Transcept Pharma battles to get FDA nod for sleep drug

Transcept's ($TSPT) third run at an approval of its sleep drug ended in victory Wednesday. The FDA has stamped an approval on the company's drug Intermezzo, which is a low-dose formulation of zolpidem tartrate (Ambien) that is intended to help people fall asleep after they wake up in the middle of the night. Intermezzo is the Point Richmond, CA-based developer's first approved product, and the FDA says that the drug is the first treatment to get a market green light for middle-of-the-night waking.

The company whiffed in its previous two attempts to gain approval of the drug. In the most recent denial this summer, U.S. regulators cited concerns about the safety risks to patients who get behind the wheel of a car after taking the drug. To address safety concerns, the developer worked out a dosing strategy for the drug with regulators in its latest application for approval. The company has won approval of the drug at a 1.75 mg recommended dosage for women and 3.5 mg for men, and the gender-specific dosages are due to women's slower metabolism of zolpidem tartrate. The approval also recommends that the drug not be taken if the patient has fewer than four hours before he or she expects to wake up.

Purdue Pharma has rights to commercialize the drug in the U.S. Transcept, which collected $25 million upfront in its partnership deal struck in 2009 with Purdue, lost out on $30 million in additional payments from Purdue tied to the pact because of the delay in getting the approval. Now with the market green light, Transcept stands to gain the lion's share of money in the deal. However, the big question now is whether Purdue will pick up its option to commercialize Intermezzo in the U.S., a decision that Purdue has until Dec. 8 to make.

The FDA has been tough on the safety risks of new sleep medicines, and Transcept has certainly shown some tenacity en route to this approval. Today, an agency official made an upbeat statement about the safety benefits of the new treatment option.

"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."

Intermezzo is a sublingual tablet that is designed to be rapidly absorbed in the mouth and into a patient's system to help them fall asleep quickly, as has been shown in clinical studies. That differentiates the drug from generic Ambien, which was approved in 1992, but the sleep drug market is crowded with competing therapies.

Still, Transcept CEO Glenn Oclassen and his team showed grit to get through a rigorous FDA review process with an approval in hand, something that might merit recognition regardless of whether the drug ends up being a commercial hit.

- here's the FDA release
- see Reuters' coverage

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