Melt Pharmaceuticals’ MELT-300 (Midazolam 3mg and Ketamine 50mg Sublingual Tablet) Achieves Primary Sedation Endpoint in Phase 2 Pivotal Efficacy and Safety Study
December 21 2022 - 8:21AM
Business Wire
MELT-300 Statistically Superior for
Procedural Sedation Compared to All Comparator Treatment Arms,
Including Midazolam 3mg (P=0.0129) and Ketamine 50mg
(P=0.0096)
MELT-300 Treatment Arm 50% Less Likely to
Require Rescue Sedation Compared to Midazolam
(P=0.0198)
MELT-300 Treatment Arm 66% Less Likely to
Require Rescue Sedation Pre-Operatively Compared to the
Midazolam Treatment Arm
MELT-300 Had a Favorable Safety Profile That
Was Generally Comparable to Placebo
Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical
company developing novel approaches for procedural sedation, today
announced top-line results of its Phase 2 pivotal efficacy and
safety study for its lead product candidate, MELT-300, a
sublingual, needle- and opioid-free patented formulation for
procedural sedation during cataract surgery. Based on the outcome
of the MELT-300 data, the company intends to request a meeting with
the U.S. Food and Drug Administration (FDA) to discuss the results
of this study and the continued clinical development of
MELT-300.
MELT-300 combines fixed doses of midazolam (3mg) and ketamine
(50mg) in one rapidly dissolving tablet (RDT) that is administered
sublingually for procedural sedation during cataract surgery.
MELT‑300 utilizes Catalent Inc.’s proprietary fast-dissolving
Zydis® delivery technology to rapidly dissolve the tablet for
absorption across the very thin sublingual mucosa.
The factorial-designed, randomized, double-blind,
placebo-controlled, parallel-cohort Phase 2 study was designed to
evaluate the efficacy and safety of MELT-300 and the contribution
of midazolam and ketamine components to sedation and intraoperative
ocular analgesia in subjects undergoing cataract surgery. The trial
compared MELT-300 against (i) placebo alone, (ii) sublingually
delivered midazolam alone, and (iii) sublingually delivered
ketamine alone, with two independent primary efficacy endpoints:
(a) appropriate cataract surgery sedation using a validated
sedation scale (Ramsay Sedation Scale), or (b) the management of
intraoperative pain during the cataract surgery. The study was
conducted at nine sites and enrolled over 300 subjects.
“We are extremely pleased with the robust sedation efficacy from
our pivotal Phase 2 study of MELT-300,” said Larry Dillaha, M.D.,
CEO of Melt Pharmaceuticals. “The clear, critical, and positive
findings for our procedural sedation primary endpoint allow us to
confidently proceed with the development of this non-IV option for
cataract surgery. We believe the commercial appeal for offering
patients and physicians the ability to achieve adequate sedation
without the need to start an IV is an extremely attractive option
for the nearly 5 million cataract surgeries performed every year in
the U.S. and the more than 20 million cataract surgeries performed
around the world each year.”
MELT-300 co-inventor, Melt Pharmaceuticals board member, and
ophthalmologist John Berdahl, M.D., commented, “The MELT-300 data
for procedural sedation is extraordinary and promises to catalyze a
shift in the sedation paradigm for cataract surgery in the United
States and around the world. In particular, the data demonstrating
that pre-operative sublingual administration of MELT-300 was
superior to midazolam has important implications for the daily
workflow of the surgical team and most importantly the patient
experience. I am excited beyond measure to see MELT-300 advance
and, in time, become a candidate for FDA approval.”
Dr. Dillaha continued, “We intend to leverage the demonstrable
synergy between the components of MELT-300 to fortify an already
strong domestic and international patent portfolio so that in the
future, we can develop, consistent with our vision, procedural
sedation solutions for the approximately 100+ million annual
procedures our technology may impact.”
About Melt Pharmaceuticals
Melt Pharmaceuticals, Inc. is a clinical-stage pharmaceutical
company focused on the development and commercialization of
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. was founded in 2019 by
Harrow Health, Inc. (Nasdaq: HROW), which currently owns 46%
of Melt, along with a 5% royalty on the MELT-300 drug candidate. 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/20221221005126/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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