Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

Guilford Pharmaceuticals Restarts AQUAVAN & reg, Clinical Development Program

By Pharmaceutical Processing | April 26, 2005

BALTIMORE, Md — Guilford Pharmaceuticals Inc. recently announced that it had met with the Division of Anesthetic, Critical Care and Addiction Drug Products of the FDA and reached agreement on a revised clinical development strategy for the company’s lead product candidate, AQUAVAN Injection (GPI 15715), a novel sedative/hypnotic being developed for use in procedural sedation.

Dean J. Mitchell, President and Chief Executive Officer of Guilford, commented, “Following a very collaborative discussion with the FDA, we have agreed on a more focused clinical development strategy that reduces the number of clinical trials from 13 to 5 and includes a dose ranging study in colonoscopy. We expect that the dose ranging study will result in our identifying a dose of AQUAVAN&reg that will maximize our ability to achieve our desired label. In addition, we believe that this less complex clinical plan increases the probability of FDA approval within an optimal timeframe.”

Under the revised strategy, Guilford will immediately re-initiate its previously planned studies for ICU sedation and potential drug interactions. The design of the dose ranging trial in colonoscopy is being finalized in consultation with the FDA. Based on the findings of this study, Guilford expects to commence two pivotal trials, one in colonoscopy and the other in minor surgical procedures. Guilford continues to expect to file its New Drug Application (NDA) for AQUAVAN&reg during the second half of 2006.

Mr. Mitchell continued, “We are strongly committed to the successful and expeditious development of AQUAVAN&reg. The unique pharmacological profile of AQUAVAN&reg is optimally aligned with patient and physician needs in the procedural sedation market and offers a compelling value proposition which we believe will confer significant pharmacoeconomic benefit.”

Related Articles Read More >

Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice.
Putting patients first in clinical trials
Confidently navigate the transition from bench to batch
Merck
FDA approves Merck’s Winrevair to treat pulmonary arterial hypertension
kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

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.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. 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
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE