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.
Merck drug approved for preventing fungal infections in immunosuppressed patients
WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a new tablet form of an antifungal drug made by Merck, the company said Tuesday.
Merck announced the FDA approval of Noxafil (posaconazole) 100-mg delayed release tablets. The company also markets a 40-mg-per-milliliter oral suspension form of the drug. The new tablet formulation is designed to be taken in two 300-mg doses on the first day, followed by a 300-mg dose once per day.
The drug is approved for preventing invasive Aspergillus and Candida fungus infections in patients aged 13 and older who are at high risk of developing them due to depressed immune function resulting from hematopoietic stem cell transplants and low white blood cell counts caused by chemotherapy, a condition known as neutropenia.