midazolam/ketamine sublingual tablet (MELT-300) / Melt Pharma - LARVOL DELTA

Harrow Announces Closing of Acquisition of Melt Pharmaceuticals (Harrow) - "Harrow...announced that it has completed the acquisition of Melt Pharmaceuticals, Inc. (Melt), a clinical-stage pharmaceutical company pioneering non-opioid, non-IV therapies for sedation for medical procedures in the hospital, outpatient, and in-office settings. Melt’s product candidates, MELT-210, MELT-300, and MELT-400, are based on the proprietary Zydis ODT (oral dissolving tablet) drug delivery platform."

M&A • Pain

A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR) (clinicaltrials.gov) - P3 | N=486 | Recruiting | Sponsor: Melt Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Anesthesia • Cataract • Ophthalmology

A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR) (clinicaltrials.gov) - P3 | N=486 | Not yet recruiting | Sponsor: Melt Pharmaceuticals

New P3 trial • Anesthesia • Cataract • Ophthalmology

A Study of MELT-300 (Midazolam and Ketamine Sublingual Tablets) for Sedation and Intraoperative Ocular Analgesia in Participants Undergoing Cataract Extraction With Lens Replacement (CELR) (clinicaltrials.gov) - P2 | N=338 | Completed | Sponsor: Melt Pharmaceuticals | Recruiting ➔ Completed

Trial completion • Anesthesia • Cataract • Ophthalmology

A Study of MELT-300 (Midazolam and Ketamine Sublingual Tablets) for Sedation and Intraoperative Ocular Analgesia in Participants Undergoing Cataract Extraction With Lens Replacement (CELR) (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Melt Pharmaceuticals | Trial completion date: May 2022 ➔ Oct 2022 | Trial primary completion date: Mar 2022 ➔ Sep 2022

Trial completion date • Trial primary completion date • Anesthesia • Cataract • Ophthalmology

A Study of MELT-300 (Midazolam and Ketamine Sublingual Tablets) for Sedation and Intraoperative Ocular Analgesia in Participants Undergoing Cataract Extraction With Lens Replacement (CELR) (clinicaltrials.gov) - P2; N=300; Recruiting; Sponsor: Melt Pharmaceuticals; Not yet recruiting ➔ Recruiting; Trial completion date: Dec 2021 ➔ May 2022; Initiation date: Nov 2021 ➔ Jul 2021; Trial primary completion date: Dec 2021 ➔ Mar 2022

Clinical • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Anesthesia • Cataract • Ophthalmology

A Study of MELT-300 (Midazolam and Ketamine Sublingual Tablets) for Sedation and Intraoperative Ocular Analgesia in Participants Undergoing Cataract Extraction With Lens Replacement (CELR) (clinicaltrials.gov) - P2; N=300; Not yet recruiting; Sponsor: Melt Pharmaceuticals

Clinical • New P2 trial • Anesthesia • Cataract • Ophthalmology

Phase 1 Bioavailability Study of MELT-100 (Midazolam and Ketamine Sublingual) and IV Midazolam or Ketamine (clinicaltrials.gov) - P1; N=17; Completed; Sponsor: Melt Pharmaceuticals; Not yet recruiting ➔ Completed

Clinical • Trial completion

Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine (clinicaltrials.gov) - P1; N=25; Completed; Sponsor: Melt Pharmaceuticals

Clinical • New P1 trial • Anesthesia