Extended release ... extended

Shocking? ... No.

Disappointing? ... Yes.

On October 14th 2009, the Peripheral and Central Nervous System Advisory Committee (panel) to the FDA's Acorda (ACOR), questioned Acorda about their planned REMS (Risk Evaluation and Mitigation Strategy) for Amaya (Fampridine-SR).

In response to this, Dr. Ron Cohen (President and CEO of Acorda Therapeutics), highlighted, once again, his professionalism and dedication to patient care, by amending the NDA (New Drug Application) submitted to the FDA. This prompted the FDA to extend the PDUFA (Prescription Drug User Fee Act) date from October 22nd, 2009 to January 22nd, 2010.

So what should we, the MS community, do about this?

Instead of wallowing in self pity, we should take this opportunity to create a 4-Aminopyridine (Fampridine-SR) community of advocates.

Think about what happened when patients demanded that the FDA allow Tysabri (natalizumab) come back to the market after the original three PML cases.

So, if you like the idea of extending functioning, improving walking and moving MS functional and symptomatic treatment forward, please email us at neurologique@gmail.com.

- Dr. Daniel Kantor, MD BSE
Medical Director
Neurologique

info@neurologique.org
www.neurologique.org