Mich., May 12, 2022 /PRNewswire/ -- Rockwell
Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company dedicated
to transforming the treatment of iron deficiency and anemia
management, today announced that it provided the U.S. Food and
Drug Administration (FDA) with the supplemental data, requested by
the agency in December 2021, for the
Company's pending Investigational New Drug (IND) application in
support of a proposed Phase 2 clinical trial of Ferric
Pyrophosphate Citrate (FPC) for the treatment of iron deficiency
anemia and maintenance of hemoglobin in patients receiving infusion
therapy in the home setting. The additional data relate to the
physical, chemical and microbiological stability of FPC in support
of the suggested method of administration in the Phase 2 protocol.
Home Infusion, where various medications are given via infusion
therapy in the home, rather than an infusion center, is a
rapidly-growing segment of home healthcare. Many patients
that are receiving infusion therapy at home suffer from diseases
that are associated with iron deficiency, which is difficult to
treat with traditional forms of iron.
"We are pleased to provide the FDA with the additional
data it requested to support our IND for FPC in patients undergoing
infusion therapy at home," said Russell
Ellison, M.D., M.Sc., President and CEO of Rockwell Medical.
"This is an iterative process with the FDA as this is the first
clinical trial of parenteral iron in the treatment of iron
deficiency anemia in the home setting, with the goal of enabling
patients to avoid visits to a doctor's office or clinic to receive
iron, which would represent a significant improvement in the care
of these patients. We remain confident in the potential of FPC and
are prepared to move forward with the initiation of the Phase 2
trial, pending the review and clearance of our IND"
The FDA has 30 days to review the additional data that have been
submitted. In the event that the FDA has no further questions or
requirements regarding the submission, the Company would expect the
trial to start shortly after the review period ends.
About Rockwell Medical
Rockwell Medical is a
commercial-stage biopharmaceutical company developing and
commercializing its next-generation parenteral iron technology
platform, Ferric Pyrophosphate Citrate (FPC), which has the
potential to lead transformative treatments for iron deficiency in
multiple disease states, reduce healthcare costs and improve
patients' lives. The Company has two FDA-approved therapies
indicated for patients undergoing hemodialysis, which are the first
two products developed from the FPC platform. Rockwell
Medical is also advancing its FPC platform by developing FPC
for the treatment of iron deficiency anemia in patients outside of
dialysis, who are receiving intravenous medications in the home
infusion setting. In addition, Rockwell Medical is one of
two major suppliers of life-saving hemodialysis concentrate
products to kidney dialysis clinics in the United States. For more information,
About Home Health and IDA in Home Infusion
Home health is an area of medicine experiencing
explosive growth – a trend that will likely continue over the next
decade due to an aging US population, the need to control costs,
the desire to improve patient outcomes, and the convenience of home
Home infusion therapy, an important part of some home care
regimens, allows patients with diseases requiring regular infusions
of intravenous medications to be treated in the comfort of their
home and has been proven to be a cost-effective, safe, and
efficacious alternative to inpatient care for a variety of
therapies and disease states, both acute and chronic.
Treating IDA as part of an existing home infusion regimen more
effectively, calls for an innovative approach. Rockwell Medical is
developing a technology to manage iron in the home infusion
setting. Ferric Pyrophosphate Citrate (FPC) is Rockwell's novel
next-generation parenteral iron is anticipated to enter a Phase II
study for the treatment of IDA in the home infusion setting in the
first half of the year.
Certain statements in this
press release may constitute "forward-looking statements" within
the meaning of the federal securities laws. Words such as, "may,"
"might," "will," "should," "believe," "expect," "anticipate,"
"estimate," "continue," "could," "can," "would," "develop," "plan,"
"potential," "predict," "forecast," "project," "intend" or the
negative of these terms, and similar expressions, or statements
regarding intent, belief, or current expectations, are forward
looking statements. While Rockwell Medical believes these
forward-looking statements are reasonable, undue reliance should
not be placed on any such forward-looking statements, which are
based on information available to us on the date of this release.
These forward-looking statements are based upon current estimates
and assumptions and are subject to various risks and uncertainties
(including, without limitation, those set forth in Rockwell
Medical's SEC filings), many of which are beyond our
control and subject to change. Actual results could be materially
different. Risks and uncertainties include, but are not limited to
those risks more fully discussed in the "Risk Factors" section of
our Annual Report on Form 10-K for the year ended December 31,
2021, as such description may be amended or updated in any future
reports we file with the SEC. Rockwell
Medical expressly disclaims any obligation to update our
forward-looking statements, except as may be required by law.
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SOURCE Rockwell Medical Technologies, Inc.