Acorda shares sink (NASDAQ:ACOR)
It was a not a good closing day for Acorda Therapeutics when shares of its company went down drastically after the negative review by the Food and Drug Administration panel. On Friday evening, the FDA gave out a negative opinion that questioned the safety and effectiveness of the multiple sclerosis drug made by the company. Acorda Therapeutics is a biotechnology company that develops and market therapies that restore neurological function in people who are suffering from spinal cord injury and multiple sclerosis and other conditions related to the nervous system. Currently, Acorda Therapeutics’ Zanaflex Capsules and Zanaflex are two commercially successful drugs which are short acting drugs approved by the FDA and the management of spasticity.
In June 2008, Acorda Therapeutics announced positive results in the Phase 3 clinical trial of their new drug Fampridine-SR and early this year, Acorda went ahead and filed the New Drug Application for Fampridine-SR with FDA which was later approved. However, currently this drug is under FDA scrutiny which led to the downfall of Acorda’s shares in the market.
A panel of FDA advisers is scheduled to meet in the coming week where they will vote on Acorda Therapeutics’ Fampridine-SR, which is designed to improve the walking ability of those suffering from multiple sclerosis (MS). Multiple Sclerosis affects the brain and nervous system that causes muscle spasms, loss of balance and other movement problems.
On Friday, FDA gave out their opinion that Fampridine-SR had more risks compare to the benefits and therefore they are not very sure about this new drug developed by Acorda. Though the company has conducted two successful trials where the patients were able to walk a distance of 25 feet, FDA are really not happy with the range of advantages it has.
According to FDA, the studies showed by Acorda Therapeutics does meet the goal of improving patients walking capabilities when compared with those on placebo, but Fampridine-SR does not show improvement on the actual time to complete the exercise. Hence, for these reasons the clinical differences seen on the primary outcomes is in the question.
FDA scientists have also noticed that the drug increases the risks of seizures and urinary tract infections that is what Acorda Therapeutics will need to watch out for. In one of the statements made by Acorda Therapeutics, they have stated that the risk of seizures is seen only when there is increase in the dosage. Acorda expects the FDA to complete its final review by Oct. 22.