Merck releases new Phase III insomnia data
pharmafile | September 11, 2012 | News story | Research and Development, Sales and Marketing | Merck, insomnia, suvorexant
Merck says it is on course to file its investigational insomnia drug suvorexant in the US by the end of this year after releasing new Phase III data.
Suvorexant would be the first in a new class called orexin receptor antagonists, blocking chemical messengers (orexins) from a key sleep centre in the brain which help keep people awake.
Insomnia is a lucrative market, with Datamonitor predicting it could reach $7.7 billion in 2016 – but it is also highly competitive.
While Merck believes suvorexant offers a new way of tackling sleep disorders, the sheer number of alternatives available means health professionals may want more experience with the drug before prescribing it widely.
Treatments such as Sanofi’s Stilnox/Ambien, Sepracor’s Lunesta, Takeda’s Rozerem and Pfizer’s Indiplon are well-established in this therapy area.
Merck says that suvorexant will be evaluated by the controlled substance staff of the F DA.
New results – building on earlier positive data – from a two-month discontinuation phase that followed a 12-month study were presented at the 21st Congress of the European Sleep Research Society.
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.
Darryle Schoepp, head of the neuroscience and ophthalmology franchise at Merck Research Laboratories, said the results offered “important insights into suvorexant and the chronic nature of insomnia”.
As well as the US, Merck says it wants to file in other countries – not least because it hopes suvorexant will help shore up lost revenue after patent protection on its biggest-selling brand Singulair disappeared last month.
Adam Hill
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