Melt Pharmaceuticals Announces Dosing of Last Patient in Phase 2 Pivotal Efficacy and Safety Study for MELT-300
October 27 2022 - 8:00AM
Business Wire
Top-Line Results Expected by
Year-End
Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical
company developing novel approaches for procedural sedation and
analgesia, today announced the dosing of the last patient in 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 and analgesia during cataract
surgery. Top-line results from this study are expected before the
end of the year.
MELT-300 combines fixed doses of midazolam (3mg) and ketamine
(50mg) in one dissolvable tablet that is administered sublingually
for procedural sedation and analgesia during cataract surgery. This
product candidate utilizes Catalent’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 extraction with
lens replacement (CELR). The trial compared MELT-300 against (i)
placebo alone, (ii) sublingually delivered midazolam alone, and
(iii) sublingually delivered ketamine alone, with the primary
efficacy endpoints of appropriate sedation during the cataract
surgery and management of intraoperative pain during the surgery.
The study was conducted at nine sites and enrolled over 330
subjects.
“With the dosing of the last patient in our MELT-300 Phase 2
study, we anticipate reporting top-line results by the end of 2022,
representing a significant step forward towards the achievement of
our mission to provide procedural sedation and analgesia that is
needle- and opioid-free, enhancing the patient experience and their
clinical outcome,” said Larry Dillaha, M.D., CEO of Melt
Pharmaceuticals. “We are grateful to the investigators and patients
who have participated in this pivotal efficacy and safety study,
which, to our knowledge, is the first serious attempt to advance
the standard of anesthesia care for the nearly 5 million Americans
each year who undergo cataract surgery. We are excited to learn and
share the findings of the MELT-300 study, and, if the study is
successful, we look forward to discussing with the U.S. Food and
Drug Administration (FDA) the study results and next steps in the
continued development of MELT-300 and its components as a needle-
and opioid-free option for sedation and analgesia.”
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 hospital, outpatient and in-office
settings. Melt intends to seek regulatory approval through the
FDA’s 505(b)(2) regulatory pathway for these proprietary, patented
small-molecule product candidates, where possible. The core IP that
Melt owns is a patented series of combination non-opioid sedation
drug formulations that Melt believes has multiple clinical
applications for potential indications of use. Melt
Pharmaceuticals, Inc. is a former subsidiary of Harrow Health, 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/20221027005245/en/
Investor Contact: Larry Dillaha, M.D. Chief Executive
Officer ldillaha@meltpharma.com
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