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news.XenoPort, a biopharmaceutical company, has reported that the FDA has accepted for review the new drug application filed by GlaxoSmithKline for Solzira extended release tablets in the US as a potential treatment for moderate-to-severe primary restless legs syndrome.
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In accordance with XenoPort’s collaboration agreements with GlaxoSmithKline and Astellas Pharma the FDA’s acceptance of the new drug application (NDA) triggers milestone payments to XenoPort of $23 million in the aggregate.
Solzira is a new chemical entity that is designed to improve upon the pharmacokinetics of Solzira (gabapentin) by taking advantage of high-capacity transport mechanisms in the gastrointestinal tract to improve absorption.