Visitors Now:
Total Visits:
Total Stories:
Profile image
By ProactiveInvestors (Reporter)
Contributor profile | More stories
Story Views

Now:
Last Hour:
Last 24 Hours:
Total:

Flamel receives FDA approval for its narcolepsy treatment

Thursday, October 6, 2016 7:45
% of readers think this story is Fact. Add your two cents.

(Before It's News)

The Irish subsidiary of Flamel Technologies (NASDAQ:FLML) has taken a big leap forward as it looks to push on with the Phase III trial of its FT218 narcolepsy treatment.

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

Report abuse

Comments

Your Comments
Question   Razz  Sad   Evil  Exclaim  Smile  Redface  Biggrin  Surprised  Eek   Confused   Cool  LOL   Mad   Twisted  Rolleyes   Wink  Idea  Arrow  Neutral  Cry   Mr. Green

Top Stories
Recent Stories

Register

Newsletter

Email this story
Email this story

If you really want to ban this commenter, please write down the reason:

If you really want to disable all recommended stories, click on OK button. After that, you will be redirect to your options page.