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Weekly Drug News Round Up - June 27, 2012

Belviq (Lorcaserin) Approved For Obesity Treatment

First new weight loss drug in over a decade is FDA-approved; drug works on the serotonin system Read More...

In a long awaited decision, the FDA has approved the weight-loss drug Belviq (lorcaserin). Anticipation has been high for lorcaserin approval as this is the first new weight-loss drug available in over 13 years, and obesity concerns in the US are at an all-time high. Belviq is a serotonin receptor agonist, activating the 2C receptors in the brain to help a person eat less and feel fuller even after small meals. Belviq is indicated as an adjunct to diet and exercise for weight loss in obese, or overweight patients who have at least one weight-related risk factor, such as high blood pressure, type 2 diabetes, or high cholesterol. In clinical trials patients lost an average of 3 to 3.7 percent of their weight.

FDA: Adjust Cefepime Dose In Kidney Impairment To Help Avoid Seizures

Cefepime leads to nonconvulsive status epilepticus in patients with kidney impairment; in most cases seizures were reversible Read More...

Cefepime (Maxipime) is a 4th generation cephalosporin indicated for treatment of bacterial infections. The U.S Food and Drug Administration is informing healthcare providers that nonconvulsive status epilepticus has primarily been reported in patients with kidney impairment receiving unadjusted doses of cefepime, but has also been reported in patients without kidney impairment. Cefepime doses or intervals should be adjusted in patients with creatinine clearance less than or equal to 60 mL/min. Symptoms of nonconvulsive status epilepticus could include confusion and decreased responsiveness. If seizures associated with cefepime therapy occur, consider discontinuing cefepime or adjusting the dose in renal impairment. The cefepime label is being revised to highlight this risk.

Lyrica Approved For Neuropathic Pain Associated With Spinal Cord Injury

Lyrica reviewed under priority designation; first FDA-approved treatment for spinal cord injury-associated neuropathic pain Read More...

The U.S. Food and Drug Administration (FDA) has approved Lyrica (pregabalin) for neuropathic pain associated with spinal cord injury. There are over 270,000 patients with spinal cord injuries in the U.S., and 40 percent are afflicted with debilitating neuropathic pain. Chronic pain can hinder rehabilitation and functioning in the these patients, and until now no approved treatment option was available. FDA-approval was based on two phase 3, placebo-controlled clinical trials in which patients received 150-600 mg per day of Lyrica in conjunction with other pain treatments, such as NSAIDs or opioids. Results were statistically significant, reducing pain as early as one week in some patients and continuing throughout the 12 or 16 week studies.

Girls At Higher Risk For Sliding Math Scores If ADHD Treatment Delayed: Study

Girls more likely to exhibit inattention in ADHD and may be at greater risk of falling math scores without treatment Read More

A 5-year study in the journal Pediatrics has shown that delaying ADHD treatment can affect scholastic scores. The study looked at over 1,000 children with attention deficit/hyperactivity disorder (ADHD). Girls who started treatment late, defined as any treatment that began 25 to 36 months after a fourth-grade standardized test, had a 2.7 times higher risk of declining math scores compared to boys, who saw a 40 percent increased risk of declining math scores when tested again at 7th grade. Overall, 70 percent had an increased risk of lower math scores with late treatment. Over 95 percent of children received methylphenidate (Ritalin) treatment in this study.

Gammagard Approved For Treatment of Multifocal Motor Neuropathy


First U.S. immunoglobulin approval for multifocal motor neuropathy

The U.S. Food and Drug Administration has approved Gammagard 10% as an orphan drug treatment for Multifocal Motor Neuropathy (MMN). Patients afflicted with MMN exhibit progressive limb weakness which can lead to difficulty in performing simple tasks. Approval was based on a placebo-controlled, crossover trial in 44 patients measuring grip strength and disability. The difference in the relative change in mean grip strength was significant at 22.94 percent. A greater proportion of patients who received placebo experienced deterioration compared to Gammagard recipients (35.7% vs. 11.9%). Most patients (69%) in the placebo period were switched over early to Gammagard due to disease deterioration.