Fampridine SR’s PDUFA date delayed (NASDAQ:ACOR)

Fampridine SR is a drug that has been developed by Acorda Therapeutics, Inc. (NASDAQ:ACOR). The company has already submitted the application – known as the New Drug Application (NDA) – for the approval of Food & Drug Administration to market Fampridine – SR. Upon receiving the application, the FDA has given Acorda Therapeutics Inc. a Prescription Drug User Fee Act date (also called Action date or just PDUFA date). This was the date on which the Food & Drug Administration must respond to the company’s application for approval of marketing Fampridine – SR. According to Acorda Therapeutics Inc., the PDUFA date for Fampridine – SR was October 22, 2010. However, on October 22, 2009, the corporation disclosed that the United States of America’s one of the toughest regulators, the Food and Drug Administration, has announced a three-month extension to its pending PDUFA action date. The new PDUFA is January, 22, 2010

@@CalendarRight@@ So, why did the FDA extend the PDUFA date? The answer was provided by Acorda Therapeuics itself. A few days ago the company had a meeting with the Peripheral and Central Nervous System Drugs Advisory Committee. The agenda of the meeting was obviously Fampridine – SR. After attending the meeting, Acorda Therapeutics made a few changes – which it termed as “additional information” – to the Risk Evaluation and Mitigation Strategy (REMS) program that it had earlier submitted to the FDA. Although the FDA accepted the “additional information”, it extended the PDUFA goal date since it believed that the changes were a “major amendement” to the New Drug Application of Fampridine – SR. The decision made by the FDA is perfectly legitimate since the law allows it to delay the PDUFA date whenever the sponsored company makes a “major amendement” – which brings forth a lot of new information that must be reviewed by the FDA.

Ron Cohen, who is the Chief Executive Officer and also the President of Acorda Therapeutics Inc., did not seem disappointed by the delay at all. In fact, he said,

“The REMS program is important to ensuring appropriate use of Fampridine – SR, if approved, and we are pleased that the FDA has accepted our amendment. We look forward to continuing to work with the FDA as it completes its review of the Fampridine – SR  NDA.”

@@AdsenseLeft@@ Acorda Therapeutics is a biotechnology company that prides itself on finding cure for injuries on the spinal cord, for multiple sclerosis and for other disorders of the nervous system. The corporation markets a lot of drugs, including the popular Zanaflex Capsules (also known as tizanidine hydrochloride). This is a drug that helps to keep spasticity under control, though temporarily. Acorda Therapeutics has also developed a range of drugs that treat and repair the brain and the spinal cord. One such drug is Fampridine – SR. According to the company, this drug can help the nerve fibers that have damaged layer of insulation – also known as myelin. It does this by assisting with the process of impulse conduction taking place in these Fibres. Although Fampridine – SR is developed by Acorda Therapeutics, it is manufactured by Elan Corporation plc.