Melt Pharmaceuticals Announces Development and License Agreement with Catalent for Its Zydis Fast-Dissolve Technology

Melt Pharmaceuticals, a former subsidiary of Harrow Health, announced it has entered into an exclusive development and license agreement with Catalent in which Melt will utilize Catalent’s proprietary Zydis orally disintegrating tablet (ODT) fast-dissolve technology with MELT-300, a sublingual, needle- and opioid-free patented formulation for procedural sedation during cataract surgery.

MELT-300, which combines fixed doses of midazolam (3mg) and ketamine (50mg), is administered sublingually for procedural sedation during cataract surgery and utilizes Zydis ODT technology to rapidly dissolve the tablet for absorption across the thin sublingual mucosa. Catalent’s Zydis ODT technology is currently used in over 35 FDA-approved and U.S.-marketed products.

“This exclusive license with Catalent is a key milestone for the continued development of MELT-300,” Larry Dillaha, MD, CEO of Melt Pharmaceuticals, said in a company news release. “We chose Catalent’s Zydis delivery technology because it is a proven fast-dissolving technology, and with the Zydis technology, our product candidate dissolves in a matter of seconds and begins to be absorbed across the sublingual mucosa. We believe this technology could eliminate the need for painful needle sticks in many procedures in the future.”

Melt Pharmaceuticals previously announced that MELT-300 achieved the procedural sedation primary endpoint in its phase 2 efficacy and safety study. Melt Pharmaceuticals is currently in discussions with the FDA on the phase 3 program, which Melt expects to begin in early 2024.