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Clinical Development of Tecastemizole for the Treatment of Allergic Rhinitis Stopped
The U.S. Food and Drug Administration (FDA) issued a "not approvable" letter in March 2002 for Sepracor's New Drug Application (NDA) for SOLTARA for the treatment of allergic rhinitis. A "not approvable" letter is issued if the FDA believes that the application contains insufficient information for an approval action at that time.
Following a meeting with the FDA in the fourth quarter 2002, Sepracor initiated several preclinical and clinical studies. Contingent upon favorable results from these trials, Sepracor had intended to amend the SOLTARA NDA and seek marketing approval. Evaluation of the preliminary results from some of these preclinical and clinical trials indicates that the company would need to conduct additional studies, delaying the timing of a possible amendment to the NDA. After taking into consideration the results from recent tecastemizole trials, evaluating the changing dynamics of the U.S. antihistamine market, and thoroughly assessing the potential of all clinical candidates in Sepracor's portfolio, the company has decided to discontinue development of SOLTARA.
Source: Sepracor Inc.