Drug OK'd for advanced prostate cancer
The FDA approved Ferring Pharmaceuticals Inc.'s injectable drug degarelix, the first new drug approved in several years for prostate cancer. The drug's trade name has not yet been determined.
Degarelix is a gonadotropin-releasing hormone (GnRH) receptor inhibitor approved for patients with advanced prostate cancer. Unlike other medications in this class, however, degarelix does not cause an initial surge in testosterone production before lowering testosterone level. This surge can temporarily prompt tumor growth instead of inhibiting it.
Studies show that degarelix is at least as effective as leuprolide acetate (Lupron Depot) in sustaining castrate levels or lowering testosterone and had a statistically significant faster reduction of testosterone.
In a clinical trial of degarelix, the most frequently reported adverse reactions included injection-site reactions, hot flashes, increased weight, fatigue, and increases in some liver enzymes.
Cholesterol management with fibrate, statin
Abbott's fenofibric acid (Trilipix) has been approved for use along with diet to help lower triglycerides and low-density lipoprotein (LDL) cholesterol in adult patients with lipid problems. The delayed-release medication is the first and only fibrate to be approved for this indication.
The approval is based on clinical trials of Trilipix in 12-week studies that evaluated the efficacy and safety of the drug in combination with commonly prescribed statins in nearly 2,700 patients with mixed dyslipidemia. Combination therapy significantly improved high-density lipoprotein (HDL) cholesterol and triglycerides compared with statin therapy alone and significantly improved LDL cholesterol compared with Trilipix alone. All of the combinations and the statins had clinically meaningful reductions in LDL cholesterol.
Zolpidem tartrate now available as an oral spray
NovaDel Pharma Inc. has received approval to market 5 and 10 mg zolpidem tartrate oral spray (Zolpimist) for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpimist contains the same active ingredient as Ambien and uses NovaDel's proprietary NovaMist oral spray technology.
Studies comparing Ambien tablets and Zolpimist in young and elderly healthy volunteers demonstrated bioequivalence between the two products.
Due to the rapid action of Zolpimist, patients should take it immediately before bedtime and be prepared to get a full night's sleep (7 to 8 hours). Patients should use extreme care or avoid engaging in activities requiring full alertness. Complex behaviors such as somnambulism, including driving or eating while not fully awake, with amnesia for the event, as well as cases of severe allergic reactions have been reported in patients using sedative hypnotics.
Tainted weight-loss pills prompt warning
The FDA is alerting consumers not to purchase or consume over 25 different weight-loss pills. A full list of the weight-loss products is available at http://www.fda.gov/cder/consumerinfo/weight_loss_products.htm.
An FDA analysis found that the undeclared active pharmaceutical ingredients in some of the products include the controlled substances sibutramine, rimonabant (approved in Europe as Acomplia), phenytoin, and phenolphthalein. Some of the amounts of active pharmaceutical ingredients far exceed the FDA-recommended levels. Health risks posed by these products can be serious, the FDA notes. For example, sibutramine can cause hypertension, seizures, tachycardia, palpitations, MI, or stroke, and its safety has not been established in pregnant or lactating women or in children under 16 years of age.