Med Check

The National Institute on Drug Abuse (NIDA) has entered into a partnership with the pharmaceutical company Lightlake Therapeutics to develop intranasal naloxone as a method for treating drug overdose. Naloxone, an injectable medication initially developed and tested by Lightlake to treat binge-eating disorder, can rapidly reverse overdose of prescription and illicit opioids.

The NIDA-sponsored clinical trial will begin this fall by evaluating the pharmacokinetic properties of intranasal application in 14 healthy volunteer subjects. The goal of the partnership is to bring to market within 12 to 18 months a Food and Drug Administration (FDA)–approved intranasal naloxone solution that can reverse opioid overdoses.

“Naloxone is a lifesaving drug [that has] proven to be very safe and has been used for decades,” said Lightlake CEO Roger Crystal. “The problem is that it’s not readily available and only approved for administration through injection. We are working with NIDA to create an intranasal delivery system that can make naloxone much easier to use and more accessible for first responders, paramedics, and families and friends of addicts who are at risk of overdose.”

Use of medication to treat psychiatric illnesses in children aged 2 to 5 decreased approximately 50 percent overall from 1994 to 2009, but increased among boys, Caucasian children, and those without private health insurance, according to a study published in Pediatrics.

“The likelihood of receiving a behavioral diagnosis increased [from] 2006 to 2009, but this was not accompanied by an increased propensity toward psychotropic prescription,” said Tanya Froehlich, M.D., senior author and a pediatrician at Cincinnati Children’s Hospital Medical Center.

Froehlich speculated that the overall decrease in psychotropic drug use in young children is likely due to the numerous warnings—including increased risk for suicidal ideation with amphetamines and cardiovascular events with psychostimulants—issued by the FDA in the last decade. She said that additional research is needed to determine why certain populations are more likely to receive these medications and investigate the long-term developmental effects of psychotropic medication use in young children.

 Chirdkiatgumchai V, Xiao H, Fredstrom B, et al. “National Trends in Psychotropic Medication Use in Young Children: 1994-2009.” 2013. Pediatrics. Oct;132(4):615-623. http://pediatrics.aappublications.org/content/132/4/615.long.

In response to the September 23 modification of the Health Insurance Portability and Accountability Act (HIPAA) that is designed to limit marketing of personal medical information, InVentiv Health has filed suit against the Department of Health and Human Services claiming that the rule eradicates the firm’s prescription refill reminder program—resulting in violations of the company’s free-speech rights.

“This rule undermines a valuable extension of a physician’s treatment that promotes patient health, helps save lives, and reduces health care costs, [and is] consistent with the objectives of the Affordable Care Act,” said InVentiv Health’s general counsel Eric Sherbet. The change, he added, “impinges on our right to speech that serves a significant public-health interest.”

Last year, 71 percent of pharmaceutical companies reported putting more effort towards patient-adherence programs—costing them an average of $1.53 million, up 281 percent from 2009, according to the Cutting Edge marketing firm.

“Attempts to restrict speech are subject to ‘heightened scrutiny’ and must be shown to advance a substantial government interest….The new rule fails to pass such scrutiny and does not advance any government interest. On the contrary, the government’s interest is in improving public health while keeping down costs—and refill reminders further these interests,” said InVentiv in a statement.

Three months after Maine passed legislation to allow its citizens to purchase prescriptions through mail-order pharmacies based outside the United States, the state is facing a lawsuit by pharmaceutical trade groups and state pharmacists and retailers for circumventing federal regulations concerning prescription drugs.

“Prescription drugs shipped to Maine by foreign pharmacies…are not subject to any of the quality and safety controls put in place by the federal government in order to protect persons who rely on prescription medications,” according to the lawsuit. The complaint also argues that the FDA has “consistently warned” state governments not to import drugs from other countries.

According to reports from Maine state workers and the city of Portland, purchasing medicines through Canadian mail-order pharmacies saved them $10 million in previous years—but these savings ended after a former state attorney general banned such practices in August 2012.

The new law—implemented October 9—to reopen trade with foreign pharmacies was heavily supported by state and local governments, as well as some member of the business community. The Maine state employees union has estimated savings of $6 million to $10 million from the ability to buy medications through overseas mail-order pharmacies, according to state Sen. Troy Jackson, who introduced bill.

A randomized controlled study published in BMC Psychiatry investigated the rate of hallucinations in 226 adult patients with psychosis and compared the antihallucinatory effectiveness of the antipsychotic drugs risperidone, ziprasidone, and quetiapine. Hallucinations were measure by the hallucinatory behavior item of the Positive and Negative Syndrome Scale.

Sixty-eight percent of the patients were hallucinating at baseline. After six weeks of treatment with antipsychotic medications, overall hallucinating rates decreased to 33 percent. Patients administered quetiapine or ziprasidone were found to have lower rates of hallucinations than those taking risperidone.

The study noted that “Hallucinations are fairly responsive to antipsychotic drug treatment, and differential antihallucinatory effectiveness may be found among existing antipsychotic drugs. If replicated, this could pave the way for a more-targeted pharmacotherapy based on individual symptom profiles, rather than on the diagnostic category.”

Johnsen E, Sinkevicute I, Løberg E, et al. “Hallucinations in Acutely Admitted Patients With Psychosis, and Effectiveness of Risperidone, Olanzapine, Quetiapine, and Ziprasidone: A Pragmatic, Randomized Study.” 2013. BMC Psychiatry. Sep 30. [Epub ahead of print]. http://www.biomedcentral.com/1471-244X/13/241. ■