Transcept Pharmaceuticals Provides Update on Intermezzo(R) Regulatory Review
22 Februar 2010 - 10:35PM
PR Newswire (US)
POINT RICHMOND, Calif., Feb. 22 /PRNewswire-FirstCall/ -- Transcept
Pharmaceuticals, Inc. (NASDAQ:TSPT) announced today an update on
its plans to seek U.S. Food and Drug Administration (FDA) approval
of Intermezzo® (zolpidem tartrate sublingual tablet) for use
as-needed for the treatment of insomnia when a middle of the night
awakening is followed by difficulty returning to sleep. Transcept
met with the FDA on January 20, 2010 to discuss the Complete
Response Letter (CRL) dated October 28, 2009, and received the
official FDA minutes of this meeting on February 19, 2010.
Subsequent to the meeting, Transcept submitted a revised proposal
for the resubmission of the Intermezzo® New Drug Application (NDA)
to the FDA for evaluation and comment. October 28, 2009 Complete
Response Letter As previously announced, the FDA stated in the CRL
that it believes Transcept has submitted substantial evidence of
effectiveness for the use of Intermezzo® in the as-needed treatment
of insomnia when a middle of the night awakening is followed by
difficulty returning to sleep. However, the FDA indicated that the
intended use of Intermezzo® in the middle of the night represents a
unique insomnia indication and dosing strategy for which safety has
not been previously established, and that the Intermezzo® NDA could
not be approved in its present form. The FDA further recognized
that the Intermezzo® data submitted by Transcept did not indicate
next day residual effects significantly different from placebo.
However, the FDA requested additional data demonstrating that
Intermezzo®, when taken as directed in the middle of the night,
would not present an unacceptable risk of residual effects, with
particular reference to next day driving ability. The FDA expressed
two concerns regarding the possibility of patient dosing errors in
the middle of the night that could lead to next day residual
effects, with particular reference to next day driving ability.
Specifically, the FDA asked Transcept to address methods to avoid
inadvertent dosing with less than four hours of bedtime remaining
and inadvertent re-dosing in a single night. Redesigned Packaging
and Patient Instructions In the briefing document submitted prior
to the January 20, 2010 meeting, Transcept proposed a new
Intermezzo® bedside unit-dose package and patient instructions
designed to reduce the possibility of patient dosing errors. In the
meeting minutes, the FDA indicated that the revised packaging
appeared to reduce the potential for inadvertently taking more than
one dose in a single night. However, the FDA expressed a remaining
concern that the revised packaging may not adequately address the
risk of dosing with less than four hours of time remaining in bed,
with particular regard to the possibility of impaired driving.
Transcept and the FDA also reviewed the types of data that could
support the evaluation of the proposed packaging and instructions,
including data from pre-approval assessments of patient
understanding of dosing instructions and a potential patient use
study of the new Intermezzo® packaging. As requested by the FDA,
Transcept has provided information on the challenges and
limitations of pre-approval patient use studies, and has submitted
a plan to assess and optimize patient understanding of the new
packaging and patient instructions. Intermezzo® Safety Profile
Characterization To further understand the safety of dosing
Intermezzo® in the middle of the night, Transcept has proposed to
the FDA to conduct a pre-approval highway driving study to assess
the effect of Intermezzo® on driving ability beginning at
approximately three hours and four hours post-dosing. Transcept has
also submitted additional supportive analyses of data from a
previously conducted Intermezzo® pharmacokinetic and
pharmacodynamic study at time points up to four hours post-dosing.
Results from this study were published in a 2008 article titled
"Daytime pharmacodynamic and pharmacokinetic evaluation of low-dose
sublingual transmucosal zolpidem hemitartrate" in the journal Human
Psychopharmacology, an abstract of which is publicly available at
http://www.interscience.wiley.com/. FDA Review of Transcept
Post-Meeting Proposals In the meeting on January 20, 2010, the FDA
agreed to review the revised proposal for the Intermezzo® NDA
resubmission and consider its adequacy to support the potential
approval of Intermezzo®. The FDA has not set a date for the
completion of its review of this proposal or the timing of its
response to Transcept. Transcept plans to provide an update on the
Intermezzo® development program, as appropriate, after it receives
the results of the FDA's review of the revised proposal. Glenn A.
Oclassen, President and Chief Executive Officer of Transcept,
commented, "We are encouraged by the progress made in our recent
interactions with the FDA, and appreciate the FDA's willingness to
engage in a collaborative dialogue in order to help define the
steps necessary for us to resubmit the Intermezzo® NDA." About
Transcept Pharmaceuticals Transcept Pharmaceuticals, Inc. is a
specialty pharmaceutical company focused on the development and
commercialization of proprietary products that address important
therapeutic needs in neuroscience. The most advanced Transcept
product candidate is Intermezzo® (zolpidem tartrate sublingual
tablet), for which a New Drug Application (NDA) was submitted to
the U.S. Food and Drug Administration (FDA) in September 2008
seeking approval as a prescription sleep aid for use in the middle
of the night at the time a patient awakens and has difficulty
returning to sleep. In October 2009, Transcept received a Complete
Response Letter from the FDA on the Intermezzo® NDA and is working
to respond to issues raised in the letter. Transcept and Purdue
Pharmaceutical Products, L.P. have entered into a collaboration
agreement for the development and commercialization of Intermezzo®
in the United States. For further information, please visit the
company's website at: http://www.transcept.com/. Forward Looking
Statements This press release contains forward looking statements
for purposes of the Private Securities Litigation Reform Act of
1995 (the Act). Transcept disclaims any intent or obligation to
update these forward-looking statements, and claims the protection
of the safe harbor for forward-looking statements contained in the
Act. Examples of such statements include, but are not limited to,
the sufficiency of Transcept proposals to the FDA, data submitted
and data that may be generated and submitted in support of the NDA
for Intermezzo® to receive FDA approval of Intermezzo® for its
intended indication, including whether or not additional clinical
or non-clinical studies will be required to obtain FDA approval;
the existence, timing and potential outcome of regulatory decisions
by, and feedback from, the FDA; and the potential for Intermezzo®
to be approved by the FDA for use in the middle of the night at the
time a patient awakens and has difficulty returning to sleep. Such
statements are based on management's current expectations, but
actual results may differ materially due to various risks and
uncertainties, including, but not limited to, whether additional
data exists or can be generated from existing or new clinical
studies to demonstrate sufficiently to the FDA that Intermezzo®
would not present an unacceptable risk of residual effects,
including residual effects that impair next day driving ability;
whether Transcept can sufficiently demonstrate to the FDA that it
can reduce dosing errors in the middle of the night or that dosing
errors will not lead to unacceptable next day residual effects; FDA
decisions on the sufficiency of other data submitted in support of
the Intermezzo® NDA to receive approval for its intended indication
and any further delays in, and the final form of, any FDA approval
of Intermezzo®; and other difficulties or delays in, clinical
development, market acceptance and commercialization of
Intermezzo®. These and other risks are described in greater detail
in the "Risk Factors" section of our most recent quarterly report
on Form 10-Q filed with the United States Securities and Exchange
Commission. Our forward-looking statements do not reflect the
potential impact of any future acquisitions, mergers, dispositions,
joint ventures or investments we may make. We do not assume any
obligation to update any forward-looking statements. Contact:
Transcept Pharmaceuticals, Inc. Greg Mann Director, Corporate
Communications (510) 215-3567 DATASOURCE: Transcept
Pharmaceuticals, Inc. CONTACT: Greg Mann, Director, Corporate
Communications of Transcept Pharmaceuticals, Inc., +1-510-215-3567,
Web Site: http://www.transcept.com/
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