SALT LAKE CITY, May 9, 2018 /PRNewswire/ -- Lipocine Inc.
(NASDAQ: LPCN), a specialty pharmaceutical company, announced today
that it has received a Complete Response Letter ("CRL") from the
United States Food and Drug Administration ("FDA") regarding its
New Drug Application ("NDA") 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. A CRL is a
communication from the FDA that informs companies that an
application cannot be approved in its present form.
The CRL identified four deficiencies which include the
following: determining the extent, if any, of ex vivo
conversion of testosterone undecanoate ("TU") to testosterone ("T")
in serum blood collection tubes to confirm the reliability of T
data; obtaining definitive evidence pre-approval via an ambulatory
blood pressure monitoring study as to whether TLANDO causes a
clinically meaningful increase in blood pressure in hypogonadal
men; verifying the reliability of Cmax data and providing
justification for non-applicability of the agreed-upon and
prespecified Cmax secondary endpoints for TLANDO; and, determining
the appropriate stopping criteria that can reproducibly and
accurately identify those patients who should discontinue use of
TLANDO. The CRL also identified additional comments that are not
considered approvability issues. The next step will be to
request a meeting with the FDA to further evaluate the deficiencies
raised and to agree upon a path forward for a potential approval of
TLANDO.
"While we are disappointed by the FDA's decision, the
deficiencies identified in the CRL are within our expectations
following the meeting we had on January 10,
2018 with the Bone, Reproductive and Urologic Drugs Advisory
Committee ("BRUDAC") of the FDA. We are assessing the content
of the CRL, including the information that may be needed to resolve
the deficiencies. We remain committed to work with the FDA to
bring TLANDO to patients," 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, is currently in Phase 2
testing and has been granted orphan drug designation by the FDA.
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, the FDA review process
relating to its product candidates, the path to approvability by
the FDA of Lipocine's product candidates, 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 additional clinical trials will be
required before the FDA will consider approving TLANDO, that the
FDA may 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 any NDA we may submit or resubmit, the receipt of
receiving further complete response letters or not receiving
regulatory approvals, the results, timing, delays and monetary
costs 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.