FDA Approves Ezogabine for Seizures in Adults

The US Food and Drug Administration (FDA) approved ezogabine (Potiga, Valeant Pharmaceuticals and GlaxoSmithKline [GSK]) as an add-on medication to treat seizures associated with epilepsy in adults.

Ezogabine was approved for the treatment of partial seizures and is the first in its class as an activator of voltage-gated potassium channels in the brain developed for the treatment of epilepsy. The exact mechanism of action is unknown, but ezogabine may act as an anticonvulsant by reducing excitability through the stabilization of neuronal potassium channels in an "open" position.

Adverse events associated with ezogabine in clinical trials included dizziness, fatigue, confusion, vertigo, tremor, problems with coordination, double vision, problems paying attention, memory impairment, and lack of strength.

Ezogabine may also cause urinary retention, or difficulty in complete emptying of the bladder, generally within the first 6 months of treatment. Urologic symptoms in patients should be carefully monitored in patients taking this medication, the FDA suggests.

Neuropsychiatric symptoms, including confusion, hallucinations, and psychotic symptoms, may also occur with the use of ezogabine but typically resolve within a week after discontinuation of the treatment. In rare instances, this agent may be associated with suicidal ideation.

Source:Medscape

Adjuvant Clonidine XR for ADHD Improves Outcomes in Poor Responders

Adjuvant Clonidine XR for ADHD Improves Outcomes in Poor Responders

FDA Approves Boceprevir for HCV

The US Food and Drug Administration (FDA) has approved boceprevir (Victrelis, Merck) for hepatitis C virus (HCV) infection, making it the first new drug for HCV in 20 years.
Boceprevir is approved for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in patients aged 18 years of age and older with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
Boceprevir interferes with the ability of the HCV to replicate by inhibiting a key viral enzyme (NS3/4A serine protease).
The most commonly reported adverse reactions (>35%) were fatigue, anemia, nausea, headache, and dysgeusia. The most common reason for dose reduction in the trials was anemia.
source:medscape

FDA Approves Abiraterone for Metastatic Prostate Cancer

The US Food and Drug Administration (FDA) has approved abiraterone acetate (Zytiga, Cougar Biotechnology) in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer in men who have received prior docetaxel chemotherapy.


The new drug targets the protein cytochrome P450 17A1 (CYP17A1), which plays an important role in the production of testosterone, according to the FDA. Abiraterone works by decreasing the production of testosterone, which stimulates prostate cancer cell growth.


In addition to the newly approved abiraterone, 2 other new agents have been approved for men with advanced prostate cancer in the past year.

Sipuleucel-T (Provenge, Dendreon) is an immunotherapy indicated for asymptomatic or minimally symptomatic men with castration-resistant metastatic prostate cancer. It improved overall survival duration by a median of 4.1 months compared with survival in a control group.

Candidates for this vaccine should have a good performance status, an estimated life expectancy of more than 6 months, and no visceral disease, according the 2011 National Comprehensive Cancer Network guidelines.

Another new second-line option in this setting — cabazitaxel (Jevtana, Sanofi-Aventis) — has also been shown in a phase 3 trial to prolong overall survival; median survival duration was 15.1 months in the cabazitaxel group and 12.7 months in the mitoxantrone group.

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Paliperidone Approved for Schizophrenia in Adolescents

 The US Food and Drug Administration (FDA) has approved paliperidone (Invega; Ortho-McNeil-Janssen Pharmaceuticals) for the treatment of schizophrenia in adolescent patients aged 12 to 17 years. Paliperidone is an atypical antipsychotic and was originally approved in 2006 for the treatment of schizophrenia in adults.


Paliperidone is a centrally active dopamine D(2)- and serotonergic 5-HT(2A)-receptor antagonist. The extended-release formulation allows once-a-day dosing. The controlled release rate provides gradual ascending plasma concentrations peaking at 24 hours after the first dose and minimal fluctuation thereafter. Steady-state levels are obtained after 4 daily doses.


source:medscape

FDA Approves Rituximab (Rituxan) for Rare Disorders

The U.S. Food and Drug Administration approved Rituxan, in combination with certain steroids, to treat patients with Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA).

Rituxan is already approved to treat rheumatoid arthritis, non-Hodgkin's lymphoma and chronic lymphocytic leukemia.

It is an antibody that works by binding itself to a specific protein found on the surface of malignant and normal B-cell lymphocytes, enlisting the body's own immune system to kill marked cells.

source:medscape

FDA Approves PED Device to Treat Brain Aneurysms

A new device for treating brain aneurysms that spares the need for open surgery has been approved by the US Food and Drug Administration (FDA).

According to Christy Foreman of the Office of Device Evaluation, Center for Devices and Radiological Health, the Pipelineembolization device (PED) "offers neurointerventional surgeons an alternative to open surgery or placement of materials such as coils or a liquid embolic when treating carotid artery brain aneurysms."

The PED, manufactured by ev3, is a flexible mesh tube made of nickel-cobalt chromium alloy and platinum. The device can block giant and wide-necked aneurysms in the carotid artery that supplies blood to the brain. Furthermore, the PED reduces the chance that the aneurysm will rupture.

The PED is contraindicated in patients with an active infection and patients unable to take antiplatelet therapy, such as aspirin. Patients should receive adequate antiplatelet therapy before implantation of the device. The PED should not be used to treat a previously stented aneurysm.

source:medscape