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East
Windsor, NJ, October 20, 2008
-- NexMed, Inc. (Nasdaq: NEXM),
a developer of innovative treatments
based on the NexACT technology,
announced today that it met
with the Food and Drug Administration
(FDA) on October 15, 2008 concerning
Vitaros® , its topical treatment
for erectile dysfunction. The
purpose of the meeting was to
gain clarification on the major
deficiencies cited by the FDA
in their July 21, 2008 action
letter (the "Action Letter")
and to reach consensus on the
necessary actions for addressing
these deficiencies for its Vitaros®
New Drug Application (NDA).
A summary of the key regulatory
concerns and agreements by the
participants is as follows:
1. Overall Carcinogenicity
Assessment: The Division has
agreed to NexMed's request for
a review of this assessment
by the Carcinogenicity Advisory
Committee (CAC) prior to NexMed's
Class 2 resubmission in reply
to the Action Letter. The CAC
will review NexMed's briefing
package, which includes the
results from its three, two-year
carcinogenicity studies in mice
and rats, and determine whether
the new weight of evidence can
alleviate the FDA's concerns
over the positive results from
the TgAC (transgenic mouse)
study. NexMed plans to submit
this briefing package for CAC
review by the end of the year.
2. Assessment of the transfer
to the partner of NexMed's NexACT®
technology: The Division concurs
with NexMed's proposal to conduct
one Phase 1 study in healthy
volunteers, with the design
of the trial to be determined.
3. Assessment of transmission
of sexually transmitted diseases
(STDs): The Division concurs
with NexMed's proposal to conduct
one animal study, with the animal
model to be determined.
4. GMP (Good Manufacturing
Practices) Status of NexMed's
manufacturing facility: NexMed
has adequately addressed the
deficiencies cited in FDA's
Pre-Approval Inspection and
the FDA has revised the status
from "withhold" to
"acceptable."
Vivian Liu, NexMed's Chief
Executive Officer commented,
"We had a very productive
meeting with representatives
of the FDA. We now have a well-defined
roadmap as to the actions necessary
for addressing the deficiencies
for our Vitaros® NDA prior
to our Class 2 resubmission."
Hem Pandya, NexMed's Chief
Operating Officer, commented,
"We remain positive about
the viability and approvability
of our product. We know from
the feedback we have received
that there is real demand for
Vitaros® from both patients
and the urology community at
large. Once we obtain feedback
from the CAC and additional
input from the FDA regarding
any remaining outstanding issues,
we will be better able to provide
guidance on the estimated timeline
for our Class 2 resubmission
in reply to the Action Letter.
Once the Class 2 resubmission
has been made, the FDA will
then start the six month review
clock."
NexMed Management will provide
an update on the Vitaros action
items during its third quarter
conference call on November
11, 2008, details of which will
be issued closer to the date
of the call.
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