Shares of Transcept Pharmaceuticals ($TSPT) shot up more than 70% after the biotech laid out plans to resubmit its sleep drug Intermezzo to the FDA--after the agency green-lighted its plan to adjust dosing based on gender and fine-tune the timing instructions on the label.
Transcept was handed a rejection on Intermezzo a few months ago after regulators raised a red flag that the drug--a reformulated, sublingual version of Ambien (zolpidem tartrate)--could be unsafe for some patients who used it in the middle of the night. The agency felt that any residual levels of the drug could interfere with driving--a key safety hurdle for many new insomnia treatments.
The biotech's response was to agree to reduce the dosing level for women--from 3.5 mg to 1.75 mg--keep the same dose for men and add to the amount of time a person would need to wait before getting behind the wheel after taking a dose. And the FDA's approach, Transcept added, would allow the biotech to resubmit the app this month without additional trials and with the prospect of a two-month review.
That formula seemed just right for some of the company's backers, who started pushing up the stock price in after-hours trading.
- check out the Transcept release
- read the story from the Wall Street Journal