Government agencies draft plan to curb opioid abuse
WASHINGTON — The Obama administration is looking to curb the growing national epidemic of prescription painkiller abuse, according to a plan unveiled Tuesday.
Elements of the plan include expansion of state-based prescription drug monitoring programs, recommendation of convenient and environmentally responsible drug-disposal methods, education and reduction of doctor shopping.
According to the Food and Drug Administration, more than 33 million Americans ages 12 years and older have misused long-acting and extended-release opioids, and opioids were involved in nearly 50,000 emergency room visits in 2006. Opioids include such drugs as oxycodone, hydromorphone and morphine.
“The toll our nation’s prescription drug abuse epidemic has taken in communities nationwide is devastating,” White House Office of National Drug Control Policy director Gil Kerlikowske said. “We share a responsibility to protect our communities from the damage done by prescription drug abuse.”
Added FDA commissioner Margaret Hamburg, “Opioid drugs have benefit when used properly and are a necessary component of pain management for certain patients, but we know that they pose serious risks when used improperly — with serious negative consequences for individuals, families and communities.”
As part of the plan, the FDA is announcing a risk evaluation and mitigation strategy for all extended-release opioids focused on educating doctors about proper pain management, patient selection and other requirements. Companies that make opioids must propose a REMS plan within 120 days, and doctor training, patient counseling and other risk-reduction measures developed are expected to become effective by early next year.
Mylan launches generic Famvir
PITTSBURGH — Mylan has launched a generic drug for treating herpes, the company said Wednesday.
Mylan announced the launch of famciclovir tablets in the 125-mg, 250-mg and 500-mg strengths. The drug is a generic version of Novartis’ Famvir.
Branded and generic versions of the drug had sales of $196 million in 2010, according to IMS Health.
Rituxan OKed as treatment for two inflammatory diseases
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.
The FDA approved Rituxan (rituximab), in combination with a type of steroid known as glucocorticoids, to treat patients with Wegener’s granulomatosis and microscopic polyangiitis. Both disorders cause inflammation of the blood cells, also known as vasculitis, which can lead to tissue damage. WG mostly affects the respiratory tract, while MPA affects the kidneys, lungs, nerves, skin and joints. Both are considered orphan diseases because they affect fewer than 200,000 people in the United States, but their causes remain unknown.
“This new indication for Rituxan provides the first approved therapy for these two orphan diseases,” FDA Office of Drug Evaluation II director Curtis Rosebraugh said.