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news.GlaxoSmithKline (GSK) and XenoPort said that the US Food and Drug Administration (FDA) has accepted for review GSK's response to FDA's complete response letter for Horizant (gabapentin enacarbil) extended-release tablets.
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Horizant, also referred to as GSK1838262/XP13512, is a patented new chemical entity. It is under review for the treatment of moderate-to-severe primary restless legs syndrome (RLS).
FDA has designated the resubmission as a Class 2 response and set a new prescription drug user fee act goal date of 6 April 2011.
GSK has submitted its response to questions raised by FDA in a complete response letter dated 17 February 2010.
GSK’s response to FDA included new data from nonclinical studies of Horizant and two epidemiology studies, conducted by GSK, exploring gabapentin use and cancer based on the UK General Practice Research Database.
Reportedly, the resubmission also included a final safety update that provided updated or new safety information on patients in clinical studies who have been treated with Horizant.
XenoPort is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilise the body’s natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs.