On September 14, 2011, Shares of Transcept Pharmaceuticals, Inc. (NASDAQ:TSPT) jumped more than 18% in its after hour trading following the announcement made to resubmit its Intermezzo New Drug Application (NDA) for insomnia treatment after a meeting with the U.S. Food and Drug Administration (FDA).
Yesterday, the company announced its plans to resubmit its NDA for Intermezzo, a drug to be used for treatment of insomnia which is a disease in which people finds it difficult to sleep after waking up in the middle of the night. Considering the safety concern, FDA rejected the drug in July, but in yesterday’s meeting it agreed with the company’s proposal to reduce the recommended Intermezzo® dose for women from 3.5 mg to 1.75 mg, and to keep the recommended Intermezzo® dose for men at 3.5 mg. TSPT also added a new instruction stating that drug should only be taken if patients have at least 4 hours of bedtime remaining and he should not drive for at least 5 hours after dosing Intermezzo.
Following the meeting with FDA, the company has planned to resubmit the Intermezzo NDA by the end of this September without undertaking any further studies on it. FDA said that it could review the new application in as little as two months.
The stock closed at $3.34, up 34 cents or 11.33% from its previous close of $3.00. Volume of 0.684 million shares has been traded, above the daily average of 0.154 million shares. The 52 week range of the stock is $2.58-$11.88. The market cap of the stock stands at $45.17 million with beta of 2.36.
Transcept Pharmaceuticals, Inc., formerly Novacea, Inc., is a specialty pharmaceutical company focused on the development and commercialization of products that address important therapeutic needs in neuroscience. The Company’s most advanced product candidate, Intermezzo (zolpidem tartrate sublingual tablet), is a sublingual low dose formulation of zolpidem that it is developing for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep.
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