TheraQuest Biosciences
holds Meetings with FDA, U.K. and Canadian Health Authorities on
its Injectable Non-Narcotic Analgesic
Blue Bell, PA – August 11, 2004 – PRNewswire – TheraQuest Biosciences, a development stage pain management company
today announced that
it had held a Pre-Investigational New Drug Application (IND)
conference with the United States Food and Drug Administration
(FDA) for its injectable non-narcotic (non-opioid) analgesic,
TQ-1011, for the management of moderate to severe acute pain.
The FDA's pre-IND meeting programs are designed to provide sponsors
with advance guidance and input on drug development programs.
TheraQuest has also completed consultations on TQ-1011 with the
U.K. Medicines and Healthcare Products Regulatory Agency (MHRA)
and the Canadian Therapeutic Products Directorate (TPD).
Najib Babul, PharmD, President and Chief Executive Officer of
TheraQuest stated, "TheraQuest received guidance from the
FDA's Division of Anti-inflammatory, Analgesics and Ophthalmic
Drug Products on the next steps towards submitting the IND application
for TQ-1011. This guidance will aid the TQ-1011 development program
from IND submission through to the pivotal phase III program
required for approval."
Babul also noted "In addition, TheraQuest has received
clear direction from both the U.K. and Canadian health regulatory
authorities on the requirements for approval of TQ-1011 for post-surgical
pain. The U.K. MHRA agreed to serve as the reference member state
(RMS) under the mutual recognition procedure, which means that
following U.K. approval, TheraQuest would seek further approvals
from the other E.U. member states in which TheraQuest wishes
to market TQ-1011."
The treatment of post-surgical pain has not improved in the
U.S. in recent years. Studies have shown that more than 60% of
patients who undergo surgery experience moderate to severe pain
despite existing analgesic treatments. Although opioid analgesics
are effective, they can produce many common side effects, including
nausea, vomiting, sedation, confusion, itching and constipation.
In addition, they have the potential to cause more serious side
effects, such as respiratory depression.
Raymond Sinatra, MD, PhD, who is Professor of Anesthesiology
at Yale University Medical School notes “TQ-1011 has the
potential to provide effective pain management after major inpatient
surgery, outpatient surgery and in the emergency room. In addition,
TQ-1011 may be useful in conjunction with opioids to reduce the
overall opioid requirement post-surgically.”
About TheraQuest Biosciences
TheraQuest Biosciences, LLC is a private, development-stage
pain management company building a diversified portfolio
of pharmaceutical
products to address a critical area of unmet medical need.
Despite their limitations, current treatments for acute and
chronic pain yield worldwide sales in excess of $25 billion.
The TheraQuest team has contributed to the development of
numerous analgesics approved in the U.S. over the past 20
years. TheraQuest’s
strategy is to use its expertise to identify, develop and
commercialize product candidates with strong market potential
that have lower
development costs and reduced regulatory risk than new chemical
entities. TheraQuest is headquartered in Blue Bell, Pennsylvania.
Additional information is available at www.theraquestinc.com.
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