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Weekly Drug News Round Up - June 13, 2012

Perjeta Adds Half-Year of Survival in HER2-Positive Metastatic Breast Cancer

Combination of Perjeta (pertuzumab), trastuzumab, and docetaxel leads to additional 6.1 months progression-free survival Read More...

The U.S. Food and Drug Administration has approved Perjeta (pertuzumab), a HER2/neu receptor antagonist indicated in combination with Herceptin (trastuzumab) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Comparative, Phase III trials with trastuzumab plus docetaxel or Perjeta, trastuzumab, and docetaxel in patients with previously untreated HER2-positive mBC extended progression-free survival (cancer not worsening) for a median of 6.1 months (12.4 months vs. 18.5 months). Perjeta is expected to be commercially available from Genentech by the third week of June 2012.

Horizant Receives New Indication For Postherpetic Neuralgia

Horizant (gabapentin enacarbil) now approved for both restless leg syndrome and postherpetic neuralgia Read More...

Postherpetic neuralgia (PHN) is a painful nerve syndrome that occurs in roughly 100,000 people per year who have had herpes zoster (shingles). The pain associated with PHN may lead to morbidity and disability in the affected patient. Horizant (gabapentin enacarbil) extended-release tablets are now approved as a treatment for PHN in adults. Maintenance dosing is 600 mg twice a day, and dizziness (17% of patients) and drowsiness (10% of patients) are the most frequently reported Horizant side effects. Horizant cannot be interchanged with other gabapentin products due to differing pharmacokinetic and plasma concentration profiles. Other drugs useful for PHN include pregabalin (Lyrica), immediate-release gabapentin (Neurontin), carbamazepine (Tegretol), and certain tricyclic antidepressants.

Delamanid Shows Promise For Multidrug-resistant Tuberculosis

Investigational agent has novel mechanism of action; shows potent action against drug-resistant strains of M. tuberculosis Read More...

Tuberculosis (TB) is a deadly infectious disease, claiming the lives of 1.5 million people worldwide each year. If initial treatment options such as rifampin and isoniazid fail, second-line drugs must be taken for up to two years, and treatment success is still not guaranteed. A multinational, Phase II study in 481 patients demonstrated that the investigational agent delamanid cleared the TB bacteria from sputum cultures in 42 to 45 percent of patients after eight weeks. Delamanid inhibits the production of mycolic acid, a building block of the TB bacteria. Side effects concerns exist over the potential for QT prolongation, an electrical cardiac abnormality seen during the trial.

Healthy Postmenopausal Women: Low Dose Calcium, Vitamin D Not Needed

U.S. task force says postmenopausal women should not take low doses of calcium, vitamin D to prevent fractures Read More...

Half of postmenopausal women will experience a bone fracture. Accordingly, women have been told for years to take calcium and vitamin D to help prevent possible debilitating fractures. However, this week the U.S. Preventive Services Task Force (USPSTF) released draft recommendations stating that postmenopausal women should not take low-dose supplements, defined as 400 IU of vitamin D with 1,000 milligrams calcium. The USPSTF states there is no evidence to support the use of low-dose supplements to prevent fractures in postmenopausal women, but use may slightly increase the risk for kidney stones. The effects of higher doses on risk fracture are not fully known at this time.

FDA: Controlling Childhood Asthma Is Key

Children with asthma can lead normal, active lives if asthma remains controlled with the right medications Read More...

Modern medicine has changed the lives of asthmatic children. They can be active in sports and lead healthy and productive childhoods. However, it is important to remember that asthma is a chronic condition and good control must be maintained. A U.S. Food and Drug Administration Consumer Update reminds parents and kids about asthma symptoms, triggers and medication control. Rescue medications such as albuterol, inhaled corticosteroids (ICSs) like budesonide, leukotriene modifiers, such as montelukast, and bronchodilator combinations are all effective options. To best control the asthma, treatment should be individualized for each patient based on disease severity, frequency of symptom flare-ups, the child's age, activity schedule and cost.