FDA Rejects New Merck Sleeping Pill – For Time Being

FDA Rejects New Merck Sleeping Pill – For Time Being

July 2nd, 2013 // 3:01 pm @

Latest FDA and cGMP Compliance News

In a major set back for Merck, FDA has turned down a sleeping pill that Wall Street thinks will someday generate over $700 million in sales each year. FDA issued a response letter to Merck, which was published this week.

The major issue is the one of dosing, which was the major focus of an advisory committee meeting in May. FDA voted that the drug, called suvorexant, is safe at a lower does, such as 20 mg. But it is not safe at a dose of 30 or 40 mg. Merck states that the lower dose is not effective and is pushing for FDA to approve the higher doses.

FDA also stated its concern that the drug can cause you to be sleepy the next day and can even impair driving. It requested that the panel consider having patients start at the lower doses. Merck offered that most adults would begin at the 20 mg dose and boost it to 40 mg as needed. For older people, Merck said that they should start at 15 mg and then increase to 30 mg if needed.

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FDA states in its letter that the safety data does not show that the agency should approve the higher doses. But effectiveness for doses from 10-40 mg has been shown. FDA also noted that the dose of 10 mg should be where to start for the majority of patients, and should be made available before the drug can get approval. Also, 15-20mg doses would be the most appropriate in any patients who don’t find that a dose of 10 mg is effective.

After going over the letter, Merck noted that more clinical trials on the 10 mg dose is not needed. But, more manufacturing studies will be needed to advance the dosage form of 10 mg. Merck stated that it will talk with FDA on whether more studies are needed to support a dose of 5 mg. Merck did not state how long it will take to satisfy these new FDA requirements.

According to an industry analyst, forcing Merck to use lower doses and turning down the higher doses due to safety concerns, means that suvorexant will have rather mixed prospects in the market. FDA seems to be saying that it sees a safety issue with the sleeping pill, so it is going to make it a harder sell in the market, which already has a good deal of choice in this therapeutic area.

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