PHARMACY

Acadia Pharmaceuticals can apply for approval of Parkinson’s disease psychosis drug early

BY Alaric DeArment

SAN DIEGO — The Food and Drug Administration is granting an expedited application process to a company that has developed a treatment for a condition related to Parkinson’s disease, meaning that it can cancel a planned late-stage clinical trial, the company said.

Acadia Pharmaceuticals announced that the FDA had allowed it to move forward in applying for approval of the drug pimavanserin for the treatment of Parkinson’s disease psychosis, or PDP, based on data from an already complete phase-3 trial and other data. The decision by the FDA means the company no longer perform another phase-3 trial that it had planned.

"We are very pleased with the outcome of our meeting with the FDA, which we expect will reduce substantially both the time and cost of our PDP development program," Acadia CEO Uli Hacksell said. "This represents another important step toward our goal of bringing pimavanserin to the market as an innovative therapy for Parkinson’s patients who suffer from the psychosis frequently associated with this disease."

Of the 1 million people in the United States with Parkinson’s disease, about 60% develop PDP, a condition that causes visual hallucinations and delusions, according to the National Parkinson’s Foundation. There is currently no FDA-approved treatment for PDP, Acadia said.

 

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FDA investigation finds widespread problems at compounding pharmacies

BY Alaric DeArment

SILVER SPRING, Md. — An inspection of more than two-dozen compounding pharmacies by Food and Drug Administration officials has found widespread problems with sanitation and sterilization practices, FDA commissioner Margaret Hamburg wrote in a blog post on the agency’s website Thursday.

The agency inspected 31 pharmacies that were known to have engaged in sterile compounding of sterile drugs. At all but one of the pharmacies, inspectors found problems such as mold and rust in clean rooms, black particles floating in supposedly sterile drugs, technicians using their bare hands to handle products that require latex gloves and wearing nonsterile lab coats. In at least two instances, FDA officials had to get administrative warrants to obtain access to pharmacies’ records, and U.S. Marshals had to accompany the agency’s investigators to one pharmacy.

In traditional pharmacy compounding, a pharmacist mixes drugs according to a physician’s prescription, usually oral solids, liquids, ointments and suppositories, which can be done from a pre-made kit or with an existing drug, such as the common practice of using capsules of Genentech’s Tamiflu (oseltamivir) to create a drinkable liquid formulation for children. But sterile compounding usually involves mixing drugs for injection, such as chemotherapy and biotech drugs, and it requires strict adherence to sterilization practices.

Hamburg has called for giving the FDA increased authority over compounding pharmacies in the wake of a nationwide outbreak of fungal meningitis linked to the New England Compounding Center of Framingham, Mass. An inspection by health officials of that pharmacy found widespread disregard for sterile practices as the pharmacy, according to officials, had effectively become a drug manufacturer.

According to the Centers for Disease Control and Prevention, the meningitis outbreak has sickened 733 and resulted in 53 deaths.

 

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Study finds wide disparities in antibiotic prescribing rates between South, Midwest

BY Alaric DeArment

NEW YORK — Research has indicated that about half of antibiotic prescriptions are unnecessary, raising concerns about the growth of bacteria resistant to them, but a new study by researchers at the Centers for Disease Control and Prevention also finds that prescriptions are highest in several states in the South and Midwest.

The study, published Thursday in the New England Journal of Medicine, was based on a database maintained by IMS Health that includes a sample of more than 70% of U.S. prescriptions.

The study found 258 million courses of antibiotics prescribed in 2010, or 833 prescriptions per 1,000 people. Prescribing rates in the South were 936 per 1,000 people, compared with 639 in the West.

The highest rates — ranging from 996 to 1,237 prescriptions per 1,000 people — were found in Alabama, Mississippi, Louisiana, Arkansas, Tennessee, Kentucky and West Virginia, as well as the Midwestern states of Indiana and North Dakota. The lowest rates were found in Washington, Oregon, California, Alaska, Hawaii, Colorado, Vermont and New Hampshire.

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