Acorda Therapeutics’ Fampridine-SR likely to receive FDA app

[scorpion]

Acorda Therapeutics’ (NASDAQ:ACOR) Fampridine-SR, a drug that is designed to improve walking ability in patients with multiple sclerosis, will likely receive FDA approval later this month, despite its increased risk for seizures, neurologists and a source close to the situation told Pharmawire.

FDA briefing documents will be available on 12 October. The company is expecting an FDA decision on 22 October.

But according to risk management consultants who previously worked at the FDA, the drug will likely receive a strict risk management (REMS) procedure and a black box warning for seizure risk.

Patients with multiple sclerosis will ultimately face difficulties with walking, as their disease progresses. In clinical trials, Fampridine-SR has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged.

[CureOrBust]

But according to risk management consultants who previously worked at the FDA, the drug will likely receive a strict risk management (REMS) procedure and a black box warning for seizure risk.

It must burn em a little that people who get it via compounding now, don't get the "black-box" warning.

Any info regarding how Fampridine-SR's release will effect the access to compounded versions of 4-AP? It will also be interesting to see the price difference.