FDA accepts application for GERD drug in children
WOODCLIFF LAKE, N.J. — The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.
Eisai said the FDA accepted its application for AcipHex delayed-release sprinkle capsules in the 5-mg and 10-mg strengths for healing of gastroesophageal reflux disease, and maintenance of healing of GERD and improvement of symptoms in children ages 1 year to 11 years.
The FDA expects to have the application reviewed by March 27, 2013. The drug is currently approved in the 20-mg strength for adolescents and adults.
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Surprise! Rx medicines lower overall health costs
Amid the glacial pace of change in government and health policy, congressional number crunchers have finally acknowledged an indisputable fact long known to health and pharmacy experts: prescription medicines save money.
It seems obvious enough. But it was only last week, near the end of November, that the Congressional Budget Office unveiled the results of a new study showing that greater prescription drug access and utilization can reduce health care costs in other areas, including hospitalizations.
To put it in the CBO’s own words, “Greater prescription drug use by Medicare beneficiaries reduces Medicare’s spending for medical services.” Researchers based that conclusion on a review of dozens of recent studies of the impact of prescription drug therapy on hospitalization rates and other outcomes.
Better late than never. The CBO’s report, “Offsetting Effects of Prescription Drug Use on Medicare’s Spending for Medical Services,” is a step beyond previous CBO studies “that found insufficient evidence of an ‘offsetting’ effect of prescription drug use on medical services spending,” says Drug Store News reporter Alaric DeArment in a Nov. 30 report.
The savings found in the CBO study aren’t much. “CBO estimates that a 1% increase in the number of prescriptions filled by beneficiaries would cause Medicare’s spending on medical services to fall by roughly one-fifth of 1%,” the agency reports. But its findings are based on only a narrow set of criteria tracking the correlation between increased drug utilization and overall medical savings. And as independent pharmacy leader Doug Hoey noted last week, “CBO’s new analysis represents the tip of the iceberg in terms of the savings independent community pharmacists can produce for Medicare and other health plans.
"CBO examined only the quantity of prescriptions filled, not the qualitative benefits of strong patient-pharmacist relationships in helping patients take their medication appropriately,” said Hoey, CEO of the National Community Pharmacists Association.
I’d like to hear other examples of how prescription drug therapy and medication therapy management – delivered in person by pharmacists – is helping patients lead healthier lives and stay out of the hospital. Please share your experiences and your thoughts about the validity and scope of the CBO’s findings.
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Merck starts Alzheimer’s drug trial
WHITEHOUSE STATION, N.J. — Merck has started a clinical trial that it hopes will eventually enroll 1,700 patients to evaluate an experimental drug for Alzheimer’s disease, the company said.
Merck announced the start of "EPOCH," a combined phase-2 and phase-3 study of the drug MK-8931, a 78-week trial in which patients will take either the drug in the 12-mg, 40-mg or 60-mg doses or placebo.
"Merck is committed to advancing the understanding and treatment of Alzheimer’s disease," Merck Research Labs SVP and head of neuroscience and ophthalmology Darryle Schoepp said. "As the global health and financial burden of Alzheimer’s disease grows, innovative research is critically needed, and we need to accelerate this research wherever possible."