Our Science

Lead Drug Candidate

Melt-300

Our lead program, Melt-300, is a fast dissolving, patented sublingual tablet that provides needle- and opioid-free procedural sedation during cataract surgery — a growing field with significant market opportunity. Melt-300 combines 3 mg midazolam and 50 mg ketamine, two drugs with a long history of use, into a single, rapidly dissolving tablet. Melt-300 is manufactured using Catalent, Inc.’s patented fast-dissolving Zydis® technology. Sublingual delivery allows for rapid absorption into the central circulation, avoiding first-pass metabolism required for oral medications.

We are seeking approval through the 505(b)2 regulatory pathway and expect to report top-line results from our Phase 2 clinical trial by the end of 2022.

Sublingual Mouth

IV line

Benefits For Patients and Healthcare Providers

  • ‘Pain free’ sedation – no IV line insertion
  • No needle stick or bruising
  • Opioid-free
  • Sublingual delivery provides rapid absorption
  • Reduce time for staff, increase operational efficiency
  • Potential to use across a wide range of patients, including geriatric, and those with a phobia to needles.

According to 2021 published data, a group from Duke University performed a two-year single-center retrospective study of over 2,000 patients (making up over 3,000 cases) undergoing routine cataract surgery and found that approximately 97% of the cases received at least one dose of the opioid fentanyl.1

With nothing like it currently in development, Melt-300 has the potential to replace IV administered sedation in millions of procedures.

Other Product Candidates

Melt-210

Melt-210 provides 3 mg of midazolam in one sublingual tablet for procedural sedation for panic attacks and other acute anxiety conditions. Melt-210 is also manufactured using Catalent, Inc.’s patented fast-dissolving Zydis® technology. We completed our Phase 1 clinical trial in 2022 and the top-line data met the goals of the study.

Melt-400

Melt-400 provides 50 mg of ketamine in one sublingual tablet for acute mild-to-moderate pain management. Melt-400 is also manufactured using Catalent, Inc.’s patented fast-dissolving Zydis® technology. We have an open Investigational New Drug Application (IND) for Melt-400.

What People Are Saying

“I have used the MKO Melt as a patient and as the surgeon. As a patient, I was grateful to avoid the IV stick. As a surgeon, avoiding opioids while getting great sedation is wonderful.”

Mike Greenwood, MD refers to his experience with MKO Melt, a compounded version similar to Melt-300

References

  1. Davidson, Donaldson, et al., Persistent Opioid Use in Cataract Surgery Pain Management and the Role of Non-Opioid Alternatives, https://read.qxmd.com/read/34753878/persistent-opioid-use-in-cataract-surgery-pain-management-and-the-role-of-non-opioid-alternatives (2021)
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