• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Flamel Technologies dose first patient in Phase III narcolepsy trial

December 16, 2016 By Sarah Faulkner

Flamel Technologies dose first patient in Phase III narcolepsy trialFlamel Technologies (NSDQ:FLML) said today that the 1st patient in its Rest-On phase III clinical trial was dosed with FT218, sodium oxybate, for the treatment of excessive daytime sleepiness and cataplexy in narcolepsy patients.The Lyon, France-based company developed the controlled-release oral formulation of sodium oxybate using its Micropump technology.

The randomized, double-blind trial has enrolled 264 patients to assess the safety and efficacy of a once nightly dosage of the oral suspension of sodium oxybate. The study will be conducted at 50-60 sites throughout the U.S., Europe and Canada, according to Flamel.

“This is an exciting milestone for Flamel,” CEO Mike Anderson said in prepared remarks. “FT218 is our most important asset and has the potential to provide a number of benefits to narcoleptic patients, who suffer from debilitating quality of life issues. We are seeing significant interest in this trial from both physicians and patients alike, and are excited to continue the screening and enrollment process as more sites are initiated throughout Europe, Canada and the U.S.”

Shares in the company rose last month after the pharmaceutical company met expectations on Wall Street with its 3rd quarter results.

Flamel posted a loss of -$22.3 million on sales of $32.1 million for the 3 months ended Sept. 30, for bottom-line growth of 20% despite a sales loss of 32% compared with the same period last year.

Filed Under: Clinical Trials, Featured, Pharmaceuticals, Wall Street Beat Tagged With: Flamel Technologies

IN CASE YOU MISSED IT

  • Abbott will spend $450M to up FreeStyle Libre production in Ireland
  • Better Therapeutics Q2 beats Street as it prepares to submit diabetes therapy for FDA review
  • Study backs Fluidx embolic device for vessel filling
  • Senseonics stock is up as it sticks by revenue guidance
  • Rapid Dose closes first tranche of $5M financing

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Signup for the newsletter

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS