Lipocine Inc. to Host Virtual KOL Event Highlighting Unmet Needs in Postpartum Depression and the Clinical Profile of LPCN 1154
Live webinar to take place on
The presentations will include a review of the current PPD treatment landscape, persistent gaps in care despite recent therapeutic approvals, and the Phase 3 topline results for LPCN 1154. The KOLs will provide their perspectives on the clinical relevance of the data and how the findings may inform the potential positioning of LPCN 1154 within the PPD and broader depression treatment paradigms.
Lipocine management presenting at the event will include
A Q&A session will follow the formal presentations.
Event Details
Date: | |
Time: | |
Format: | Virtual webcast with slides |
Registration: | Advance registration is required. Click here to register. |
Attendees wishing to submit questions in advance of the live Q&A session may do so by emailing [email protected].
A replay of the event will be available on the "events" page of the Lipocine corporate website.
Featured Speakers
About LPCN 1154 (BRLIZIO™)
LPCN 1154 is an investigational oral formulation of brexanolone (allopregnanolone), an endogenous neuroactive steroid and potent positive allosteric modulator (PAM) of the GABA₂ receptor. LPCN 1154 is designed to deliver bioequivalent systemic exposure to intravenous brexanolone (ZULRESSO®) via a convenient oral, at-home regimen over 48 hours, without the need for medical monitoring. The drug's mechanism of action, validated through two FDA-approved therapies (ZULRESSO® and ZURZUVAE®), is designed to provide rapid and sustained antidepressant effects in women with PPD.
In a Phase 3 randomized, placebo-controlled trial, LPCN 1154 demonstrated clinically meaningful and statistically significant efficacy across multiple timepoints in a subgroup analysis excluding an identified epidemiologic outlier site. The drug was well tolerated, with 100% of participants completing the dosing period and no treatment-related serious adverse events. LPCN 1154 is not yet approved by the FDA. BRLIZIO™ is a brand name conditionally approved by the FDA.
About Postpartum Depression
Postpartum depression is a serious and potentially life-threatening condition affecting approximately 1 in 5 women following childbirth. In
About Lipocine
Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery. 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 development pipeline includes: LPCN 1154 for the treatment of postpartum depression, LPCN 2201 for treatment of major depressive disorder, LPCN 2101 for the treatment of epilepsy, LPCN 2203 targeted for the management of essential tremor, LPCN 2401 as an aid for improved body composition in obesity management, LPCN 1148 targeted for the management of symptoms associated with liver cirrhosis, and LPCN 1107 our candidate for prevention of preterm birth. 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 development of LPCN 1154 and related efforts with the FDA, the potential uses and benefits of LPCN 1154 on the treatment of PPD, the commercial potential for LPCN 1154, and potential strategic opportunities. 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 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.
