GSK delays US filing of Solzira
pharmafile | November 14, 2008 | News story | Sales and Marketing |Â Â GSK, restless legsÂ
GlaxoSmithKline has withdrawn the US application for its restless legs syndrome treatment Solzira.
The company, along with co-developer XenoPort, is to look afresh at its data and resubmit after the FDA demanded information from a single study be reformatted.
Restless legs syndrome (RLS) is a chronic neurological condition causing uncomfortable and even painful sensations in the legs that affects as many as 10% of US adults and disrupts sleep.
The Solzira extended release tablets are intended for the treatment of moderate-to-severe primary RLS.
Data includes two randomised, double-blind, placebo-controlled trials concentrating on safety over three months and a third looking at treatment over nine months.
Dizziness was among the side effects but nearly four-fifths of patients treated with 1,200 mg were "much improved" or "very much improved".
The manufacturer stressed that the withdrawal did not relate to the content of the filing.
GSK's drug is based on gabapentin, the active ingredient in Pfizer's now off-patent epilepsy treatment Neurontin, and if approved Solzira would be the first gabapentin agent available for RLS.
GSK is partnering on the drug's development with biopharma company XenoPort, which specialises in developing product candidates that use the body's nutrient transport systems to improve the therapeutic benefits of existing drugs.
Solzira is designed to improve upon the pharmacokinetics of gabapentin by using natural mechanisms in the gastrointestinal tract to improve absorption.
GSK says it will now review other trial data sets taking the FDA's order into account.
The resubmission will mean a delay in milestone payments of $23 million for XenoPort from GSK and another partner, Astellas Pharma.
XenoPort is also looking at the product's suitability for treating conditions such as migraines, spasticity related to spinal chord injury and Parkinson's disease.
Three years ago GSK launched its own Parkinson's disease drug Requip for moderate-to-severe RLS – the first medicine to receive US approval for RLS.
Approved in the US for Parkinson's in 1997, the second-generation dopamine agonist directly stimulates dopamine receptors in the brain.
Doctors believe a dysfunction of a system involving this brain chemical may be an underlying cause of the disorder.
Requip competes with another dopamine agonist, Boehringer Ingelheim's Mirapexin, and in May this year the FDA the first generic versions of GSK's drug for RLS.
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