SALT LAKE CITY, June 7, 2018 /PRNewswire/ -- Lipocine Inc.
(NASDAQ: LPCN), a specialty pharmaceutical company, today announced
the dosing of the first subject in the ambulatory blood pressure
("ABPM") clinical study for TLANDO™, the Company's 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. This
study was initiated after receiving FDA feedback on the ABPM
clinical study protocol and is being conducted to definitively
characterize TLANDO's blood pressure effect, if any.
"We are pleased to have dosed the first subject in the ABPM
study for TLANDO, which is expected to provide data by year end. We
expect this additional data will address the blood pressure related
concern cited in the Complete Response Letter," said Dr.
Mahesh Patel, Chairman, President
and Chief Executive Officer of Lipocine.
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
TLANDO, LPCN 1111 and LPCN 1107. TLANDO, a novel oral prodrug
of testosterone containing testosterone undecanoate, is designed to
help restore normal testosterone levels in hypogonadal men.
TLANDO received a Complete Response Letter from the FDA on
May 8, 2018. 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, the timing of completion of clinical trials
including the ABPM study for TLANDO, 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 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.
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SOURCE Lipocine Inc.