Please login to the form below

Not currently logged in
Email:
Password:

FDA rejects GSK and Xenoport's Horizant

GSK and XenoPort, have received a Complete Response letter from the US FDA relating to Horizant (gabapentin enacarbil)

GlaxoSmithKline (GSK) and XenoPort, have received a Complete Response letter from the US Food and Drug Administration (FDA) relating to Horizant (gabapentin enacarbil), an investigational non-dopaminergic treatment for moderate-to-severe primary Restless Legs Syndrome (RLS).

The two companies submitted a New Drug Application (NDA) for Horizant extended-release tablets, to the FDA in January 2009.

The FDA's Center of Drug Evaluation and Research issue Complete Response letters once a review is completed, but when there are questions outstanding that prevent the NDA from being approved.

In the case of Horizant, the FDA indicated that a preclinical finding of pancreatic acinar cell tumours in rats was of sufficient concern to prevent approval of Horizant for RLS at this time.

GSK and Xenoport are evaluating the Complete Response letter and will communicate their intended next steps to the FDA.

Horizant is developed from a variant of Pfizer's Nerontin (gabentin), used to control seizures in epilepsy patients. Similar preclinical findings to those for Horizant were known for gabapentin when the FDA approved its use for refractory epilepsy. However, the FDA state that the 'seriousness and severity of refractory epilepsy justified the potential risks'.

Gabapentin enacarbil is also being developed in partnership with Astellas Pharma for the potential treatment of Restless Legs Syndrome in Japan. 

18th February 2010

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Purple Agency

An Integrated Marketing Communications Agency with a passion for Intelligent Strategy, Compelling Creativity and Professional Delivery....

Latest intelligence

How innovating study sites can improve patient recruitment efficiency
There are so many ways that clinical trials have innovated over the last few years. There is now a larger focus on making trials more patient-centric, more virtualised, and more...
PME-MAY21-Cover
Avoiding A Series of Unfortunate Events: launch lessons from lockdown
Chris Ross takes a novel look at launch excellence through the lens of COVID-19 and explores how pharma’s launch leaders are rewriting the story...
6 reasons patients drop out of clinical trials and 6 ways to fix it
If you’ve successfully recruited patients for your clinical trial, but one by one, they begin to drop out, then this information could be for you....