FDA pins approval on new formulation of Ambien

To answer the question we raised in last week's issue of FierceDrugDelivery: Yes, the third time was a charm for Transcept ($TSPT) in its quest for FDA approval of its sleep drug. U.S. regulators gave a market green light to Intermezzo for treating middle-of-the-night waking on Nov. 23, providing the Point Richmond, CA-based developer with its first approved product. Intermezzo is a low-dose formulation of Ambien designed to dissolve and be quickly absorbed in the mouth.

Now the company faces the challenge of turning a reformulated generic drug into a commercial success in an already crowded insomnia market. Its commercial partner for Intermezzo, Purdue Pharma, has until Dec. 8 to decide whether to exercise its option to commercialize the drug, a right it paid an initial sum of $25 million for back in 2009. Transcend executives sounded hopeful that its partner would take the next step during a conference call on the afternoon of the big approval, but the ball is in Purdue's court.

After the FDA's previous safety concerns thwarted Transcept's two prior attempts to gain approval, an agency official made some glowing remarks about Intermezzo in the FDA's release last week.

"For people whose insomnia causes them to wake in [the] 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," stated Dr. Robert Temple, deputy center director for clinical science in the FDA's Center for Drug Evaluation and Research. "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."

- read more in FierceBiotech's article

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