QRxPharma refiles application for oxycodone, morphine combination pill Moxduo
BEDMINSTER, N.J. — QRxPharma has resubmitted its regulatory approval application for an opioid painkiller for which it has sought Food and Drug Administration approval since 2011, the company said Tuesday.
The Australian drug maker announced the resubmission of its application for Moxduo, a pill that combines oxycodone and morphine.The FDA is expected to schedule an advisory committee meeting to review the application for May 2014.
"We are confident that our refiled [new drug application] will confirm the validity of the data defining the product’s respiratory safety advantages, and we are hopeful that the FDA will view them favorably in their consideration of the benefits of immediate-release Moxduo as a therapeutic option for the millions of patients who suffer from acute pain," QRxPharma CEO and managing director John Holaday said.
FDA accepts Purdue Pharma’s application for Targiniq
STAMFORD, Conn. — The Food and Drug Administration has accepted Purdue Pharma’s regulatory approval application for a new opioid drug, Purdue said Tuesday.
The drug maker announced the FDA’s acceptance of its application for Targiniq (oxycodone hydrochloride; naloxone hydrochloride) controlled-release tablets. The drug combines oxycodone with the opioid agonist nalxone.
"This milestone brings us closer to offering an important treatment option for the management of chronic pain," Purdue SVP research and development Gary Stiles said. "It also represents another step forward in our effort to develop an array of products that incorporate abuse-deterrent features."
Symphony Health Solutions study predicts 5% rise in statin prescriptions following new cholesterol guidelines
SAN MATEO, Calif. – The number of patients receiving prescriptions for statins is expected to increase modestly following new cholesterol recommendations from the American College of Cardiology and the American Heart Association, according to a new report.
The report, by Symphony Health Solutions, estimated a 5% increase in the total number of patients prescribed statins, even though many media reports have predicted a doubling in statin use. About 36 million Americans are taking prescription cholesterol-lowering drugs, mostly statins, according to the market research firm. The study was based on a survey last week of 150 primary care physicians and cardiologists in the United States, as well as 100 cardiologists in Europe.
Other findings include almost universal awareness of the guidelines among U.S. physicians, as well as very high awareness in Europe, and positive reactions from physicians, who have indicated they are already treating patients in accordance with them. But despite the small increase in statin prescriptions that’s expected, physicians in the United States and Europe expect an increase of 55% to 60% in PCSK9 inhibitors, biotech drugs for treating cholesterol that are still in clinical trials, but have been found highly effective. At the same time, disagreement remains about the guidelines’ 10-year cardiovascular risk algorithm, with one-third of primary care physicians in the United States saying the 10-year risk is overestimated and one-quarter saying it’s underestimated.