Melt Pharmaceuticals Provides Corporate Update
January 03 2024 - 7:15AM
Business Wire
Melt Pharmaceuticals, Inc. (“Melt”), a clinical‑stage
pharmaceutical company developing novel approaches for procedural
sedation, today provided a corporate update. The Company previously
announced that MELT-300 achieved the primary sedation endpoint in
its Phase 2 Pivotal Efficacy and Safety Study in subjects
undergoing cataract surgery. MELT‑300, a non-IV, non-opioid tablet
that combines fixed doses of midazolam (3mg) and ketamine (50mg),
is administered sublingually using Catalent Inc.’s proprietary
fast‑dissolving Zydis® delivery technology to rapidly dissolve the
tablet for absorption across the very thin sublingual mucosa.
Melt Pharmaceuticals recently received a written response from
the U.S. Food and Drug Administration (FDA) regarding its planned
MELT-300 Phase 3 program. Based on the FDA’s response, Melt
Pharmaceuticals expects to begin Phase 3 program activities, which
will consist of a single pivotal study comparing MELT-300 to
sublingual midazolam and placebo in subjects undergoing cataract
surgery, in the first quarter of 2024.
Additionally, Melt has now reached an agreement with and paid in
full all the outstanding principal and accrued and unpaid interest
under its loan facility with Harrow, Inc. (Nasdaq: HROW), Melt’s
largest shareholder, through the issuance of shares of Melt’s
Series B and Series B-1 Preferred Stock. Following this
transaction, in addition to certain royalty rights, Harrow’s equity
ownership percentage of Melt is approximately 47%.
“We are very pleased to have received a response from the FDA
that supports the investment we are making in our proposed MELT‑300
Phase 3 program,” said Dr. Dillaha. “This was the last step needed
to finalize our program design, paving the way for the commencement
of Phase 3 program activities in early 2024. Following the debt
settlement with Harrow and our successful efforts to date to secure
sufficient funding to commence the Phase 3 program, we can now
focus on the advancement of our non-IV, non‑opioid MELT-300 product
candidate, which we believe has the potential to revolutionize
short‑duration procedural sedation for more than 100 million U.S.
medical procedures, enhancing the surgical patient experience by
providing greater comfort and reducing reliance on opioids.”
About Melt Pharmaceuticals
Melt Pharmaceuticals, Inc. is a clinical-stage pharmaceutical
company focused on developing proprietary non-opioid, non-IV,
sedation, and analgesia therapeutics for human medical procedures
in the hospital, outpatient, and in-office settings. Melt intends
to seek regulatory approval through the FDA’s 505(b)(2) regulatory
pathway for its proprietary, patented small-molecule product
candidates, where possible. Melt’s core intellectual property is
the subject of multiple granted patents in North America, Europe,
Asia, and the Middle East. Melt Pharmaceuticals, Inc. is a former
subsidiary of Harrow, Inc. (Nasdaq: HROW) and was carved out as a
separately managed business in 2019. To learn more about Melt,
please visit their website, www.meltpharma.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20240103707106/en/
Investor Contact: Larry Dillaha, M.D. Chief Executive
Officer ldillaha@meltpharma.com
Media Contact: Deb Holliday Holliday Communications, Inc.
deb@hollidaycommunications.net 412-877-4519
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