AstraZeneca files new drug application, expanded use for another drug
WILMINGTON, Del. Anglo-Swedish drug maker AstraZeneca announced Monday that it had submitted an approval application to the Food and Drug Administration for a low-dose medication designed to reduce the risk of gastric and duodenal ulcers associated with low-dose aspirin.
The drug combines low-dose aspirin with esomeprazole, the active ingredient in the gastroesophageal reflux disease drug Nexium.
The company also submitted an application for an additional use of Nexium, also for duodenal and gastric ulcers associated with low-dose aspirin.
Investigational oxycodone formulation may discourage drug abusers
NEW ORLEANS Two drug companies may have developed a formulation of the painkiller oxycodone that discourages drug abusers.
King Pharmaceuticals and Acura Pharmaceuticals announced Friday that results from an oral abuse liability study of the drug Acurox (oxycodone hydrochloride and niacin) tablets indicate they are disliked among people with a history of opioid abuse, compared with oxycodone tablets alone when they swallow excess doses.
“The fact that people with a history of opioid abuse showed a disliking of Acurox tablets in excessive doses is an indication that the product is an important step in the development of medicines that are designed to deter common methods of abuse, such as over ingestion, while effectively managing pain,” lead study author and chief of Johns Hopkins Bayview Medical Center’s Center for Chemical Dependence Donald Jasinski said.
Results of the study were presented Friday at the American Society of Addiction Medicine’s Medical-Scientific Conference.
The two companies said the Food and Drug Administration had given Acurox priority review classification, and they expect to get a response from the FDA by June 30.
Amylin issues letter to shareholders regarding board of directors
SAN DIEGO Drug maker Amylin Pharmaceuticals is urging shareholders to reject prospective members of its board nominated by investor Carl Icahn and Eastbourne Capital Management.
Amylin sent a letter to shareholders Friday, signed by president and CEO Daniel Bradbury and lead independent director James Wilson, requesting that they instead vote for the company’s current board, saying the company was “poised to revolutionize” Type 2 diabetes treatment with the once-weekly formulation of the drug Byetta (exenatide), currently awaiting approval by the Food and Drug Administration. The FDA approved the twice-daily formulation of the drug in 2005.
“To ensure that you benefit from this value opportunity, it is imperative that Amylin has the best possible board of directors,” Bradbury and Wilson wrote in the letter.