Sepracor files Lunivia MAA with EMEA

Massachusetts, USA-based Sepracor has submitted a Marketing Approval Application for Lunivia (eszopiclone) to the European Medicines Agency (EMEA) for review under the centralized procedure. This provides for a single, coordinated technical assessment that is conducted by the EMEA on behalf of all European Union member states, using experts from national authorities as lead reviewers. Eszopiclone, which is known in the USA as Lunesta, is indicated in that market for the treatment of insomnia. Approval of the MAA would authorize marketing of Lunivia in as many as 27 EU member countries.

Included in the MAA were results from 122 preclinical and 35 clinical studies. These studies involved more than 5,500 adult and older adult (>65 years of age) subjects, including patients with transient or chronic insomnia. In addition to the trials of Lunesta in patients with insomnia and co-existing conditions, two six-month, placebo-controlled evaluations in primary insomnia, as well as two driving studies that Sepracor believes will support a European labeling claim that Lunivia shows no effect on next-day driving (as measured by brake reaction time) in healthy subjects or subjects with insomnia, were included as part of the submission.

Sepracor has also commenced enrollment of its Pan-European six-month study of eszopiclone co-administered with Effexor X (venlafaxine HCl) in subjects with insomnia and co-existing Major Depressive Disorder. This 640-patient trial seeks to assess the potential benefit of eszopiclone in reduction of symptoms of depression and in relapse prevention.