Melt announces exclusive development and license pact with Catalent for Zydis

Melt Pharmaceuticals, “a clinical-stage pharmaceutical company developing novel approaches for procedural sedation,” and a former subsidiary of Harrow Health (HROW) announced it recently entered into an exclusive development and license agreement with Catalent, Under the terms of the agreement, Melt Pharmaceuticals will utilize Catalent’s proprietary Zydis orally disintegrating tablet ODT ast-dissolve technology with MELT-300, a sublingual, needle- and opioid-free patented formulation for procedural sedation during cataract surgery in the U.S. and any other countries mutually agreed upon by both parties. MELT-300, which combines fixed doses of midazolam and ketamine is administered sublingually for procedural sedation during cataract surgery and utilizes Zydis ODT technology to rapidly dissolve the tablet for absorption across the very 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,” said Larry Dillaha, M.D., CEO of Melt Pharmaceuticals. “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.” Dillaha continued, “We look forward to continuing to build our partnership with Catalent on MELT-300 through this exclusive license, which fortifies an already strong domestic and international patent portfolio. This agreement allows us, going forward, to develop, consistent with our vision, procedural sedation solutions for the approximately 100+ million annual procedures our technology may impact.” 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.