Clinical-stage pharmaceutical company Melt Pharmaceuticals Inc, a former subsidiary of Harrow Health Inc (Nasdaq:HROW), revealed on Tuesday that it has signed an exclusive development and licence agreement with contract development and manufacturing organisation (CDMO) Catalent (NYSE: CTLT).

Under this agreement Melt Pharmaceuticals will integrate Catalent's proprietary Zydis orally disintegrating tablet (ODT) fast-dissolve technology into MELT-300, a patented sublingual, needle- and opioid-free formulation for procedural sedation during cataract surgery.

MELT-300, combining a fixed dose of midazolam (3mg) and ketamine (50mg), employs 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 more than 35 FDA-approved and US-marketed products.

Larry Dillaha, M.D., CEO of Melt Pharmaceuticals, said this exclusive licence with Catalent represents a "key milestone" in the continued development of MELT-300, adding: "We believe this technology could eliminate the need for painful needle sticks in many procedures in the future."

Melt Pharmaceuticals announced previously that MELT-300 had achieved the procedural sedation primary endpoint in its Phase 2 efficacy and safety study. The company is currently in discussions with the US Food and Drug Administration (FDA) regarding Phase 3, which is expected to begin in early 2024.