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Biotech / Medical : Biotech failure, 2002
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To: Miljenko Zuanic who wrote (38)3/7/2002 8:25:54 PM
From: Miljenko Zuanic   of 130
 
Thursday March 7, 8:12 am Eastern Time
Press Release
SOURCE: Sepracor Inc.
Sepracor is Notified of Not-Approvable Action for SOLTARA(TM) Brand Tecastemizole
MARLBOROUGH, Mass., March 7 /PRNewswire-FirstCall/-- Sepracor Inc. (Nasdaq: SEPR - news) today announced that it was informed by the U.S. Food and Drug Administration (FDA) on March 6, 2002, that it intends to issue a ``not approvable'' letter for the New Drug Application (NDA) for SOLTARA(TM) brand tecastemizole 15 mg and 30 mg capsules. A ``not approvable'' letter is issued if the FDA believes that the application contains insufficient information for an approval action.

The FDA identified three issues that are not adequately addressed in light of certain aspects of the drug's pharmacokinetics and potential for accumulation in tissue. Two of the issues pertained to observations from safety studies in animals that were not observed in humans: phospholipidosis (an adaptive storage response to drug administration) and cardiomyopathy (a pathologic condition of the heart muscle). A third issue concerned the need for additional assurance of the absence of any potential for QTc prolongation (an effect on electrical impulse conduction in the heart).

It is Sepracor's interpretation of the FDA's concerns that, as a result of tecastemizole's long terminal elimination phase in both normal and cardiac- compromised patients, a review of the kinetic data in man suggests that Sepracor's safety evaluations were not of sufficient duration to provide adequate safety data at tissue steady-state. <snip>
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