New migraine medication approved
The FDA has approved diclofenac potassium for oral solution (Cambia) for the acute treatment of migraine with or without aura.
The novel, water-soluble, buffered diclofenac potassium powder is the only prescription nonsteroidal anti-inflammatory drug available for the treatment of migraine. Its patented absorption-enhancing technology is designed for fast, effective relief from the symptoms of migraine. Diclofenac enters the bloodstream quickly and readily, achieving peak plasma concentrations and providing rapid onset of pain relief via oral therapy without increasing the patient's total exposure to diclofenac.
The FDA approved diclofenac based on results of two Phase 3 clinical trials showing that the drug was superior to placebo in all four required end points for migraine: pain, nausea, photophobia, and phonophobia. Both studies also showed that reduction in pain intensity was significantly greater in the diclofenac-treated group than in the placebo group as early as 5 minutes after treatment.
Cancer drug withdrawn from the market
Pfizer has voluntarily withdrawn gemtuzumab ozogamicin (Mylotarg), a treatment for patients with acute myeloid leukemia (AML), from the U.S. market. The company took the action at the request of the FDA after results from clinical trials raised new concerns about the drug's safety and because it failed to demonstrate clinical benefits to patients enrolled in the trial.
Gemtuzumab ozogamicin was approved to treat patients ages 60 and older with recurrent AML who weren't considered candidates for other chemotherapies. Patients currently receiving gemtuzumab ozogamicin may complete their therapy following consultation with a healthcare provider.
Postmenopausal osteoporosis drug approved
The FDA has approved denosumab (Prolia) for the treatment of osteoporosis in postmenopausal women who are at high risk for fracture. High risk for fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant of other available osteoporosis therapies. Denosumab is given every 6 months in a 60-mg subcutaneous injection administered by a healthcare provider.
Denosumab was approved based on data from a Phase 3 clinical trial involving over 7,800 postmenopausal women with osteoporosis. Treatment with denosumab resulted in greater bone density, stronger bones, and reduced risk of vertebral, hip, and nonvertebral fractures measured at 3 years.
The drug is contraindicated in patients with hypocalcemia. In the clinical trial, serious infections leading to hospitalizations were reported more frequently in the denosumab-treated group. Serious skin infections, as well as infections of the abdomen, urinary tract, and ear, were more frequent in patients treated with denosumab.
did you know?
The Joint Commission has issued a "roadmap" to help hospitals advance effective communication, cultural competence, and patient- and family-centered care. Visit http://www.jointcommission.org/NR/rdonlyres/87C00B33-FCD0-4D37-A4EB-21791FB3969C to read the report.