Med Check

Ketamine Effects Sustained Over Two Months

Another small-scale clinical trial for ketamine has catapulted the drug back into headlines of some major news outlets, suggesting that the effectiveness of the NMDA-receptor antagonist can be sustained with help from other pharmacoagents.

Researchers from Columbia University administered various doses of lurasidone, olanzapine/fluoxetine, or quetiapine to eight patients with treatment-resistant bipolar depression for one month before infusing the patients with a one-time dose of ketamine (0.5 mg/kg) for 60 minutes, immediately followed by 300 to 1,000 mg daily doses of the tuberculosis drug D-cyclosporine, another NMDA antagonist, for eight weeks.

The researchers observed a 50 percent reduction in depression and a 75 percent reduction in suicidality among participants over one to two weeks, which is not unusual when ketamine is administered alone or with FDA-approved antipsychotics for bipolar depression. What was unique, the researchers noted, was that these effects lasted up to two months in the presence of D-cyclosporine.

While the authors of the study noted more studies are needed to assess D-cycloserine’s independent efficacy and safety in bipolar depression, the study received much praise from NeuroRX, a small biotech company that is developing a ketamine/lurasidone/D-cyclosporine combo treatment for bipolar depression. The company was not involved with this study.

According to a statement released by NeuroRX, “This is the first clinical report showing that the ketamine effect can potentially be sustained for two months with additional agents.”

Pristiq Fails in Pediatric Trials

Pfizer’s Pristiq ER was recently found to be no more effective in children than placebo, according to the company. This selective serotonin and norepinephrine reuptake inhibitor (SNRI) received approval by the FDA in 2008 for the treatment of major depressive disorder in adults.

The phase 3 trial, which involved 340 youth aged 7 to 17 with major depressive disorder, was the first of four phase 3 pediatric trials being conducted as part of an FDA postmarketing commitment under the Pediatric Research Equity Act, which requires pharmaceutical companies to conduct pediatric studies with recently approved drugs for the same use for which those drugs were approved in adults.

Lundbeck and Otsuku Set to Launch New Antipsychotic

In July, the FDA approved the Lundbeck and Otsuku co-developed drug Rexulti (brexpiprazole), which is intended to treat schizophrenia and major depressive disorder. The drug is a dopamine D2 and serotonin 5-HT1A partial agonist.

The effectiveness of the new compound was shown in a multisite international study published April 17 in AJP in Advance. In the study, patients administered 2 mg and 4 mg of brexpiprazole for six weeks had significantly lower scores on the Positive and Negative Syndrome Scale than those who took placebo, with no clinically significant changes in baseline lipid and glucose levels and extrapyramidal symptom ratings (Psychiatric News, May 15, 2015).

In a press statement, Lundbeck noted that in most trials concerning Rexulti, more than 90 percent of participants completed treatment protocols, making the drug one of the “best-in-class” for tolerability. The company expects that the drug could be on the market as soon as the end of this month.

Adults Take More ADHD Meds Than Children

Children are no longer the prime market for medicines used to treat attention-deficit/hyperactivity disorder (ADHD) in the United States, according to a recent report by Shire Pharmaceuticals.

According to Shire, which manufactures the top-selling ADHD medication Vyvanse (lisdexamfetamine), compiled data from a national database on prescription drugs revealed that 53 percent of prescriptions for ADHD medications in 2014 (63 million prescriptions) were for adults, up from 39 percent in 2007. Children aged 6 to 17 accounted for 47 percent of such prescriptions in 2014, down from 61 percent in 2007.

A report in Bloomberg suggests the market shift may be due to growing evidence that the disorder can persist into adulthood and findings that show that more parents of children with ADHD are being diagnosed with the condition amid the growing awareness that ADHD can be inherited.

During a conference call with analysts, Shire’s CEO Flemming Ornskov said that the company “has shifted more efforts into the adult ADHD market” and will be directing sales representatives to spend more time telling physicians about studies concerning adult use of ADHD medications. ■