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Weekly Drug News Round Up - October 7, 2015

Aristada: New Extended-Release Schizophrenia Drug Approved

The injection is given every four to six weeks Read More...

Schizophrenia is a chronic, severe and disabling mental health disorder often first seen in adults younger than 30 years of age. Symptoms may include hearing voices, being suspicious and withdrawn, and thoughts that someone is controlling their mind. Aripiprazole is an antipsychotic medication to help control these symptoms. The US Food and Drug Administration has approved Aristada (aripiprazole lauroxil), a long-acting injectable atypical antipsychotic. In clinical trials, the most common side effect was feeling the urge to move constantly (akathisia). Aripiprazole (Abilify) is also available in an oral formulation that is given daily and in another extended-release product known as Abilify Maintena. Generic oral formulations are also available.

New Indication: Keytruda For Advanced Non-Small Cell Lung Cancer

Lung cancer is the top cause of cancer death in the US with 158,040 deaths in 2015 Read More...

This past week, the FDA granted approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. A special diagnostic test is used to identify appropriate candidates for the drug. The most common side effects of Keytruda included fatigue, decreased appetite, shortness of breath or impaired breathing (dyspnea) and cough. Keytruda is also used to treat advanced skin cancer (melanoma) that has spread to other parts of the body or cannot be surgically removed.

FDA Approves Combination of Drugs for Pulmonary Arterial Hypertension

PAH is a life-threatening and debilitating disease characterized by constriction of the lung blood vessels Read More...

This past week, FDA approved the combined use of two drugs already established as effective in treating pulmonary arterial hypertension (PAH). Gilead's ambrisentan (Letairis) is an endothelin receptor antagonist indicated for the once-daily oral treatment of PAH. Tadalafil (Adcirca) is an oral PDE5 inhibitor that was initially approved for PAH in 2009. Researchers have now shown that combining these agents may further delay the progression of PAH over the long term for patients who are new to therapy. Based on studies, patients receiving the combined treatments have improved exercise capabilities and are less likely to have disease progression or hospitalization.

Opdivo Plus Yervoy Combo Wins Approval for Metastatic Melanoma

This is the first approval of a regimen of two immuno-oncology agents in cancer Read More...

FDA has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. Opdivo and Yervoy are immune checkpoint inhibitors that target different but complementary checkpoint pathways (PD-1 and CTLA-4). Among patients (n=109) with BRAF wild-type melanoma, the combined regimen demonstrated a significantly superior response rate of 60% vs. 11% with Yervoy alone. In clinical trials, the median progression-free survival was 8.9 months with the combined regimen and 4.7 months with Yervoy alone. This trial provides clinical rationale for targeting the immune system with two immunomodulator cancer agents in metastatic melanoma.

All Natural Alternatives for Erectile Dysfunction: A Risky Proposition

These products are often sold online, individually in gas stations or vending machines, or in retails shops Read More...

Products marketed as dietary supplements or foods to boost a man’s sexual performance or stimulation, and labeled as “all natural” or “safe” may actually be products tainted with prescription drugs. In fact, FDA lab tests have uncovered close to 300 products that contain ingredients not clearly marked on the label, including prescription drugs used in the treatment of erectile dysfunction such as  Viagra, Cialis and Levitra. Even more alarming, these fraudulent products may contain multiple unlisted drug ingredients - approved or unapproved - and may dangerously interact with other legitimate medications.