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Weekly Drug News Round Up - May 20, 2015

FDA Approves Janssen’s Invega Trinza for Schizophrenia

Schizophrenia affects approximately 2.4 million U.S. adults

Compliance with medications for schizophrenia patients is often difficult and can lead to treatment failure. The U.S. Food and Drug Administration has approved Invega Trinza (three-month paliperidone palmitate), an atypical antipsychotic injection given every three months. However, before patients can start the every 3-month regimen, they must be adequately treated for at least four months with Invega Sustenna, a paliperidone palmitate injection given once per month. As published in JAMA Psychiatry, a phase 3 study showed that 93 percent of patients treated with Invega Trinza did not experience a significant return of schizophrenia symptoms. Janssen anticipates that Invega Trinza will be commercially available by mid-June.

Treximet Approved For Migraines in Children 12 Years and Older

Additional treatment options are needed for teens, as migraines can often lead to problems in school and social growth Read More…

Treximet (sumatriptan and naproxen sodium) was previously approved in 2008 for the acute treatment of migraine in adults. However, up to 23 percent of pediatric patients over 11 years of age suffer from migraine headaches, too. The FDA has now approved Treximet for the acute treatment of migraine with or without aura in pediatric patients 12 years of age and older. The recommended dose for pediatric patients is a single tablet of Treximet 10/60 mg (sumatriptan 10 mg and naproxen sodium 60 mg) per 24-hour with a maximum dose of 85/500 mg per 24-hour period.

FDA Issues Safety Warning on Type 2 Diabetes Drug Class

FDA continues to investigate the warning issue and will determine whether label changes are needed Read More…

The U.S. Food and Drug Administration has issued a drug safety communication warning about a potential risk of ketoacidosis (too many blood acids called ketones) with the use of a type 2 diabetes drug class known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. Drugs in the SGLT-2 class include canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance). Patients should be aware of ketoacidosis symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Do not stop or change your diabetes medicines without first talking to your prescriber.

Cystic Fibrosis Combo Targets Common Genetic Defect

Kalydeco is already approved in the U.S for treating a small subset of CF patients Read More...

Cystic fibrosis (CF) is a genetic disease that causes thick, sticky mucus to form in the lungs, pancreas and other organs. Lung infections are common. A new study published in New England Journal of Medicine shows that medicines that target the genetic mutations in CF - ivacaftor (Kalydeco) plus lumacaftor - are lending hope. Kalydeco was already approved in 2012. The study found the combination, called Orkambi, was safe and effective for people with two copies of a particular cystic fibrosis gene mutation called F508del. The investigational combo could treat a larger population of CF patients in the U.S., around 15,000, if FDA-approved.

Vitamin B Linked to Lower Risk of Skin Cancer

Skin cancer is the most common form of cancer in the U.S., with roughly 5 million cases treated every year Read More...

With summer coming up, sun protection for your skin may be a hot topic on your mind. A new study from Australian researchers reports that the use of inexpensive, over-the-counter Vitamin B (nicotinamide, also known as niacinamide) was linked to a reduction of non-melanoma skin cancers by 23 percent when taken twice daily. Previous studies show that nicotinamide can provide an energy boost to skin cells, which can strengthen the skin's immune system and help prevent skin cancer. However, the study is preliminary and researchers cannot yet say if everyone would benefit from vitamin B to protect their skin.