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Posted by on Nov 24, 2008 in FDA, Neurology

FDA Approvals for Neuro Drugs Triple in 2008

FDA Approvals for Neuro Drugs Triple in 2008

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Alright. Hyperbole acknowledged.

This year, 3 new chemical entities for the treatment of neurologic diseases were approved by the FDA; whereas in 2007, the FDA approved only 1 new drug for a neurologic condition. The agency’s latest nod is for Banzel (rufinamide; Eisai), which was approved on Friday for the adjunctive treatment of Lennox-Gastaut syndrome, an uncommon and notoriously refractory form of epilepsy.

The 2 other neuro drugs approved this year were Xenazine (tetrabenazine; Prestwick), which received approval (via priority review) on August 15 for the treatment of chorea in Huntington’s disease, and Vimpat (lacosamide; UCB), which received standard-review approval on October 28 for the adjunctive treatment of partial-onset seizures in adults.*

Although the IN VIVO Blog points out that there are several more drug applications pending this year at the FDA, none is seeking an indication for a traditionally defined neuro disease.

On May 9, 2007, the FDA approved another neuro drug from UCB, Neupro (rotigotine), for the transdermal treatment of early-stage idiopathic Parkinson’s disease. However, the company stumbled when crystal formation was discovered on its Neupro patches, which necessitated a US recall earlier this year.

* In July, the FDA denied approval for the use of lacosamide in diabetic neuropathic pain.

bmartin (1109 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.


1 Comment

  1. I have a friend who I help and have power of attorney for. He has suffered from Restless Leg Syndrom for years. His doctors ordered the Neuro-patch for him. This patch worked immediately without any problems. However this patch was pulled by FDA from United States for some delivery problems. He has tried other medications without any success. We know we can obtain the Neuro patch from other countries, but he has no insurance that covers him for medication outside of the United States. This is reaching a serious situation for him, from the severe jerking of his arms and legs and body to inability to sleep. When the jerking starts, he can get up from a sitting or lying position and walk which will bring his body under control, but as soon as he relaxes, sitting or lying down the jerking starts again, Please advise if there is any possibility this patch will be approved again for use in the United States.
    Is there a chance the Neuro patch will be accepted again in the United States to help people such as my friend. He had no adverse effects from the patch.