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Weekly Drug News Round Up - June 11, 2014

FDA Approves Valeant’s Jublia for the Treatment of Onychomycosis

Jublia is available as a 10 percent solution with a built-in flow-through brush applicator Read More...

The U.S. Food and Drug Administration (FDA) has approved Jublia (efinaconazole), a topical triazole antifungal for the treatment of onychomycosis (fungal infection of the nail). Jublia is the first topical triazole approved for the treatment of onychomycosis of the toenails. For the pivotal studies, the primary endpoint was complete cure at Week 52. In two clinical studies, 17.8 percent and 15.2 percent of subjects treated with Jublia were completely cured, compared to 3.3 percent and 5.5 percent of subjects receiving the vehicle only. Other topical treatments for onychomycosis include Penlac Nail Lacquer (ciclopirox) and oral antifungals like Lamisil (terbinafine).

Bunavail Approved for Treatment of Opioid Dependence

BioDelivery Sciences International expects to launch Bunavail late in the third quarter of 2014 Read More...

Bunavail (buprenorphine and naloxone) is a buccal (inside of the cheek) opioid analgesic/opioid antagonist formulation approved by the U.S. Food and Drug Administration (FDA) for the maintenance treatment of opioid dependence. Bunavail should be used as part of a complete treatment plan to include counseling and psychosocial support. In a 12-week, Phase 3 clinical trial, 249 patients were converted from Suboxone sublingual tablet or film to Bunavail. Favorable safety and effectiveness for maintenance treatment of opioid dependence was shown by the low frequency of patients with positive urine tests for non-prescribed opioids over the 12-week period. Lower rates of constipation were reported with Bunavail, as well.

Orphan Drug Eloctate Receives FDA Approval

Hemophilia A is an inherited, sex-linked, blood clotting disorder that primarily affects males Read More...

This past week, the U.S. Food and Drug Administration (FDA) approved Eloctate, (antihemophilic factor [recombinant ] Fc Fusion Protein), a recombinant DNA derived, antihemophilic factor indicated for the treatment of patients with Hemophilia A. Eloctate is approved to help control and prevent bleeding episodes, manage bleeding during surgical procedures, and prevent or reduce the frequency of bleeding episodes (prophylaxis). Biogen Idec’s Eloctate received orphan-drug designation by the FDA because it is intended for treatment of a rare disease or condition.

Investigational Drug Naloxegol Helps to Relieve Opioid-Induced Constipation

Constipation is a common side effect experienced by patients taking strong opioids, or narcotics, for chronic pain Read More…

As reported this past week in the New England Journal of Medicine, AstraZeneca/Nektar’s naloxegol (Movantik) is designed to treat opioid-induced constipation caused by narcotic painkillers when regular laxatives are not helpful. Narcotics relieve pain by binding to certain receptors in the brain, but they also bind to receptors in the bowel, which raises the risk of constipation. Naloxegol, a peripherally-acting mu-opioid receptor antagonist, works by preventing the opioid from binding to receptors in the bowel, but not the brain. The FDA is expected to make an approval decision for naloxegol by September 16, 2014.

Reversible Heart Problems Linked to Herceptin

Women should have a cardiac assessment before starting trastuzumab, and cardiac follow-ups while taking it, according to experts Read More...

As many as one in 10 women taking the breast cancer drug Herceptin (trastuzumab) will experience some type of heart problem, according to new research. Trastuzumab may be given after surgery, chemotherapy and radiation for breast cancer. Researchers followed over 5,000 women in three different groups for an average of eight years. One group did not get trastuzumab, the second took it for one year (the current standard) and the third took it for two years. Congestive heart failure occurred in less than 1 percent of both drug groups taking active drug. After stopping the drug, the blood pumping problems resolved in over 80 percent of both groups receiving the drug.