FDA experts recommend Merck sleep pill
pharmafile | May 24, 2013 | News story | Research and Development, Sales and Marketing | FDA, Merck, insomnia, suvorexant
Merck received welcome news this week from the FDA after one of the US regulator’s expert groups voted to approve the company’s insomnia drug suvorexant.
The Peripheral and Central Nervous System Drugs Advisory Committee’s verdict was 13-3 in favour of the first-in-class orexin receptor antagonist, and the FDA is likely – although not bound – to follow suit by authorising the drug.
“Today’s votes and discussion bring us one step closer to providing physicians with another option to help patients struggling with insomnia,” said Darryle Schoepp, senior vice president and head of neuroscience and ophthalmology, Merck Research Laboratories.
“We look forward to working with the FDA as the agency continues its review of our application,” he added. Merck anticipates a decision in ‘mid-year’.
Suvorexant works by blocking chemical messengers (orexins) from a key sleep centre in the brain which help keep people awake – but despite its novel action doctors may want more experience with the drug before prescribing it widely because there are so many alternatives.
Insomnia is a lucrative market, with Datamonitor predicting it could reach $7.7 billion in 2016 – but it is also highly competitive, with well-established treatments including Sanofi’s Stilnox/Ambien, Sepracor’s Lunesta, Takeda’s Rozerem and Pfizer’s Indiplon.
Data for suvorexant from a two-month discontinuation phase that followed a 12-month study were presented at the 21st Congress of the European Sleep Research Society last year, and built on previous positive results.
The trials looked at what happened when patients who had been taking suvorexant every night for a year were switched to placebo, replicating the period after patients stop taking a sleep medication.
Those who had been taking suvorexant for a year did see their insomnia return – but there was no sign of clinically meaningful withdrawal symptoms and rebound insomnia.
The two-month discontinuation phase showed that patients who switched from suvorexant to placebo took 14.9 minutes longer to fall asleep and slept 21.6 minutes less, compared to patients who continued taking suvorexant.
This level of their returned sleeping difficulties was similar to those of patients who had received placebo throughout the trial.
Patients who carried on receiving suvorexant for the additional two months experienced mean improvements in their ability to fall asleep and stay asleep – consistent with those seen over the first 12 months compared to placebo.
Merck says it wants to file in other countries as well as the US – not least because it hopes suvorexant will help shore up lost revenue after patent protection on its biggest-selling brand Singulair disappeared last year.
Adam Hill
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