LEAD DRUG CANDIDATE: MELT-100
Our lead program, Melt-100, is a sublingual, needle and opioid-free patented formulation for procedural sedation and analgesia during cataract surgery — a growing field with significant market opportunity. Melt-100 combines 3 mg midazolam and 25 mg ketamine, two drugs with a long history of use, into a single, rapidly dissolving tablet. Melt-100 is manufactured using 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 begin Phase 1 testing during the second half of 2020.
BENEFITS FOR PATIENTS AND
- ‘Pain free’ sedation – no IV line insertion
- No needle stick or bruising
- Sublingual delivery provides rapid absorption
- Reduce time for staff, increase operational efficiency
- Potential to use across a wide range of patients, including pediatric, geriatric, and those with a phobia to needles.
Results from a recent survey with Ophthalmic Anesthesia Society (OAS) indicate use of opioids (e.g. fentanyl) prior to and during cataract surgery is common practice.1
- 30% of patients given opioids pre-operatively for procedural sedation and analgesia in cataract surgery
- Over 50% patients given opioid at some point during cataract surgical procedure
With nothing like it currently in development, Melt-100 has the potential to replace IV administered sedation in millions of procedures.
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-100
- Recent results from Ophthalmology Anesthesiology Society (OAS) survey in cataract surgery (2020).