SALT LAKE CITY, Utah,
Jan. 10, 2018 /PRNewswire/ --
Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company,
today announced that the Bone, Reproductive and Urologic Drugs
Advisory Committee ("BRUDAC") of the U.S. Food and Drug
Administration ("FDA") voted six in favor and thirteen against the
benefit/risk profile of 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. The role
of BRUDAC is to provide recommendations to the FDA. The FDA
decision on whether or not to approve the TLANDO New Drug
Application ("NDA") is anticipated by the assigned Prescription
Drug User Fee Act ("PDUFA") goal date of May
8, 2018.
"We continue to believe that efficacy and safety results from
numerous clinical studies with TLANDO are consistent with other FDA
approved TRT products," said Dr. Mahesh
Patel, Chairman, President and Chief Executive Officer of
Lipocine. "We look forward to continuing to work with the FDA
through the remainder of the review process."
The BRUDAC discussions were based on the NDA currently under
review by the FDA. The NDA includes efficacy and safety data on
TLANDO including the results from three Phase 3 clinical trials:
the Dosing Validation ("DV") clinical study, the Dosing Flexibility
("DF") clinical study and the Study of Oral Androgen Replacement
("SOAR") clinical study. Lipocine resubmitted the NDA to the
FDA in August 2017 based on the
results of the DV study. The DV study confirmed the efficacy
of TLANDO with a fixed dose regimen without the need for dose
adjustment. TLANDO successfully met the FDA primary efficacy
guidelines in the DV study safety statistical analysis set ("SS")
where 80% of the subjects achieved average testosterone levels
("Cavg") within the normal range with a lower bound confidence
interval ("CI") of 72%. TLANDO was well tolerated upon 52-week
exposure with no reports of drug related Serious Adverse Events
("SAEs").
Although the FDA will consider the recommendation of BRUDAC, the
final decision regarding the approval of TLANDO is made by the FDA
solely, and the recommendations by BRUDAC are non-binding.
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
was well tolerated and met the primary efficacy end-points in Phase
3 testing with twice daily dosing and is currently under FDA
review. 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. 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
expected timing of the FDA review process related to our
resubmitted NDA, the impact of the BRUDAC recommendation on the
FDA's decision process, 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, the risk
that BRUDAC may make a negative recommendation to the Commissioner
of the FDA with respect to TLANDO, 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.
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SOURCE Lipocine Inc.