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Weekly Drug News Round-Up: March 22, 2017

FDA Approves Xadago for “Off” Episodes in Parkinson’s Disease

Roughly one million Americans have Parkinson’s Disease, a neurological movement disorder currently without a cure Read More...

This week the FDA cleared for marketing Xadago (safinamide) tablets, a dual selective monoamine oxidase inhibitor and glutamate inhibitor for use in Parkinson’s disease. Xadago, from Newron Pharmaceuticals, is indicated as an add-on treatment to levodopa/carbidopa (Sinemet) in patients who experience “off” episodes. An “off” episode is a time when a patient’s levodopa has worn “off”, causing an increase in Parkinson’s disease symptoms, such as tremor, stiffness, and difficulty walking. In clinical trials, patients receiving Xadago has more “on” time, meaning their Parkinson’s symptoms were reduced without dyskinesia (involuntary movements), compared to the placebo group. Common side effects included uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep (insomnia).

Juvéderm Vollure XC Can Offer Extended Treatment of Laugh Lines

Nasolabial folds (laugh lines) are the number one dermal treatment area Read more...

Juvéderm Vollure XC (hyaluronic acid gel) from Allergan has been FDA-approved to treat moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over 21 years. Juvederm is an injectable hyaluronic acid gel dermal filler. This latest product has been shown to last up to 18 months in a majority of subjects (59%). Patients also reported a high rate of satisfaction (68-82%) with the product. The most common side effects are temporary injection site reactions like swelling, bruising, firmness lumps/bumps, redness, pain, discoloration, and itching, which usually resolve within 1 week. Juvéderm Vollure XC will be available commercially in April 2017.

Newer Hepatitis C Virus Agents Come Close to a Cure

A significant barrier to treatment with these drugs is costs, ranging from $55,000 to more than $150,000 Read More...

New research published this week in the Annals of Internal Medicine examines the effectiveness of the latest oral treatments for chronic hepatitis C virus (HCV). Researchers combed over data from 42 published clinical trials of adults with chronic HCV infection involving interferon-free treatment regimens of two or more medicines. The newer agents, for example Harvoni (ledipasvir/sofosbuvir), Epclusa (sofosbuvir/velpatasvir), and Zepatier (elbasvir and grazoprevir) can lead to a cure in most, but not all people. Six of the treatment regimens led to remission of the virus in 95% of patients with the most common strain, according to the study; the drugs were well tolerated.

Pradaxa Tops Warfarin For Surgical Procedure for Irregular Heart Rhythm

A new study from the New England Journal of Medicine looks at risk of a major bleed Read More...

Patients undergoing a surgical procedure to treat an irregular heartbeat known as atrial fibrillation are less likely to suffer problematic bleeding when given the blood thinner Pradaxa (dabigatran) instead of warfarin, a new study finds. Six hundred patients received catheter ablation to correct atrial fibrillation and received either warfarin or Pradaxa for 4 to 8 weeks before the procedure, during, and for 8 weeks afterwards. The risk of major bleeding with warfarin was 7%, whereas the risk for  Pradaxa was 2%, a 77 percent lower risk. Still in question: whether the new blood thinners like Xarelto (rivaroxaban) or Eliquis (apixaban) would have the same results as Pradaxa.

Heart Drug Digoxin May Raise Death Risk for Some Patients: Study

Patients whose digoxin levels were greater than 1.2 ng/mL had a 56 percent increased risk of death Read More...

A new observational study of 18,000 atrial fibrillation patients from Duke University suggests patients with AF newly started on digoxin may be better off with other treatments. In the 7% of patients who began digoxin treatment after the study started, death risks -- particularly sudden death -- were substantially higher, occurring primarily in the first 6 months. Researchers state that other appropriate treatments, instead of digoxin, should be given to these patients. There was no significant association between digoxin use and death risk among patients who were already taking digoxin, probably because they were a group that tolerated the drug. The study was observational; follow-up clinical trials are need to determine causation.