Flamel Ireland Holdings has been granted a Special Protocol Assessment (SPA) by the US Food and Drug Administration.
A SPA means that the FDA is happy with the proposed design and analysis of the trial and that it “adequately addresses the objectives necessary to support a regulatory submission”.
FT218 is a once nightly formulation of sodium oxybate which uses the company’s proprietary drug delivery platform, Micropump.
It is an oral treatment that aims to help patients with narcolepsy by reducing or eliminating disruption in their night time sleeping habits.
“This is a major milestone for the trial, as we move forward with site initiation in Europe and subsequently, the United States,” said chief executive Mike Anderson.
“We believe our once nightly formulation of sodium oxybate has the potential to offer significant improvements over the current standard of care, in addition to meaningful improvement in overall quality of life for patients suffering from narcolepsy.”
Shares initially opened higher on Thursday before falling 3% to US$12.50.
Story by ProactiveInvestors