Big Pharma (Merck) Gets Rejected by FDA

The financial stakes are high in the insomnia medication market, but officials at Merck & Co will have to revamp their latest offering to suit regulators. Health officials at the FDA rejected the latest insomnia drug application from the New Jersey-based giant, but reportedly opened the door to approving a lower-dose version of the medication.

A recent announcement confirmed that the FDA would consider a 10-mg starting dose of suvorexant for most patients. Merck, however, had maintained lower dosing, which had not been studied in clinical trials, was less effective and was pushing for agency approval of the higher doses.

Merck had proposed that elderly patients start by taking 15 mg of the drug and increase that to 30 if necessary, and had recommended that non-elderly adults start on 20 mg and increase to 40 mg if needed. In its letter, the FDA determined that doses of 30 mg and 40 mg were not safe for approval, Merck said last week.

ISI Group analyst Mark Schoenebaum forecasted annual suvorexant sales of $700 million by 2018, and estimated a modest impact to Merck from the delay.

Schoenebaum said the manufacturing study could lead to about a one-year delay in approval, especially if the FDA asks for long-term stability testing of the lower dose version.

Suvorexant belongs to a new class of insomnia medicines called orexin receptor antagonists and would be the first such medicine on the market if approved. It is designed to facilitate sleep by blocking neurotransmitters in the brain that help to keep a person awake.

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