Lipocine Completes Post Action Meeting With FDA for LPCN 1021 New Drug Application
17 October 2016 - 11:00PM
Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company,
today announced the completion of a Post Action meeting with the
U.S. Food and Drug Administration (“FDA”) regarding its New Drug
Application (“NDA”) for LPCN 1021, an oral testosterone product
candidate for testosterone replacement therapy ("TRT") in adult
males for conditions associated with a deficiency or absence of
endogenous testosterone, also known as hypogonadism. The
purpose of the meeting was to review the Complete Response Letter
(“CRL”) and to determine actions needed to achieve approval of LPCN
1021.
The CRL, issued June 28, 2016, identified deficiencies related
to the dosing algorithm for the label. In response to the CRL,
Lipocine proposed a dosing regimen based on analyses of existing
data. The FDA noted that while Lipocine’s proposed dosing regimen
might be acceptable, validation in a clinical
trial would be needed prior to resubmission. As a result,
Lipocine has submitted the new dosing validation clinical study
protocol to the FDA and the FDA has agreed to review the protocol
through a Special Protocol Assessment (“SPA”). An SPA is an
advanced declaration from the FDA that a planned trial's design,
clinical endpoints, and statistical analyses could potentially
result in data acceptable for FDA review towards approval for the
proposed indication.
"We were pleased to have had a very productive meeting with the
FDA with a path identified to bring our NDA for LPCN 1021 into a
position for approval," said Dr. Mahesh Patel, Chairman, President
and CEO of Lipocine. "We remain committed to bring LPCN 1021 to the
market.”
About LPCN 1021
LPCN 1021 is a novel twice-a-day oral testosterone replacement
therapy product candidate that is designed to help restore normal
testosterone levels in hypogonadal men. Lipocine expects LPCN 1021
will help fulfill an unmet need in the treatment of hypogonadism.
The current testosterone market primarily uses short-acting
injectable products as well as topical products that carry an FDA
"black box" warning related to inadvertent transfer of testosterone
to others. According to the IMS Health database, an average of half
a million prescriptions a month have been dispensed so far in 2016
for TRT.
About Lipocine
Lipocine Inc. is a specialty pharmaceutical company developing
innovative pharmaceutical products for use in men's and women's
health using its proprietary drug delivery technologies. Lipocine’s
clinical development pipeline includes three development programs
LPCN 1021, LPCN 1111 and LPCN 1107. LPCN 1021, a twice-daily oral
testosterone replacement therapy product candidate, was well
tolerated and met the primary efficacy end point in Phase 3
testing, which utilized 24-hour pharmacokinetic data for dose
adjustments. LPCN 1111, a novel prodrug of testosterone,
originated with and is being developed by Lipocine as a
next-generation oral testosterone product with potential for
once-daily dosing and is currently in Phase 2 testing. LPCN
1107, the potentially first oral hydroxyprogesterone caproate
product candidate indicated for the prevention of recurrent preterm
birth, has been granted orphan drug designation by the FDA. An End
of Phase 2 meeting with the FDA was recently completed. For more
information, please visit www.lipocine.com.
Forward-Looking Statements
This release contains “forward looking statements” that are made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995 and include statements that are not
historical facts regarding Lipocine’s FDA review process relating
to LPCN 1021, the additional clinical trial needed to validate our
dosing regimen and the FDA process with respect to our planned SPA,
the possible outcome and timing of such clinical trial or FDA
review process, the path to approvability by the FDA of LPCN 1021,
our commitment to bring LPCN 1021 to market, the potential uses and
benefits of our product candidates, and our product development
efforts. Investors are cautioned that all such forward-looking
statements involve risks and uncertainties, including, without
limitation, the risks that the FDA will not approve LPCN 1021 or
any of our other products, risks related to our products, expected
product benefits, clinical and regulatory expectations and plans,
regulatory developments and requirements, risks related to the
receipt of a CRL from the FDA for LPCN 1021, the receipt of
regulatory approvals, the results and timing of clinical trials,
including the additional clinical trial for LPCN 1021, patient
acceptance of Lipocine’s products, the manufacturing and
commercialization of Lipocine’s products, and other risks detailed
in Lipocine’s filings with the SEC, including, without limitation,
its Form 10-K and other reports on Forms 8-K and 10-Q, all of which
can be obtained on the SEC website at www.sec.gov. Lipocine assumes
no obligation to update or revise publicly any forward-looking
statements contained in this release, except as required by
law.
CONTACT:
Morgan Brown
Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383
mb@lipocine.com
Investors:
John Woolford
Phone: (443) 213-0506
john.woolford@westwicke.com
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