Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 160

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 160
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 administration. Mupirocin is currently approved in the U.S. as a topical antibiotic
(Bactroban) but is unsuitable for systemic use due to rapid metabolism and high protein binding..

Nano-Mupirocin is a novel liposomal formulation
being developed to enable parenteral administration of mupirocin (i.e., administration into the body by routes other than the intestines
or digestive tract), with the goal of evaluating its potential as a systemically active antibiotic. By encapsulating mupirocin in a liposomal
composition similar to that used in the FDA-approved product Doxil (liposomal doxorubicin), preclinical studies suggest that the drug
may be protected in the bloodstream and may exhibit altered bioavailability and antibacterial activity against serious and resistant
bacterial pathogens identified by the CDC. However, these observations are limited to preclinical models, and there can be no assurance
that such effects will be observed in humans, that they will result in clinical benefit, or that they will be sufficient for regulatory
approval..

While no assurance can be provided, we believe
that the 505(b)(2) pathway may provide an appropriate regulatory approach for this product, subject to FDA discretion, as it could allow
us to bridge existing data on both the active ingredient (mupirocin) and the well-characterized and FDA-approved liposomal delivery platform,
while generating new data specific to the systemic application of the formulation. This regulatory strategy may provide a scientifically
sound and capital-efficient path to approval and could potentially facilitate development of a critical new therapeutic in the context
of the growing global threat of antimicrobial resistance.

We believe that the 505(b)(2) pathway may
be appropriate, subject to FDA discretion, as it could allow the sponsor to reference existing safety and efficacy data on mupirocin
from prior approvals and published literature, while requiring new data to bridge the change in formulation, route of administration,
and indication. The 505(b)(2) application may rely in part on existing data for the known active ingredient, mupirocin, from the Reference
Listed Drug (Bactroban, GSK). If accepted by the FDA, this approach may enable us to leverage available data on mupirocin, including
toxicological and efficacy data from studies previously conducted by other sponsors. If permitted, this pathway could potentially offer
a more efficient and capital-sparing route to approval compared to traditional development pathways, such as 505(b)(1). While