Content about Pharmacology

PHILADELPHIA — The Food and Drug Administration has approved an attention deficit hyperactivity disorder drug for use in adolescents.

British drug maker Shire announced Monday the approval of Vyvanse (lisdexamfetamine dimesylate) capsules for patients aged 13 to 17. The drug was already approved for children ages 6 years to 12 years and adults.

MORRISTOWN, N.J. — On Tuesday, Lifetime Television’s program “The Balancing Act” will feature an appearance from Sarita Thapar, director of medical affairs for Actavis, to discuss the benefits of the company’s pediatric suppository FeverAll, Actavis announced last week.

ALEXANDRIA, Va. — In a ruling hailed by retail pharmacy leaders, the Department of Defense now is insisting that drug manufacturers extend the same discounts for prescription drugs sold at community pharmacies that the military gets for medicines dispensed through base dispensaries or mail order.

NEW YORK —The often wide gap between what consumers will pay out of pocket for a branded versus a generic drug is one big factor driving the continually rising demand curve for me-too medicines.

CHICAGO — A drug made by Pfizer may help decrease the risk of cardiovascular death or heart failure hospitalization in patients with chronic heart failure, according to a late-stage clinical study.

The “Emphasis-HF” study — funded by Pfizer, published online in the New England Journal of Medicine and presented at the American Heart Association scientific sessions in Chicago — found that adding Inspra (eplerenone) to standard therapies reduced the risks compared with placebo.

WHAT IT MEANS AND WHY IT’S IMPORTANT — There’s been quite an uproar following healthcare reform’s flexible spending account proposal that in January will force consumers to spend upward of $40 on doctor visit co-pays in order to save some $2.50 for every $10 spent on nonprescription items.

NEW YORK According to a recently published Dow Jones report, state-funded tobacco-prevention programs quickly are becoming the latest casualty of constricting state budgets, prompting concern among public health groups around the nation's progress toward getting adult smokers to quit.

The number of adults who smoke has remained relatively steady since 2004 — 20.6% of the population were smokers in 2009.

SAN DIEGO Two drug makers conducting a late-stage clinical trial of a drug for treating overweight and obese patients said the drug produced significant weight loss in patients with Type 2 diabetes.

Arena Pharmaceuticals and Eisai reported results of the one-year “BLOOM-DM” phase-3 trial of the drug lorcaserin, showing that a significant number of patients lost 5% to 10% of their weight by the end of the trial. Patients taking the drug also showed improvements in blood sugar levels, compared with those taking placebo.

NEW YORK Loss of patent protection for branded drugs and subsequent competition from generics could save the U.S. healthcare system $70 billion or more over the next four years, according to published reports.

Reuters reported IMS Health SVP Murray Aitken as saying at the Reuters Health Summit that generics also would increase their dominance in terms of prescriptions dispensed, increasing from 77% during the first half of this year to perhaps 85% by 2014.

SILVER SPRING, Md. The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of generic drugs, testified Wednesday at a hearing sponsored by the Food and Drug Administration to collect public and industry input on the implementation of the regulatory approval pathway for follow-on biologics included in the healthcare-reform bill.

THOUSAND OAKS, Calif. Amgen's SVP research and development, Joe Miletich, urged members of a Food and Drug Administration panel to establish approval standards for biosimilars that ensure patient safety and follow a science-based approach.

“Put patients first and sound policy will follow,” Miletich said. “Amgen believes biosimilars have a meaningful role to play in the healthcare system. However, dissimilar — unlike generic drugs — are not identical to the innovative biological products.”