FDA agrees to review Merck's Suvorexant for sleeplessness

The US FDA have accepted the New Drug Application (NDA) for suvorexant, Merck's investigational insomnia medicine. Suvorexant will be evaluated by the Controlled Substance Staff of the FDA during NDA review. If approved by the FDA, suvorexant will become available after a schedule assessment and determination has been completed by the U.S. Drug Enforcement Administration, which routinely occurs after FDA approval.

The NDA for suvorexant was based on data from a broad clinical development program, including: two pivotal, three-month efficacy trials that evaluated the ability of suvorexant to help patients fall asleep and stay asleep; a 12-month study, followed by a two-month discontinuation phase, that was designed to assess the safety of suvorexant, while also evaluating its longer term efficacy and the impact of stopping treatment; and two next-day driving studies that provided an assessment of residual effects following evening use of suvorexant.

Merck researchers developed suvorexant to target and block orexins, chemical messengers that help to keep you awake. By temporarily blocking the actions of orexins, suvorexant helps to facilitate sleep. If approved, suvorexant would be the first in a new class of medicines, called orexin receptor antagonists, for use in patients with difficulty falling or staying asleep

Are Pharma Companies increasing the number of Voluntarily initiated Phase IV trials

The study, “Phase IV Clinical Trials: Best Practices in Post-Marketing Study Management,” conducted by Cutting Edge Information found that 82% of surveyed companies’ post-marketing trials are voluntarily initiated. That percentage is an increase from 61% of Phase IV trials that were voluntarily initiated by drug manufacturers in 2006.

I took a quick look at the number of phase IV trials at the ClinicalTrials.gov registry and surprised to see that the number of Phase IV trials disclosed by Pharmaceutical companies was on a decline. Is the disclosure limited to trials that are conducted as part of Life Cycle Managment of the drugs or are the companies conducting trials purely for commercial reasons and do not have an obligation to report those.

Here is what ClinicalTrials.gov reflects on the phase IV trials run by pharmaceutical companies.