Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

Merck Gets Complete Response Letter From FDA For Suvorexant - Quick Facts

7/1/2013 8:31 AM ET

Merck & Co. Inc. (MRK: Quote) announced Monday that it has received a Complete Response Letter from the U.S. Food and Drug Administration or FDA regarding the New Drug Application for suvorexant, the company's investigational medicine for the treatment of insomnia. Insomnia is a condition characterized by difficulty falling asleep and/or staying asleep.

In the complete Response Letter, the FDA advised Merck that the efficacy of suvorexant has been established at doses of 10 mg to 40 mg in elderly and non-elderly adult patients; 10 mg should be the starting dose for most patients, and must be available before suvorexant can be approved.

The FDA also advised Merck that 15 mg and 20 mg doses would be appropriate in patients in whom the 10 mg dose is well-tolerated but not effective; and, for patients taking concomitant moderate CYP3A4 inhibitors, a 5 mg dose would be necessary.

In addition, the FDA determined that the safety data do not support the approval of suvorexant 30 mg and 40 mg.

"We will evaluate the requests outlined in the Complete Response Letter, and expect thereafter to work expeditiously with the FDA to make suvorexant available as a new treatment option for patients suffering from insomnia," said Roger Perlmutter, president, Merck Research Laboratories.

The company said based on initial review of the letter, it has determined that additional clinical studies of suvorexant 10 mg will not be necessary. However, manufacturing studies will be required to advance the 10 mg dosage form. The company said it will discuss with the FDA whether additional studies will be required to support the 5 mg dose.

Register
To receive FREE breaking news email alerts for Merck & Co Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
While Republicans will try to use the troubled rollout of Obamacare to their advantage in the upcoming midterm elections, the results of a Reuters/Ipsos poll showed that Americans increasingly think Democrats have a better plan for healthcare. Nearly three hundred people are still unaccounted for after a ferry carrying 462 people capsized and sank off South Korea's southern coast, media reports citing local officials said Wednesday. The ill-fated ferry, carrying mostly high school students on an overnight trip, was heading to the tourist island of Jeju from the city of Incheon, a northwestern South Korean city that houses the country's After moving mostly higher in early trading on Wednesday, stocks have continued to perform well over the course of the session. While buying interest has waned since then open, the markets have maintained a positive bias on the day.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.