Lipella Pharmaceuticals Granted FDA Approval for Expanded Access Program for LP-310 in Oral Lichen Planus
Lipella Pharmaceuticals (Nasdaq: LIPO) has received FDA approval for an Expanded Access Program (EAP) for LP-310, an oral rinse treatment for oral lichen planus (OLP). LP-310 is designed to provide targeted relief for OLP, a chronic inflammatory condition affecting mouth mucous membranes that impacts approximately 6 million Americans.
The EAP approval allows patients with serious or life-threatening conditions to access LP-310 outside of clinical trials before FDA approval. This is particularly significant as there are currently no FDA-approved therapies for OLP, which causes burning pain, white patches, swollen tissue, and open sores.
The company views this approval as a key milestone in addressing the unmet medical need in OLP treatment, supporting their ongoing clinical development efforts.
Lipella Pharmaceuticals (Nasdaq: LIPO) ha ricevuto l'approvazione della FDA per un Programma di Accesso Espanso (EAP) per LP-310, un trattamento con risciacquo orale per il lichen planus orale (OLP). LP-310 è progettato per fornire un sollievo mirato per l’OLP, una condizione infiammatoria cronica che colpisce le mucose della bocca e che interessa circa 6 milioni di americani.
L'approvazione dell'EAP consente ai pazienti con condizioni gravi o potenzialmente letali di accedere a LP-310 al di fuori degli studi clinici prima dell'approvazione da parte della FDA. Questo è particolarmente significativo poiché attualmente non ci sono terapie approvate dalla FDA per l’OLP, che provoca dolore bruciante, macchie bianche, tessuti gonfi e ulcere aperte.
L'azienda considera questa approvazione un traguardo fondamentale per affrontare il bisogno medico non soddisfatto nel trattamento dell’OLP, sostenendo i loro sforzi di sviluppo clinico in corso.
Lipella Pharmaceuticals (Nasdaq: LIPO) ha recibido la aprobación de la FDA para un Programa de Acceso Expandido (EAP) para LP-310, un tratamiento de enjuague bucal para el líquen plano oral (OLP). LP-310 está diseñado para proporcionar un alivio específico para el OLP, una condición inflamatoria crónica que afecta las membranas mucosas de la boca y que impacta aproximadamente a 6 millones de estadounidenses.
La aprobación del EAP permite a pacientes con condiciones graves o que amenazan la vida acceder a LP-310 fuera de ensayos clínicos antes de la aprobación de la FDA. Esto es especialmente significativo ya que actualmente no hay terapias aprobadas por la FDA para el OLP, que causa dolor ardiente, manchas blancas, tejido hinchado y llagas abiertas.
La empresa considera esta aprobación como un hito clave para abordar la necesidad médica no satisfecha en el tratamiento del OLP, apoyando sus esfuerzos de desarrollo clínico en curso.
리펠라 제약회사 (Nasdaq: LIPO)는 확장 접근 프로그램 (EAP)에 대한 FDA 승인을 받았으며, LP-310이라는 구강 세척제를 구강 편평 태선 (OLP) 치료제로 출시했습니다. LP-310은 구강 점막에 영향을 미치는 만성 염증 상태인 OLP에 대한 표적 완화를 제공하도록 설계되었습니다. 이는 약 600만 명의 미국인에게 영향을 미칩니다.
EAP 승인은 중증 또는 생명을 위협하는 상태를 가진 환자가 FDA의 승인 전에 임상 시험 외부에서 LP-310에 접근할 수 있도록 허용합니다. 현재 OLP에 대한 FDA 승인 치료제가 없기 때문에 이는 특히 중요합니다. OLP는 타는 듯한 통증, 흰 반점, 붓기 및 열린 상처를 유발합니다.
회사는 이 승인을 OLP 치료에 대한 충족되지 않은 의료 요구를 해결하는 데 있어 핵심 이정표로 보고 있으며, 지속적인 임상 개발 노력을 지원하고 있습니다.
Lipella Pharmaceuticals (Nasdaq: LIPO) a reçu l'approbation de la FDA pour un Programme d'Accès Élargi (EAP) pour LP-310, un traitement par rinçage oral pour le lichen planus oral (OLP). LP-310 est conçu pour offrir un soulagement ciblé pour l’OLP, une condition inflammatoire chronique qui affecte les muqueuses buccales et touche environ 6 millions d'Américains.
L'approbation de l'EAP permet aux patients ayant des conditions graves ou mettant leur vie en danger d'accéder à LP-310 en dehors des essais cliniques avant l'approbation de la FDA. Cela est particulièrement significatif car il n'existe actuellement aucune thérapie approuvée par la FDA pour l'OLP, qui provoque des douleurs brûlantes, des taches blanches, des tissus enflés et des plaies ouvertes.
L'entreprise considère cette approbation comme une étape clé pour répondre au besoin médical non satisfait dans le traitement de l’OLP, soutenant ainsi ses efforts de développement clinique en cours.
Lipella Pharmaceuticals (Nasdaq: LIPO) hat die FDA-Zulassung für ein Erweitertes Zugangsprogramm (EAP) für LP-310 erhalten, eine Mundspüllösung zur Behandlung von oralem Lichen planus (OLP). LP-310 soll gezielte Linderung bei OLP bieten, einem chronischen entzündlichen Zustand, der die Mundschleimhaut betrifft und etwa 6 Millionen Amerikaner betrifft.
Die Genehmigung des EAP ermöglicht es Patienten mit schweren oder lebensbedrohlichen Erkrankungen, auf LP-310 außerhalb von klinischen Studien vor der FDA-Zulassung zuzugreifen. Dies ist besonders bedeutsam, da es derzeit keine von der FDA genehmigten Therapien für OLP gibt, die brennende Schmerzen, weiße Flecken, geschwollenes Gewebe und offene Wunden verursacht.
Das Unternehmen betrachtet diese Genehmigung als einen entscheidenden Meilenstein bei der Lösung des unbefriedigten medizinischen Bedarfs in der OLP-Behandlung, um ihre laufenden klinischen Entwicklungsbemühungen zu unterstützen.
- FDA approval granted for Expanded Access Program for LP-310
- Addresses untapped market of 6 million Americans with OLP
- No current FDA-approved competitors in the OLP treatment space
- Expands patient access beyond Phase 2a clinical trial participants
- Product still in early clinical development (Phase 2a)
- Final FDA approval for commercial use not yet obtained
Insights
The FDA's approval of an Expanded Access Program (EAP) for LP-310 marks a strategic milestone for Lipella Pharmaceuticals, particularly significant for a company with a
First, it provides early revenue potential and real-world data collection opportunities while the Phase 2a trial is ongoing. This dual-track approach can accelerate the path to full FDA approval by generating additional safety data and clinical evidence. The approval is particularly noteworthy given the complete absence of FDA-approved therapies for oral lichen planus, which affects approximately 6 million Americans.
The strategic value extends beyond immediate patient access. LP-310's targeted oral rinse formulation addresses a key market need while potentially offering a superior safety profile through minimized systemic exposure. This local delivery approach could provide Lipella with a significant competitive advantage in the OLP market, which currently relies on off-label treatments including corticosteroids.
For investors, this development has multiple positive implications: 1) Validation of LP-310's safety profile, as EAPs typically require demonstrated safety data 2) Potential for accelerated market penetration through early physician and patient exposure 3) Opportunity for additional data collection to support future regulatory submissions. The EAP could also strengthen Lipella's position in potential partnership discussions or funding rounds.
PITTSBURGH, Feb. 06, 2025 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on developing innovative therapies for unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for an Expanded Access Program (EAP) for LP-310, an oral rinse formulation designed to treat oral lichen planus (OLP).
LP-310 is an innovative, localized therapy formulated to provide targeted relief for OLP patients while minimizing systemic exposure. Oral lichen planus is a chronic inflammatory condition affecting the mucous membranes inside the mouth, often causing burning pain, white patches, swollen tissue and open sores. The condition impacts approximately 6 million Americans and currently has no FDA-approved therapies.
Expanded Access Programs allow patients who have unmet medical needs with serious or life-threatening conditions to access treatments outside of a clinical trial that are not yet approved by the FDA.
“Receiving FDA approval for expanded use of LP-310 represents a key milestone in our mission to address the significant unmet need in oral lichen planus treatment,” said Michael Chancellor, Co-Founder and Chief Medical Officer of Lipella Pharmaceuticals. “We are pleased to make LP-310 available to patients beyond our Phase 2a clinical trial through this expanded access program. With no approved therapies currently available, this approval strengthens our commitment to advancing LP-310 as a potential solution for patients living with this painful and often debilitating condition.”
The FDA’s approval for expanded use reinforces LP-310’s potential as a new therapeutic option for OLP and supports ongoing clinical development efforts.
About LP-310
LP-310 is an oral rinse formulation of LP-10 (tacrolimus) developed to target inflammation and immune response in OLP patients. Designed for localized therapeutic effects, LP-310 minimizes systemic exposure, reducing the risks associated with long-term steroid use. A Phase 2a multicenter, dose-ranging clinical trial is currently underway to evaluate the safety, tolerability and efficacy of LP-310 in adult participants with symptomatic OLP. The trial includes three dose levels (0.25 mg, 0.5 mg and 1.0 mg of tacrolimus) and is being conducted across seven active U.S. sites, which are now recruiting participants.
About Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing innovative therapies by reformulating active agents in existing generic drugs. Lipella targets diseases with significant unmet needs, where no approved treatments currently exist.
For more information, visit lipella.com or follow us on LinkedIn and X.
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CONTACT:
Jonathan Kaufman
Chief Executive Officer
Lipella Pharmaceuticals Inc.
Info@Lipella.com
1-412-894-1853
PCG Advisory
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FAQ
What is the significance of FDA's Expanded Access Program approval for Lipella's LP-310 (LIPO)?
How many patients could potentially benefit from Lipella's LP-310 treatment?
What stage of development is Lipella's LP-310 (LIPO) currently in?
What condition does Lipella's LP-310 treat and what are its symptoms?
How does Lipella's LP-310 treatment work for OLP patients?
