Sepracor Soltara "not approvable"

FDA notifies Sepracor on March 6 that the NDA for Soltara (tecastemizole) 15 mg and 30 mg capsules will be found "not approvable." FDA is concerned about phospholipidosis and cardiomyopathy that was observed in animal studies of the antihistamine and wants further assurance "of the absence of any potential for QTc prolongation," Sepracor says. Because of Soltara's long terminal elimination phase, FDA believes safety evaluations were not of sufficient duration and also wants additional "evaluation of tissue concentrations of the drug after prolonged exposure…to quantify the potential for tecastemizole accumulation in target organs." Sepracor hopes to meet with FDA in two to four weeks to discuss what will be required for approval. The worst case scenario, the firm said in a March 7 teleconference, is that Sepracor will have to do a 90-day clinical study, which would take four to eight weeks to analyze and would be followed by a six-month FDA review. The firm is hoping instead to submit reanalysis of study data on 90 mg Soltara, which is three times the dose sought for approval. The NDA had a user fee goal of March 1