Transcept resubmits sleep drug

Transcept Pharmaceuticals has resubmitted the US new drug application for Intermezzo (zolpidem tartrate), a treatment of insomnia characterised by difficulty returning to sleep after middle of the night awakening. If approved, the sublingual tablet will be the first drug cleared in the US specifically for that usage and will be marketed by Purdue Pharma.

The resubmission responds to issues raised in a complete response letter issued by the US Food and Drug Administration (FDA) in late 2009. If the resubmission is accepted as complete by the FDA, Transcept anticipates a six-month review for the drug.

The new application package includes data from a highway driving study and redesigned product packaging and instructional tools, as well as other new information.  The resubmitted application also includes a recent epidemiology study showing that sleep aids approved for bedtime dosing are frequently used by consumers in the middle of the night although they are not cleared for that use.

"We plan to work closely with the FDA through the resubmission process and are fully committed to making this important therapeutic option available to insomnia patients," Transcept CEO Glenn A Oclassen said in a statement.

Purdue licensed US rights to Intermezzo through an August 2009 deal that could be worth up to $145m to Transcept if certain milestones are met. The drug is a low-dose version of sanofi-aventis' Ambien.