(Reuters) - Transcept Pharmaceuticals Inc said the U.S. health regulator has approved its sleep drug Intermezzo as a first-of-its kind treatment of a particular type of insomnia.
The approval — after two rejections earlier — comes four days before the review date originally assigned by the U.S. Food and Drug Administration for the drug.
Intermezzo, chemically known as zolpidem tartrate sublingual, can now be used as a therapy for insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.
Transcept said the drug is a lower dose formulation of zolpidem tartrate, which was approved by FDA in 1992 for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
“With this lower dose, there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving,” Robert Temple, M.D., deputy center director for clinical science in the FDA’s Center for Drug Evaluation and Research, said.
Transcept said the recommended and maximum dose of Intermezzo is 1.75 milligrams for women and 3.5 mg for men, taken once per night.
Shares have lost about a quarter of their value since July, when the company said it expected the FDA would reject its Intermezzo application the second time.
On Wednesday, the stock was trading marginally up at $6.69 before being halted at 12:57 ET
Reporting by Zeba Siddiqui in Bangalore; Editing by Joyjeet Das