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Transcept Wins Approval for First Drug for Mid-Night Waking

Updated on

Transcept Pharmaceuticals Inc. won approval for the first drug designed to help people get back to sleep after waking in the middle of the night.

The Food and Drug Administration cleared Intermezzo, the drugmaker’s first product, the agency said in a statement today. The treatment contains a low-dose of zolpidem tartrate, the active ingredient in Paris-based Sanofi’s sleeping bill Ambien.

Transcept, based in Point Richmond, California, has a licensing agreement with Purdue Pharma LP that may generate $94 million in fees and royalties from Intermezzo, said Christopher James, a senior equity analyst at MLV & Co. in New York, in a Nov. 14 note.

“For people whose insomnia causes them to wake in middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking,” Robert Temple, deputy center director for clinical science in the FDA’s Center for Drug Evaluation and Research, said in the statement.

Transcept rose 11 percent to $7.34 at 4 p.m. New York time.

The company resubmitted its application Sept. 27 after the FDA told Transcept it was concerned about patients being too impaired to drive the day after use.

Transcept reduced the proposed Intermezzo dosing for women from 3.5 milligrams to 1.75 milligrams in the newest application and revised the instructions to take the drug only if patients have at least four hours of sleep remaining and to refrain from driving for at least one hour after waking, according to a company filing.

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