale (76% vs 39% and 73% vs 45%, for study 1 and 2, respectively).
Safety. In clinical trials, the most common adverse reactions (≥10% and at least 2 times the rate of placebo) seen with gabapentin enacarbil were somnolence/sedation and dizziness. The incidence of these adverse reactions was greater in these patients receiving 1,200 mg per day. Gabapentin enacarbil may cause significant driving impairment. As with other antiepileptic medications, gabapentin enacarbil may increase the risk of suicidal thoughts or behavior.
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.