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Setback for Merck & Co as FDA knocks back insomnia drug

US regulator asks for company to file for approval of a lower starting dose of suvorexant

Merck and Co - US headquartersThe US Food and Drug Administration (FDA) yesterday said it will not approve Merck & Co's insomnia drug suvorexant unless the company files for approval of a lower starting dose.

In a complete response letter (CRL), the regulator said Merck will have to seek approval for a 10mg starting dose for suvorexant before it can consider approval, because of safety concerns at higher doses.

Merck said it does not expect to have to carry out any additional trials of suvorexant before approval, but it will have to conduct manufacturing studies to bring the lower dose forward.

The FDA's verdict ties in with the conclusions of its advisory committee, which voted last month that suvorexant was safe and effective at doses above 10mg per day, but had reservations about its safety at 30mg and 40mg doses.

Merck had been seeking approval for starting doses of 15mg or 20mg, depending on the age of the person taking it, with an option to increase the dose to 30mg to 40mg if the lower doses were not effective.

The FDA wants patients to start on 10mg - or 5mg for patients taking certain concomitant medications - with the possibility of raising it to 15mg or 20mg if the lower dose is ineffective. It says safety data do not support the approval of the 30mg and 40mg doses.

Suvorexant is the first drug in a new class of insomnia medicines called orexin receptor antagonists to reach the regulatory stage, and is one of the most anticipated drugs in Merck's late-stage pipeline.

The company's hope is that it can position suvorexant as a sleeping medicine that can avoid the side effects of current therapies, such as next-day drowsiness and dependency. Analysts have suggested that sales could reach $500m within three years of launch and more than $1bn at peak.

Merck's recently appointed R&D chief Roger Perlmutter said the firm would "evaluate the requests outlined in the CRL, and expect thereafter to work expeditiously with the FDA to make suvorexant available as a new treatment option for patients suffering from insomnia."

2nd July 2013

From: Research, Sales, Regulatory

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