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Weekly Drug News Round Up - October 21, 2015

Praxbind Approved as Reversal Agent for Pradaxa Bleeding

Praxbind labeling recommends patients restart their anticoagulant therapy as soon as medically appropriate Read More…

One of the major drawbacks with the newer oral anticoagulant Pradaxa (dabigatran) was that there was no reversal agent for bleeding. This problem was addressed last week with approval of Praxbind (idarucizumab). Praxbind is an intravenous injection that binds to Pradaxa to neutralize its effect and control bleeding. In a study of 123 patients taking Pradaxa who received Praxbind due to uncontrolled bleeding or the need for emergency surgery, the anticoagulant effect of Pradaxa was fully reversed in 89 percent of patients within four hours of treatment. Common side effects have included headache, low potassium (hypokalemia), confusion, constipation, fever and pneumonia.

Tris Pharma’s Dyanavel XR Wins FDA Approval for ADHD

Dyanavel XR is the first, extended-release amphetamine-based oral liquid for the treatment of ADHD Read More…

The U.S. Food and Drug Administration (FDA) has approved Dyanavel XR (amphetamine), extended-release oral suspension for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years and older. Amphetamine is a central nervous system (CNS) stimulant utilized in the treatment of ADHD. A specialized delivery system in Dyanavel XR allows continuous release of amphetamine throughout the day. The most common adverse reactions reported in studies were epistaxis (nose bleed), allergic rhinitis and upper abdominal pain. Dyanavel XR is expected to be commercially available in 2016. Learn more about ADHD with this slideshow.

Coagadex First Approved Coagulation Factor for Rare Bleeding Disorder

Factor X protein activates enzymes to help with normal blood clotting in the body Read More...

Factor X deficiency is an inherited disorder where the blood does not clot adequately. The FDA has approved Coagadex (coagulation factor X [human]), a human factor X (10) concentrate for the treatment of hereditary factor X deficiency. Coagadex is used in patients 12 and older with hereditary Factor X deficiency for control of bleeding episodes, and for perioperative management of bleeding in patients with mild hereditary Factor X deficiency. Coagadex is the first coagulation factor replacement therapy approved for these patients. Coagadex is designated an orphan drug for rare disease treatment. Coagadex was also granted fast track designation and priority review.

Enstilar Approved for Treatment of Plaque Psoriasis

Plaque psoriasis (psoriasis vulgaris) is the most common form of psoriasis Read More...

This week LEO Pharma announced approval of Enstilar (calcipotriol/betamethasone dipropionate) Foam, a once-daily, alcohol-free topical treatment for plaque psoriasis in adults. Enstilar is a topical corticosteroid and vitamin D analogue combination. In pivotal Phase 3 trials, over half of patients treated with Enstilar were “Clear” or “Almost Clear” by Week 4 as measured by the 2-step Investigator Global Assessment (IGA) improvement score. Common side effects with calcipotriol/betamethasone dipropionate may include dry skin, itching, mild rash, or changes in skin color. Follow along with this slideshow to learn more about treating plaque psoriasis.

Naproxen As Good As Narcotics for Low Back Pain: Study

Some people may need to speak to their doctor about optimizing their OTC NSAID doses to a higher dose Read More...

Acute low back pain is the scourge of millions of Americans. A new study in the Journal of the American Medical Association (JAMA) shows that prescription doses of naproxen - an anti-inflammatory NSAID available either OTC (Aleve) or by prescription - works as well as narcotic painkillers or muscle relaxants for back pain. In the study, researchers compared prescription strength naproxen to the use of naproxen plus oxycodone/acetaminophen (Percocet) or the muscle relaxant cyclobenzaprine. Patients who took a combination of drugs fared no better than when they took naproxen alone, the researchers said. In general, narcotic side effects outweigh benefits when used for low back pain.