Sepracor says it will not be launching its sleep drug, Lunesta (eszopiclone), as soon as it had planned, because the US Food and Drug Administration has recommended the product be classed as a schedule IV controlled substance – a process which has not yet been completed.
The company’s shares took a knocking on the news, after it said that because of uncertainties regarding marketing the product before scheduling is completed, plans to make Lunesta available in early January 2005 are no longer feasible. However, the firm’s share price rallied after it said it still hoped to launch Lunesta during the first quarter of the year. Sepracor says it is working with the FDA to resolve the uncertainties and conclude final administrative actions related to the drug’s scheduling. “All commercial activities, including manufacturing, supply chain and sales and marketing required for a successful launch, are firmly in place,” W. James O’Shea, Sepracor’s president and chief operating officer, noted.
Lunesta – formerly known as Estorra – won FDA approval late in 2004, based on data from a six-month 788-patient trial [[17/12/04d]].