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Monthly News Roundup - June 2014

Afrezza Inhaled Insulin FDA-Approved for Type 1 and Type 2 Diabetics

The U.S. Food and Drug Administration (FDA) has approved Afrezza (insulin human) Inhalation Powder to improve glycemic control in adult diabetics. Afrezza is an ultra rapid-acting inhaled insulin that is administered with meals. Afrezza was evaluated in 24-week studies in both type 1 and type 2 diabetic patients. In type 1 patients also using long-acting insulin, Afrezza effectiveness to lower blood sugar (HbA1c) provided less HbA1c reduction than insulin aspart, and the difference was statistically significant. In type 2 patients using oral antidiabetic agents, Afrezza did significantly lower HbA1c compared to a placebo group. Exubera, another inhaled insulin, was withdrawn in 2007 due to lack of sales.

Sivextro Approved for Acute Bacterial Skin and Skin Structure Infections

The U.S. Food and Drug Administration (FDA) has approved Cubist Pharmaceuticals' Sivextro (tedizolid phosphate), a new antibacterial drug for serious and possibly life-threatening skin infections. Sivextro, available in oral and intravenous forms, is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by bacteria such as Staphylococcus aureus (including methicillin-resistant strains), various Streptococcus species, and Enterococcus faecalis. In clinical trials, Sivextro was as effective as linezolid for skin and skin structure infections. Common side effects included nausea, headache, diarrhea, vomiting and dizziness. On May 23, the FDA also approved Dalvance (dalbavancin) to treat patients with ABSSSI.

FDA Approves Valeant’s Jublia for the Treatment of Onychomycosis

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 treatments for onychomycosis include Penlac Nail Lacquer (ciclopirox) and oral antifungals like Lamisil (terbinafine).

Bunavail Approved for Treatment of Opioid Dependence

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

The U.S. Food and Drug Administration (FDA) has 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.

Posted: June 2014