PHARMACY

CDC: State data shows opioid prescribing behavior needs to change

BY David Salazar

ATLANTA — A new report from the Centers for Disease Control and Prevention is shining light on steps that can be taken to prevent opioid abuse and misuse. Using 2013 data from state prescription drug monitoring programs from eight states, the CDC found that prescribing practices between states vary drastically. Additionally, demographic differences between states do not entirely explain the variation, and the CDC notes that the real way to fix the issue is to improve prescribing practices.

“A more comprehensive approach is needed to address the prescription opioid overdose epidemic, including guidance to providers on the risks and benefits of these medications,” Dr. Debra Houry, director of the CDC’s National Center for Injury Prevention and Control, said.

One of the largest contributors to opioid abuse is overprescribing done by a small number of prescribers whose prevalence is different between states. For example, in Del., the top 1% of prescribers wrote 25% of the state’s opioid prescriptions, compared with 1-in-8 prescriptions in Maine by the top 1%. Equally variant between the states was the prevalence of patients paying with cash, which the CDC notes is a sign of abuse — differing almost threefold between five states reporting that data.

“Every day, 44 people die in American communities from an overdose of prescription opioids and many more become addicted,” CDC director Dr. Tom Frieden said. “States are on the frontline of witnessing these overdose deaths.  This research can help inform their prescription overdose prevention efforts and save lives.”

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Alembic Pharmaceuticals debuts in U.S. with Namenda generic

BY David Salazar

GUJARAT, India — Alembic Pharmaceuticals has kicked off its operations in the United States with the launch of its memantine hydrochloride tablets, a generic of Namenda. The drug, which is indicated to treat Alzheimer’s diseases and dementia, will be available in 5- and 10-mg dosage strengths.

“We are very excited about the launch of Memantine tablets and the opportunity to provide patients an affordable therapeutic option” Craig Salmon, Alembic’s president of U.S. operations said.  “This is an important step for Alembic and the first of many new products to be launched into the U.S. market in the immediate future.”   

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FDA approves Tris Pharma’s Dyanavel XR

BY David Salazar

MONMOUTH JUNCTION, N.J. — Tris Pharma on Tuesday announced that it had received approval from the Food and Drug Administration for its Dyanavel XR (amphetamine) extended-release oral suspension. Dyanavel is indicated as a once-daily treatment for attention deficit/hyperactivity disorder in children ages 6 and older.

“Dyanavel XR is the first and only once-daily, extended-release amphetamine oral suspension for the treatment of ADHD,” Tris’ chief medical officer Dr. Sally Berry said. “Amphetamines are well-established as effective treatment for ADHD.  Dyanavel  XR offers physicians a new pediatric-friendly dosing option that couples fast onset with a long duration of effect suitable for school-aged children.”

The drug is expected to be available in 2016, the company said. 

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