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Weekly Drug News Round Up - August 29, 2012

Afinitor Disperz Approved for Rare Pediatric Cancer

Afinitor Disperz is the first pediatric form of Afinitor Read More...

The anti-cancer agent Afinitor Disperz (everolimus tablets for oral suspension) has been approved for children aged one and older who have tuberous sclerosis complex (TSC) and an accompanying rare brain tumor, subependymal giant cell astrocytoma (SEGA), that cannot be treated with surgery. TSC is a rare genetic disease that often spurs tumors in the brain and other key organs. Afinitor Disperz is dissolved in a small amount of water prior to administration to ease dosing in children who are unable to swallow tablets. The most common side effects observed during clinical trials were mouth ulcers and respiratory infections.

Nucynta ER Approved for Diabetic Peripheral Neuropathy Pain

The most common side effects included nausea, constipation, vomiting, dizziness, headache and somnolence Read More...

Diabetic peripheral neuropathy, which may cause pain or loss of feeling in the toes, feet, legs, hands and arms affects roughly 8 million people in the U.S. Nucynta ER (tapentadol) has been approved by the U.S. Food and Drug Administration (FDA) for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults when a continuous, around-the-clock opioid analgesic is needed. Nucynta ER is an extended-release, oral tablet taken twice daily. Nucynta ER is also approved for the long-term, around-the-clock management of moderate to severe chronic pain not associated with DPN.

Tbo-filgrastim Approved for Severe Neutropenia

Tbo-filgrastim injection stimulates the bone marrow to increase the production of neutrophils Read More...

The U.S. Food and Drug Administration (FDA) has approved tbo-filgrastim to reduce the time certain patients receiving chemotherapy have severe neutropenia - a lowered level of white blood cells that fight off infection. Tbo-filgrastim is intended for patients being treated with chemotherapy that causes a substantial decrease in the production of the white blood cells in the bone marrow and who have non-myeloid malignancies, which means the cancer is not of blood or bone marrow origin. Effectiveness was determined based on trial results demonstrating that severe neutropenia lasted 1.1 days in patients receiving tbo-filgrastim compared with 3.8 days in those receiving the placebo.

Four-Drug Combo Approved for HIV Treatment

Common side effects include diarrhea, nausea; serious effects include kidney problems, decreased bone mineral density Read More...

The U.S. Food and Drug Administration has approved Gilead’s once-a-day Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) to treat HIV-1 infection in adults who have not previously received HIV treatment. Stribild contains two previously approved HIV drugs - emtricitabine and tenofovir plus two new drugs, elvitegravir and cobicistat. Elvitegravir is an HIV integrase strand transfer inhibitor that interferes with a required enzyme. Cobicistat, a pharmacokinetic enhancer, inhibits an enzyme that metabolizes certain HIV drugs; it is used to prolong the effect of elvitegravir. Two clinical studies found that roughly 90 percent of patients treated with Stribild had undetectable levels of HIV in their blood after 48 weeks of treatment. Stribild had previously been referred to as the “Quad”.

Atenolol or Metoprolol? No Difference Found in Prevention of Cardiac Events

Review of atenolol compared to metoprolol finds no difference in terms of preventing stroke, heart attack Read More...

Previous research indicated that atenolol might be less useful than other high blood pressure drugs for preventing heart events in patients with high blood pressure. However, a retrospective review published in the Archives of Internal Medicine reports no difference between atenolol and metoprolol in terms of preventing stroke, heart attack or heart failure for patients with high blood pressure. Researchers reviewed medical records of roughly 121,000 patients with high blood pressure but no other heart events and who started either metoprolol or atenolol between 2000 and 2009. During a five-year follow-up, no significant difference was noted in rates of heart attack, stroke or heart failure between the two groups of patients.