SALT
LAKE CITY, Feb. 6, 2025 /PRNewswire/ -- Lipocine Inc.
(NASDAQ: LPCN), a biopharmaceutical company leveraging its
proprietary technology platform to augment therapeutics through
effective oral delivery, today announced receipt of revised
regulatory guidance for LPCN 1154 which the Company is developing
for postpartum depression (PPD) treatment. As previously
disclosed, the Company was scheduled to meet with the U.S. Food and
Drug Administration (FDA or the Division) in Q1 2025 to discuss the
NDA submission package of LPCN 1154. Following the meeting, the
Company was advised that the Division believes, in addition to the
previously completed PK bridge data, an efficacy and safety study
of oral LPCN 1154 in the target population will be
required for 505(b)(2) NDA submission.
Lipocine remains committed to advancing a rapid relief treatment
for postpartum depression. Based on the guidance received and
observed comparable exposure of LPCN 1154 and the reference drug in
the completed PK bridge study, Lipocine is planning next steps
toward the execution of a phase 3 safety and efficacy study.
"The regulatory guidance regarding a safety and efficacy study
provides an opportunity to generate safety and depression symptom
relief data with LPCN 1154, which we believe will be beneficial for
potential inclusion in product labeling and eligibility for
clinical investigation exclusivity for a 48-hour, oral treatment
option," said Mahesh Patel, CEO of
Lipocine. "Furthermore," Dr. Patel added, "the planned study will
investigate the potential of oral brexanolone to treat anxiety
disorders, representing another attractive commercial opportunity
with a high unmet need."
About LPCN 1154
LPCN 1154 is an oral formulation of brexanolone in development
targeted for administration resulting in rapid relief of PPD.
Brexanolone is a bioidentical to naturally occurring
neuroactive steroid, allopregnanolone, a positive allosteric
modulator of y-aminobutyric acid (GABAA) receptor.
LPCN 1154 is expected to have characteristics that could be
particularly appealing to patients with severe PPD, acutely
elevated suicide risk, and in whom rapid improvement is a
priority while presenting no significant risk of adverse reactions
to breastfed infants from exposure to brexanolone.
About Postpartum Depression and Unmet Needs
PPD is a major depressive disorder with onset either during
pregnancy or within four weeks of delivery, with symptoms
persisting up to 12 months after childbirth. Hormonal changes
leading to GABA dysfunction are common in depression and pregnancy.
Symptoms of PPD include hallmarks of major depression,
including, but not limited to, sadness, depressed mood, loss of
interest, change in appetite, insomnia, sleeping too much, fatigue,
difficulty thinking/concentrating, excessive crying, fear of
harming the baby/oneself, and/or thoughts of death or suicide.
Results from a recent survey (Truist Securities
Research, January 2024) show that obstetricians believe
approximately 20-40% of their patients may suffer from PPD.
Further, obstetricians are comfortable making a diagnosis and
prescribing antidepressants for PPD. Traditional
antidepressants, not approved for PPD, have slow onset of action,
side effects such as weight gain, and do not demonstrate adequate
remission post-acute treatment.
About Lipocine
Lipocine is a biopharmaceutical company leveraging its
proprietary technology platform to augment therapeutics through
effective oral delivery to develop differentiated products.
Lipocine has drug candidates in development as well as drug
candidates for which we are exploring partnerships. Our drug
candidates represent enablement of differentiated, patient friendly
oral delivery options for favorable benefit to risk profile which
target large addressable markets with significant unmet medical
needs.
Lipocine's clinical development candidates include: LPCN 1154,
oral brexanolone, for the potential treatment of postpartum
depression, LPCN 2101 for the potential treatment of epilepsy, LPCN
2203 an oral candidate targeted for the management of essential
tremor, LPCN 2401 an oral proprietary anabolic androgen receptor
agonist, as an adjunct therapy to incretin mimetics, as an aid for
improved body composition in obesity management and LPCN 1148, a
novel androgen receptor agonist prodrug for oral administration
targeted for the management of symptoms associated with liver
cirrhosis. Lipocine is exploring partnering opportunities for
LPCN 1107, our candidate for prevention of preterm birth, LPCN
1154, for rapid relief of postpartum depression, LPCN 2401 for
obesity management, LPCN 1148, for the management of decompensated
cirrhosis, and LPCN 1144, our candidate for treatment of
non-cirrhotic NASH. TLANDO, a novel oral prodrug of
testosterone containing testosterone undecanoate developed by
Lipocine, is approved by the FDA for conditions associated with a
deficiency of endogenous testosterone, also known as hypogonadism,
in adult males. 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 our product candidates and related
clinical trials, our development of our product candidates and
related efforts with the FDA, including with respect to LPCN 1154,
our current intention to conduct a safety and efficacy study
relating to LPCN 1154, the timing and potential results of the
safety and efficacy study relating to LPCN 1154, the timing of our
submission of a NDA with the FDA for LPCN 1154, and the potential
uses and benefits of our product candidates. Investors are
cautioned that all such forward-looking statements involve risks
and uncertainties, including, without limitation, the risks that we
may not be successful in developing product candidates, we may not
have sufficient capital to complete the development processes for
our product candidates or we may decide to allocate our available
capital to other product candidates, we may not be able to enter
into partnerships or other strategic relationships to monetize our
non-core assets, safety and efficacy studies, including those
relating to LPCN 1154, may not be successful or may not provide
results that would support the submission of a NDA, 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 the receipt of regulatory approvals and
our ability to utilize a streamlined approval pathway for LPCN
1154, 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.
