FDA actions
FDA actions
The FDA has approved a delayed-release form of prednisone for the treatment of endocrine, inflammatory, and neoplastic conditions. Delayed-release prednisone should be taken once a day with timing to be determined by the disease being treated. For example, 10 p.m. dosing is recommended for rheumatoid arthritis, as it is more effective than immediate-release prednisone taken in the morning for treating morning stiffness associated with the disease. Dosing is based on the theory that both cytokines and endogenous cortisol follow a circadian rhythm, and that dosing the drug based on the condition being treated may afford more effective treatment than immediate-release prednisone. The new product delays the release of prednisone by approximately 4 hours. Side effects are the same as short-acting prednisone. Delayed-release prednisone will be marketed as RAYOS by Horizon Pharma.
The FDA has approved a new chlorofluorocarbon (CFC)-free, over-the-counter inhaled racepinephrine product for the treatment of asthma. The new product takes the place of the banned Primatene Mist, which was taken off the market at the end of 2011 because it contained CFCs. Inhaled epinephrine has been used for the treatment of asthma for more than 100 years. Marketed as Asthmanefrin, the new product will be sold as a starter kit and refill package. The starter kit will include 10 vials of racepinephrine along with the EZ Breathe Atomizer. The refill kit will include 30 vials of the drug. The drug is not without controversy, however, with many asthma experts feeling that the side effects of epinephrine are serious and well-documented, and over-the-counter use goes against published guidelines for treating asthma. Asthmanefrin will be marketed by Nephron Pharmaceuticals.
The FDA has approved linaclotide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation. The drug is the first guanylate cyclase (GC-C) agonist that acts locally in the gut with minimal systemic exposure. The drug is taken once daily on an empty stomach at least 30 minutes before the first meal of the day. Safety and efficacy in the management of irritable bowel syndrome with constipation was established in two double-blind studies of nearly 1300 patients who were randomly assigned to linaclotide or placebo for 12 weeks. Patients taking the drug experienced more complete spontaneous bowel movements than those taking placebo. The drug should not be used in patients 17 years or younger. Linaclotide will be jointly marketed by Ironwood Pharmaceuticals and Forest Pharmaceuticals as Linzess.
Montelukast (Singulair), Merck's popular asthma and allergy medication, will soon be available as a generic. The leukotriene receptor antagonist will be manufactured by 10 generic companies in tablet form, oral granules, and chewable tablets. The FDA warns that montelukast should not be used for relief of sudden asthma attacks and further warns that patients should contact a clinic immediately if they are experiencing behavior and mood-related changes such as aggression, depression, or hallucinations.
The FDA has approved the first generic version of pioglitazone (Actos). The drug is approved along with diet and exercise to improve blood sugar control in adults with type 2 diabetes. This happens as thiazolidinediones have generally fallen out of favor for use in type 2 diabetes due to side effects including worsening heart failure and edema. The FDA also recently issued a warning for pioglitazone regarding increased risk of bladder cancer if the drug is taken for more than 1 year. The first generic pioglitazone will be manufactured by Mylan Pharmaceuticals.