The Food and Drug Administration (FDA) has recommended that health care professionals who prescribe the sleep medication eszopliclone (Lunesta) use a lower starting dose than is often the case due to risk of impairment the morning after its use. The recommended starting dose has been decreased from 2 mg to 1 mg.
The dose change is based in part on findings from a study of nearly 100 healthy volunteers, aged 25 to 40, who were given 3 mg of eszopliclone or placebo. The data showed that administration of 3 mg of eszoplicone was associated with severe next-morning memory and psychomotor impairment—which included driving skills—in both men and women up to 11 hours after taking the drug. According to the study, despite the long-lasting effects, patients were often unaware that they were impaired.
The FDA recommends that patients currently taking 2 mg or 3 mg doses of eszoplicone contact their physician to ask for instructions on how to continue to take their medicine safely at a dose that is best for them.
“Recently, data from clinical trials and other types of studies have become available, which allowed the FDA to better characterize the risk of next-morning impairment with sleep drugs,” commented Ellis Unger, M.D., director of the Office of Drug Evaluation I at the FDA. “To help ensure patient safety, health care professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia.”
In June, the Austrian pharmaceutical company AFFiRiS said its new drug AD04—a peptide-derived vaccine targeting amyloid-beta—is the first “to demonstrate clinical and biomarker effects consistent with disease modification” of Alzheimer’s disease (AD).
The claim is based on results from a phase 2 clinical trial of 332 patients with early AD who were administered AD04. After 18 months, the analysis showed that 47 percent of the patients achieved stabilization or improvement in cognitive function, as assessed by the Neuropsychiatric Inventory. The company also found that treatment with the plaque-dissolving vaccine was associated with a less-severe decline in the volume of the hippocampus—a region of the brain that has been seen to shrink during the early stages of dementia.
The company’s chief medical director, Achim Schneeberger, M.D., said, “Because the current results are so extremely positive and consistent across clinical outcomes and brain volumes, we expect to verify them in further clinical investigations.”
The injectable form of naltrexone intended for substance use disorder (SUD) may be more effective—based on patients’ adherence and overall cost—than oral medications, according to researchers from the College of Pharmacy at Oregon State University.
“Historically, oral medications for substance abuse have not often been . . . found to have a high degree of success, mostly because patients stopped taking them,” Daniel Hartung, Pharm.D., M.P.H., an associate professor and lead author, commented. “With more people having access to medications [intended for SUD treatment], now would be a good time to do further research on the comparative efficacy and use of them.”
Hartung and colleagues performed a meta-analysis to compare overall cost and utilization outcomes between injectable naltrexone and other pharmacotherapies in nearly 62,000 patients with either alcohol or opioid dependence.
The results showed that alcohol-dependent patients taking the injectable version of naltrexone were more likely, within a six-month period, to refill their medication than those taking acamprosate or oral naltrexone.
As it relates to opioid dependence, patients who were administered extended-release naltrexone had lower inpatient utilization rates for substance abuse than those who received other pharmacotherapies. Total cost for the once-a-month version of naltrexone intended for opioid dependence was found to be $8,170 cheaper than methadone.
The authors noted that the current findings offer support for a wider use of medications that may help reduce or prevent substance abuse and related hospital admissions. “The cost savings could offset the cost of the medication, . . . [particularly] in the advancing era of health care reform,” the researchers concluded. The study was funded by Alkermes, a manufacturer of naltrexone.
The FDA, in partnership with other federal and international agencies, took action against websites that sell potentially harmful, unapproved prescription drugs to U.S. consumers.
“When consumers buy prescription drugs from outside the legitimate supply chain, they cannot know if the medicines they receive are counterfeit or even if they contain the right active ingredient in the proper dosages,” said Douglas Stearn, J.D., director of the FDA’s Office of Enforcement and Import Operations. “Consumers have little or no legal recourse if they experience a reaction to the unregulated medication or if they receive no therapeutic benefit at all.”
Actions against the online illegal pharmacies were implemented in conjunction with the Seventh Annual International Internet Week of Action at which law enforcement, customs, and regulatory authorities from 111 countries came together to identify drug manufacturers and distributors who were selling unapproved medicines and medical devices via the Internet. Nearly 2,000 violators were identified.
Taking the investigation a step further, the FDA, along with the U.S. Customs and Border Protection, conducted an extensive examination of packages located at U.S.-based international mail facilities in New York, Los Angeles, and Chicago and seized 583 packages of unapproved drug products— from countries including China, Mexico, Australia, and the United Kingdom—that were en route to U.S. consumers.
Philip Walsky, acting director of the FDA Office of Criminal Investigations, said, “The FDA will continue to leverage our resources and strengthen our national and international partnerships to shed light on these Internet-based fraudulent activities that target consumers.” ■