Monthly News Round Up - June 2012

Belviq (lorcaserin) Approved For Obesity Treatment

In a long awaited decision, the FDA has approved the weight-loss drug Belviq (lorcaserin). Anticipation has been high for lorcaserin approval as it is the first weight-loss drug available in over 13 years, and obesity concerns are at an all-time high in the US. 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.

First-In-Class Myrbetriq Approved for Overactive Bladder

The use of overactive bladder (OAB) medications are problematic for patients who are sensitive to certain side effects like dry mouth, constipation, and blurred vision. Myrbetriq (mirabegron) is a new beta-3 adrenergic agonist indicated for the treatment of OAB with symptoms of urge incontinence, urgency, and urinary frequency. Mirabegron works by a new mechanism to stimulate the beta-3 receptors, causing relaxation of the bladder muscle and improved bladder storage capacity. Myrbetriq side effects may include hypertension and the risk for urinary retention in patients receiving adjunct antimuscarinic agents for OAB or with bladder outlet obstruction. Myrbetriq, a CYP2D6 inhibitor, must be used cautiously with CYP2D6 substrates such as thioridazine, flecainide and propafenone to avoid serious drug interactions.

MenHibrix Approved: Combo Meningitis Vaccine for Infants, Toddlers

Meningitis is a life-threatening disease caused by the inflammation of the protective membranes covering the brain and spinal cord. The U.S. Food and Drug Administration (FDA) has approved the MenHibrix vaccine that targets two potential sources of meningitis, the Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b bacteria. Meningococcal disease occurs most frequently in infants and toddlers less than 2 years of age, while Hib disease was previously the leading cause of bacterial meningitis in children less than 5 years old prior to widespread vaccination. MenHibrix clinical trials occurred in over 7,500 infants and toddlers. Side effects included injection site pain and redness, irritability, drowsiness and loss of appetite.

Lyrica Approved For Neuropathic Pain Associated With Spinal Cord Injury

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.

Gammagard Approved For Treatment of 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 23 percent. A greater proportion of patients who received placebo experienced deterioration compared to Gammagard recipients (36% vs. 12%). Most patients (69%) in the placebo period were switched over early to Gammagard due to disease deterioration.

Posted: June 2012


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