Stedesa’s FDA Decision Anticipated Soon (NASDAQ:SEPR)

Stedesa is a drug that has been developed by Sepracor Inc. (NASDAQ:SEPR). The company has already submitted the application – known as the New Drug Application (NDA) – for the approval of the United States of America’s Food & Drug Administration to market Stedesa. The application as submitted on March 31, 2009. As per the law of Prescription Drug User Fee Act, the FDA had to notify the company within 60 days (that is, by May 30) about whether it had accepted the application for filing. And so after a long wait of 60 days, on June 02, 2009, the company announced that the US’s toughest regulator FDA had accepted the New Drug Application for filing. This means the NDA has passed the first stage of the approval process – that is, where the FDA has determined that the NDA contains all the sufficient information on Stedesa. The New Drug Application is now under “formal review” by the FDA.

Sepracor Inc. is expecting the Prescrption Drug User Fee Act date (also called Action date or just PDUFA date) date to be January 30, 2010. This is the date on which the Food & Drug Administration must respond to the company’s new drug application. If approved by the FDA, Stedesa – which is the brand name for the generic drug eslicarbazepine acetate – can be used as an “adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy”.

Epilepsy is a type of neurological disease. According to the Epilepsy Foundation, this condition is one of the most common forms of neurological disorder – affecting more than 2.7 million people in the U.S. alone. Patients with Epilepsy suffer from unusual shots of impulses from the nerve cells in the body.

Adrian Adams, who is the Chief Executive Officer and also the President of Sepracor, was very happy after the FDA’s acceptance. He said,

“We are very pleased to continue the advancement of STEDESA as a potential new adjunctive treatment for partial-onset epilepsy. STEDESA represents a significant and near-term opportunity for Sepracor, and the FDA acceptance of the NDA is yet another step forward in one of our near- and mid-term corporate objectives of expanding and advancing our pharmaceutical product pipeline.”