PHARMACY

Study: Florida’s anti-opioid abuse laws show results

BY David Salazar

BALTIMORE — A study conducted by researchers at Johns Hopkins Bloomberg School of Public Health has found that Florida’s legislative efforts to curb opioid abuse seem to be having their desired effect. The study was published in JAMA Internal Medicine and looked into the efficacy of Florida’s Prescription Drug Monitoring Program and laws aiming to stop pill mills — clinics that dispensed or prescribed opioids recklessly. 
 
Researchers studied a group of 431,890, 296 pharmacies and 2.6 million patients between July 2010 and September 2012 in Florida and Georgia during which time about 7.7% of prescriptions were for opioids. At the outset, Florida’s monthly opioid volume and prescriptions dispensed were higher than Georgia’s. But the laws in Florida created statistically significant drops in the amount of opioids being prescribed and the volume in the state. 
 
A year after Florida’s laws took effect, opioid prescriptions dropped about 1.4%, opioid volume fell 2.4% and there was a 5.6% decrease in the morphine milligram equivalent per transaction. These reductions were highest among patients and prescribers with the highest baseline of opioid use and prescription. 
 
Subscribers to JAMA Internal Medicine can read the entire study here.
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Amneal launches generic Abilify liquid

BY David Salazar

BRIDGEWATER, N.J. — Amneal Pharmaveuticals has announced the launch of its liquid Abilify (aripiprazole) generic. The company is one of the first to launch a generic version of the discontinued Abilify Oral Solution used to treat depression, bipolar disorder and schizophrenia. 
 
“Healthcare providers can now continue prescribing a therapy they are comfortable with and in a form certain patients require,” Amneal EVP sales and marketing Jim Luce said. “It’s a product that would otherwise be unavailable if not for the generic equivalent.” 
 
As of June 2015, aripiprazole oral solution had annual U.S. sales of $62.8 million. Amneal’s liquid aripiprazole is currently shipping in 150-ml bottles direct to the trade and through distributors and wholesalers. 
 
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FDA approves Addyi, Sprout’s ‘female Viagra’

BY David Salazar

SILVER SPRING, Md. — The Food and Drug Administration handed down its anticipated approval of Sprout Pharmaceuticals’ Addyi (filbanserin 100 mg), a treatment for women with generalized hypoactive sexual desire disorder. The approval is the first for any drug addressing  sexual desire disorders, and the first HSDD, the most common form of female sexual dysfunction. 
 
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”
 
 
HSDD is characterized by persistent lack of sexual thoughts and responsiveness, as well as an unwillingness to engage in sexual activity that causes distress and can’t be explained by other conditions or substances
 
Addyi was approved with a Rish Evaluation and Mitigation Strategy (REMS) program, which will require certification for both pharmacists and providers. The drug is expected to hit the market on Oct. 17. 
 
“It has been a remarkable journey to get to this breakthrough moment. Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life impacting condition,” Sprout CEO Cindy Whitehead said. “We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence.”
 
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