NDA Green Lighted For Diazepam Buccal Film, Solanezumab and Gantenerumab Fail in Alzheimer Trial, Mind Moments Episode 7 Live

February 15, 2020

Neurology News Network for the week ending February 15, 2020.

This week Neurology News Network covered the NDA for Aquestive Therapeutics' diazepam buccal film for the treatment of seizure clusters, as well as the failed phase 2/3 trials of solanezumab and gantenerumab for patients with Alzheimer disease. Lastly, we detail the new NeurologyLive Mind Moments episode featuring Daniel M. Hartung, and his findings on rising costs in multiple sclerosis.

Marco: Welcome to Neurology News Network. I’m Marco Meglio. Let’s get into the news from this week.

The FDA has accepted a new drug application for Aquestive Therapeutics’ diazepam buccal film for the treatment of seizure clusters. The agency has declared a targeted PDUFA action date of September 27, 2020. Recently, in data presented at the 2019 American Epilepsy Society Annual Meeting, intermittent use of the therapy was shown to be safe, tolerable, and comparable to the rectal formulation of diazepam in the treatment of these seizures. In a statement, Keith J Kendall, CEO of Aquestive declared his and his company’s concerns about their formulation getting approval as the second-to-market variation of this therapy, though implied that the difference in delivery may be enough to overcome any negative effects on its chances of approval. He said that the company is looking forward to working with the FDA in that decision process, which he stated has “1 or more of the attributes required by the FDA to be considered a major contribution to patient care.”

Results from the Dominantly Inherited Alzheimer Network Trials Unit platform trial of solanezumab and gantenerumab showed that both drugs failed to reach the primary end point in patients with early-onset, inherited form of Alzheimer disease. The phase 2/3 double-blind, placebo-controlled, randomized study began as a 2-year biomarker target engagement study and evolved into a registration study that measured cognitive outcomes over a maximum 7-year follow-up period across 2 separate treatment arms. The trial used the unique DIAN Multivariate Cognitive Endpoint to measure cognitive performance in patients with autosomal-dominant AD. Additional data from the DIAN-TU study will be presented at the Advances in Alzheimer's and Parkinson's Therapies Focus Meeting in April 2020.

Episode 7 of the NeurologyLive Mind Moments podcast is now live! The episode, titled "No Relief: Rising MS Drug Prices," features an interview with Daniel M. Hartung, associate professor of pharmacy at Oregon State University College of Pharmacy, discusses findings of a report he and colleagues compiled on rising spending in the US Medicaid program on disease-modifying therapies for multiple sclerosis, and the unique nature of their prices in the United States. Hartung's research focus involves population-level assessments on the use of prescription drugs, the effect of drug policy on health outcomes, pharmacoepidemiology, and health economics.

For more direct access to expert insight, head to neurologylive.com. This has been Neurology News Network. Thanks for watching.