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.

medscapesource:

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