Upon publication of the final rule, Sepracor will commence full-scale commercial launch of Lunesta (eszopiclone). The company expects Lunesta to be widely available by prescription in pharmacies within days of publication and more than 40,000 retail pharmacies have already placed orders with wholesalers in anticipation of the launch.
“We are very excited about the commercial launch of Lunesta,” said W James O’Shea, president and COO at Sepracor. “Lunesta is the first and only sleep medication approved for long- term use, and we believe that, with its extensive clinical program that includes long-term studies, Lunesta will provide physicians with a unique treatment option for their insomnia patients.”
The FDA approved the new drug application (NDA) for Lunesta on December 15, 2004. Data from a landmark long-term safety and efficacy study formed part of the NDA submission and served as a basis for the FDA’s decision to approve Lunesta for long-term use. Sepracor’s six-month study was the first of its kind for a prescription non-benzodiazepine for the treatment of insomnia.