Lipocine Resubmits NDA for Its Oral Testosterone Product Candidate, LPCN 1021, for Treatment of Hypogonadism
August 09 2017 - 8:00AM
Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company,
today announced the resubmission of a New Drug Application (“NDA”)
for LPCN 1021, its oral testosterone product candidate for
testosterone replacement therapy (“TRT”) in adult males for
conditions associated with a deficiency of endogenous testosterone,
also known as hypogonadism.
Lipocine had previously submitted an NDA for LPCN 1021 and
received a Complete Response Letter (“CRL”) from the U.S. Food and
Drug Administration (“FDA”) in June 2016. The CRL identified a
deficiency related to the dosing algorithm for the proposed
label. With the goal of addressing this deficiency, the
company successfully completed a dosing validation (“DV”) study,
which confirmed the validity of a fixed dose approach without the
need for dose titration to orally administer LPCN 1021. The
efficacy results of the DV study, as well as an integrated safety
set (“ISS”) from all previously conducted clinical trials,
including 52-week safety results from the Phase 3 Study of Androgen
Replacement (“SOAR”) clinical study, form the basis for the NDA
resubmission.
“Resubmission of this NDA as planned is an important milestone
in bringing LPCN 1021 to patients,” said Dr. Mahesh Patel,
Chairman, President and Chief Executive Officer of Lipocine. “We
believe the results from the recently completed DV study address
the label-related deficiency identified by the FDA in the CRL. We
consider LPCN 1021 to be a differentiated TRT option for treating
hypogonadism in men. We anticipate a six-month review by the FDA
with a projected PDUFA date in the first quarter of 2018 assuming
the FDA acknowledges our submission is a complete
response.”
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 novel oral
prodrug of testosterone containing testosterone undecanoate, is
designed to help restore normal testosterone levels in hypogonadal
men. LPCN 1021 was well tolerated and met the primary efficacy
end-points in Phase 3 testing with twice daily dosing. LPCN
1111, a novel oral prodrug of testosterone, originated 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 is potentially the first oral
hydroxyprogesterone caproate product candidate indicated for the
prevention of recurrent preterm birth and has been granted orphan
drug designation by the FDA. An End of Phase 2 meeting with the FDA
has been 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 product candidates and
related clinical trials and the FDA review process relating to its
product candidates, our belief that we have addressed the CRL
deficiency, the expected timing of the FDA review process related
to our resubmitted NDA, the path to approvability by the FDA of
Lipocine’s development programs, 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 any of our products, risks
related to our products, expected product benefits not being
realized, clinical and regulatory expectations and plans not being
realized, new regulatory developments and requirements, risks
related to the FDA approval process including that the FDA will
determine there are deficiencies in our resubmitted NDA, the
receipt of regulatory approvals, the results and timing of clinical
trials, 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:
Hans Vitzhum
Phone: (646) 597-6979
hans@lifesciadviors.com
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