Just over a month since sharing plans to purchase Melt Pharmaceuticals, Inc., Harrow announced it has officially sealed the deal on its acquisition.
Or, rather, its reacquisition of its former subsidiary.
First things first: Do we know how much this deal was worth?
Unfortunately, that information was not publicly shared.
I had to ask. Now let’s get to Melt.
We won’t get into the nitty gritty details on the clinical-stage pharmaceutical company (see here for our full rundown) this time around.
Instead, we’ll focus on the main reason for Harrow wanting to re-integrate Melt into its company:
- MELT-300, a non-intravenous (IV) and non-opioid tablet intended for procedural sedation during cataract surgery (as well as potentially a wide range of other office-based and outpatient procedures).
Talk about this tablet.
MELT-300 is part of Melt’s pipeline of product candidates—which also includes MELT-210 and MELT-400—based on the proprietary Zydis oral dissolving tablet (ODT) drug delivery system.
- How the system works: A freeze-dried tablet is dissolved and absorbed almost instantly when delivered sublingually—without the need for water.
As for MELT-300: The tablet encompasses a patented formulation of a fixed dose of midazolam (3 mg) and ketamine (50 mg).
How far along in the clinical process is it?
See here for a recap of its favorable phase 3 clinical performance from the Lower Opioid Use and Improve the Sedation Experience (LOUISE) study. And click here for a more detailed look.
- Let’s also take note: That study was conducted with an FDA-supported special protocol assessment (SPA)—and its design was confirmed to "adequately support a future regulatory submission.”
Got it. So why did Harrow want to acquire this tablet?
MELT-300 (and the other candidates in Melt’s pipeline) represents a “strategic expansion” of Harrow’s current portfolio
Case in point: The company already owns (via its subsidiary ImprimisRx) MKO Melt, a compounded sublingual sedation tablet primarily used for cataract surgery.
- As such: Harrow noted that MELT-300 has the potential to become MKO Melt’s “FDA-approved successor.”
Wait … what’s the difference between the two?
The tablets’ formulations.
As we mentioned, MELT-300 encompasses a fixed dose of midazolam (3 mg) and ketamine (50 mg).
- Comparatively: MKO Melt is composed of midazolam (3 mg), ketamine hydrochloride (HCl; 25 mg), and ondansetron (2 mg).
And while both tablets feature midazolam in their formulation: Harrow noted that phase 2 and 3 clinical programs found MELT-300 demonstrated “statistically superiority to midazolam alone.”
Alrighty, so what’s next for this investigational tablet?
Harrow has big plans to integrate and accelerate MELT-300’s clinical progress toward a new drug application (NDA) submission, eventual FDA approval, and—end game goal here—U.S. commercial market launch.
But first up: The company will be initiating one non-clinical animal study and three pharmacokinetic (PK) studies on the tablet to support data needed for an NDA package.
And the timeframe for that?
Pending all goes according to plan, Harrow estimated the following:
- NDA submission to the FDA by the first half (H1) of 2027
- Regulatory review and FDA approval by H1 2028
- Commercial launch by H2 2028 followed by market expansion
See here for a more detailed look at these plans.
And beyond MELT-300—does Harrow have plans for Melt’s other candidates?
Indeed, it does, starting with MELT-210.
Also under clinical development for procedural sedation, MELT-210 is a sublingual dosage of midazolam (3 mg) administered via the same Zydis ODT system.
- Its clinical journey thus far: Has involved phase 2 and phase 3 trials as a comparator drug in MELT-300’s clinical program, demonstrating a rapid intake and short half-life.
And the plan?
Noting its “strong commercial potential,” Harrow intends to meet with the FDA to discuss next steps for this advanced drug development program, with the long-term intention of adding a second product from the Melt portfolio to the U.S. market.
As always, stay tuned for updates on this!