- Lipocine and FDA agreed on the acceptance criteria for the
pivotal study which enables advancement of LPCN 1154 for postpartum
depression (PPD)
- Company on track to initiate dosing in the pivotal study
Q1'24
SALT
LAKE CITY, Oct. 26, 2023 /PRNewswire/ -- Lipocine
Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on
treating Central Nervous System (CNS) disorders by leveraging its
proprietary platform, today announced the completion of a meeting
with the FDA and guidance for the appropriate acceptance criteria
for the upcoming LPCN 1154 pivotal study.
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. LPCN 1154 is
targeted to be a differentiated oral option with rapid-onset,
robust efficacy, and short treatment duration as a mono or add-on
therapy for patients with unresolved depression symptoms.
Following positive results from the pilot PK bridge study,
Lipocine completed a successful meeting with the U.S. Food and Drug
Administration (FDA) on October 18th
with agreement on the following:
- Confirmation of Lipocine's proposal for a 505(b)(2) NDA
filing based on a single pivotal study comparing exposure of LPCN
1154 with the approved IV infusion of brexanolone
- The use of exposure parameters and criteria to assess
comparable exposure to IV infusion brexanolone
Consistent with the goal to file a New Drug Application (NDA) in
2024, the company anticipates beginning the pivotal study program
in Q1'24 with LPCN 1154 "to be marketed" formulation. Top
line results from the study are expected by Q2 '24.
"We are thankful for FDA's guidance and are pleased to reach an
agreement on key elements of pivotal study design and other
components required for registration," said Dr. Mahesh Patel,
President and CEO of Lipocine Inc. "PPD is a serious
condition, and we are developing LPCN 1154 to be a highly
effective, oral, fast-acting and short duration treatment option.
We believe rapid relief within 3 days will be important for
patients and, if approved, LPCN 1154 has the potential to be a
differentiated preferred treatment option for PPD."
About LPCN 1154
LPCN 1154 is an oral formulation of brexanolone in development
targeted for administration resulting in rapid relief of postpartum
depression (PPD). Brexanolone is a bioidentical to naturally
occurring neuro active steroid, allopregnanolone, a positive
allosteric modulator of y-aminobutyric acid (GABA)
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.
Approximately 500,000 women are affected by PPD annually in
the United States and, according
to the CDC, an estimated 175,000 women suffer from moderate to
severe PPD. Traditional antidepressants, not approved for PPD, have
slow onset of action, side effects such as sexual dysfunction and
weight gain, and do not demonstrate adequate
remission post-acute treatment. The current approved standard
of care is a continuous infusion of intravenous brexanolone which
requires inpatient administration and has significant
limitations.
About Lipocine
Lipocine is a biopharmaceutical company leveraging its
proprietary technology platform to augment therapeutics through
effective oral delivery to develop products for CNS disorders.
Lipocine has candidates in development as well as candidates for
which we are exploring partnering. Our candidates represent
enablement of patient friendly oral delivery options for favorable
benefit to risk profile which target large addressable markets with
significant unmet medical needs.
Lipocine clinical development candidates include: LPCN 1154,
oral brexanolone, for the potential treatment of postpartum
depression, LPCN 2101 for the potential treatment of epilepsy and
LPCN 1148, an oral prodrug of bioidentical testosterone 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 1148, for the
management of decompensated cirrhosis, LPCN 1144, our candidate for
treatment of non-cirrhotic NASH, and LPCN 1111, a once-a-day
therapy candidate for testosterone replacement therapy (TRT).
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 development efforts, our strategic plans for
developing products to treat CNS disorders, our ability to monetize
non-core product candidates, including through entering into
partnering arrangements, the application of our proprietary
platform in developing new treatments for CNS disorders, our
product candidates and related clinical trials, the achievement of
milestones within and completion of clinical trials, the timing and
completion of regulatory reviews, outcomes of clinical trials of
our product candidates, 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 to treat CNS disorders,
we may not be able to enter into partnerships or other strategic
relationships to monetize our non-core assets, 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.