Med Check

Avanir Pharmaceuticals recently announced positive results from its phase 2 clinical trials examining the safety and efficacy of AVP-923 for treatment of agitation in patients with Alzheimer’s disease (AD).

“This is an exciting advancement in Alzheimer’s disease research,” said Jeffrey Cummings, M.D., director of the Cleveland Clinic Lou Ruvo Center for Brain Health and chair of the study’s steering committee. “Dementia-related neuropsychiatric symptoms such as agitation are extremely distressing to patients and their families.”

The study was a 10-week, double-blind trial with 220 patients with AD who were given either AVP-923 or placebo. The analysis showed that usage of AVP-923 was significantly associated with reduced agitation, measured by the Neuropsychiatric Inventory, when compared with placebo. It was also associated with a reduction of scores on scales measuring caregiver burden. The most common side effects reported were falls, diarrhea, and urinary tract infection—occurring in less than 10 percent of the patients taking AVP-923.

AVP-923 key components are dextromethorphan, a commonly used ingredient in cough medicines, and quinidine, used to control irregular heartbeats.

Dominion Diagnostics, a provider of drug testing and medication monitoring, is marketing a laboratory-based urine test for the detection of Z-drugs— nonbenzodiazepine-derived medications used to treat insomnia .

Z-drugs, promoted as “benzodiapine-like” drugs with fewer potential side effects such as residual daytime sedation and rebound insomnia, have become popular among recreational users—with zolpidem (a Z-drug and the key ingredient in Ambien) accounting for 11.5 percent of all emergency department visits made by adults aged 18 and older for adverse events related to psychiatric medicines, according to the Centers for Disease Control and Prevention.

Dominion’s testing for Z-drugs uses a system of ultra-performance liquid chromatography and tandem mass spectrometry to detect the metabolites of commonly prescribed nonbenzodiazepines, including zolpidem, eszopiclone , and zaleplon .

“Z-Drugs are chemically distinct from benzodiazepine medications and will not be detected in a benzodiazepines screening test or confirmatory procedure,” said Lawrence Andrade, manager of research and development at Dominion.

Janssen Pharmaceuticals has released results of its study involving the Janssen Connect program, which is designed to increase adherence to antipsychotic regimens in patients with schizophrenia. The results were presented at the U.S. Psychiatric and Mental Health Congress in September.

The study involved 9,354 individuals with schizophrenia who were prescribed Janssen’s Invega Sustenna (paliperidone palmitate) , an injectable, long-acting antipsychotic, and enrolled in Janssen Connect from December 2010 to April 2014. Participants could receive the injections at an “injection center,” typically a pharmacy, in lieu of going to a health care practice.

The results showed that those opting for the injections were 4.5 times more likely to adhere to their medication than those who chose not to receive injections at the centers. Patients were considered to be adherent if they were administered their medication at least 80 percent of the time during the study.

“These results are proof that we’re moving in the right direction,” said Catherine Piech, vice president of health economics and outcomes research at Janssen Scientific. “[This] program was born out of our dedication to helping people living with schizophrenia navigate through the difficulties … [associated with] staying on medication as prescribed by their health care provider.”

Pharmaceutical giants AstraZeneca and Eli Lilly are joining forces to commercialize and further develop AZD3293 , an oral beta secretase cleaving enzyme (BACE) inhibitor, as a potential treatment for Alzheimer’s disease (AD). The newly developed pharmacoagent, which functions to prevent amyloid plaque formation, is currently in early-stage testing.

“We are looking forward to working with Lilly, an organization with a long-term commitment to and expertise in treating Alzheimer’s disease,” said Mene Pangalos, an executive vice president at AstraZeneca. “By combining the scientific expertise from our two organizations and … sharing the risks and cost of late-stage development, we will be able to accelerate the advancement of … a promising new approach” to treating AD.

Under the agreement, Lilly will pay AstraZeneca up to $500 million in development and regulatory milestone payments—with the first milestone payment of $50 million to be received in 2015. The companies will share all future developmental costs, as well as global revenue, equally.

The companies plan to rapidly move AZD3293 into phase 2 and phase 3 trials in patients with early AD.

Neuronetics Inc. conducted the largest study to date on long-term effectiveness of its NeuroStar TMS Therapy (NSTT) in adults with major depressive disorder who have failed to benefit from treatment with antidepressant medication. NSTT is a by-prescription transcranial magnetic therapy that regulates mood via a nonsystematic (that is, independent of the circulatory system) and noninvasive approach. It is administered in the office five days a week for four to six weeks.

The study, published in the Journal of Clinical Psychiatry, showed that at the end of acute treatment (four to six weeks) with NSTT in 257 patients, 62 percent achieved symptomatic improvement, while 41 percent reported complete remission. These results were maintained after one year, with 68 percent achieving symptomatic improvement and 45 percent reporting remission. The most common side effect reported was pain or discomfort at or near the treatment site.

Neuronetics is studying the effectiveness of NSTT in patients with postpartum depression. ■