Pharmaceutical Processing World

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

BioCryst Wants to Extend IV Flu Drug Study

By Pharmaceutical Processing | January 14, 2011

RESEARCH TRIANGLE
PARK, N.C. (AP) — BioCryst
Pharmaceuticals Inc. said Thursday that it wants to extend and expand a
late-stage clinical trial of its intravenous flu drug peramivir.

Its shares fell 40 cents, or 7.8 percent, to $4.76 in midday
trading.

The company said it wants to increase the size of the trial.
It also wants to change the main goal of the trial so it can compare patients
treated with peramivir to those who have not been treated with neuraminidase
inhibitors, a group of drugs that includes peramivir and Tamiflu, among other
drugs. BioCryst said the changes would highlight peramivir’s effects and make
it more likely the drug will gain regulatory approval.

The changes would make the trial last longer, the company
said, as it would be hard to enroll enough patients by the end of 2011. That is
when enrollment of patients is currently scheduled to end. The revisions need
to be approved by the Food and Drug Administration and by the Department of Health
& Human Services, which is helping fund development of peramivir.

Peramivir is intended for patients who are hospitalized and
too sick to take an oral flu drug. It is on the market in Japan and Korea,
but is not yet approved in the U.S.

BioCryst also reported results from a late-stage safety
trial of peramivir. In the study, 230 patients were treated with peramivir
during the 2009-2010 swine flu epidemic. The patients were treated with 600
milligrams per day for five days, receiving the drug either once per day or in
two doses of 300 milligrams per day. BioCryst said the groups had similar
changes in virus levels and similar side effects.

Patients who needed more treatment after five days were
given another five days of peramivir infusions. It said 170 of the patients had
previously been treated with Tamiflu. The study included patients who were
hospitalized with confirmed or suspected flu.

BioCryst said 20 percent of the patients experienced a
serious side effect. The most common of those side effects were respiratory
failure or distress, septic shock, and kidney failure. One patient experienced
elevated levels of liver enzymes. The company said 8.7 percent of patients died
within four weeks of treatment, but no deaths were attributed to peramivir.

 

Related Articles Read More >

Great Point Partners logo.
Great Point Partners acquires majority stake in Eutecma to fuel sustainable cold chain growth
Driving success in fast-paced high-tech pharma construction projects
This is a photo of the Fujifilm Diosynth Biotechnologies plant under construction in Holly Springs, North Carolina.
Fujifilm, Regeneron ink $3B U.S. manufacturing agreement
This is the logo of Johnson & Johnson.
J&J breaks ground on $2B manufacturing facility in North Carolina
“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