Articles from Melt Pharmaceuticals, Inc.

Melt Pharmaceuticals, Inc. (“Melt”), a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced positive topline results of its pivotal Phase 3 study evaluating the safety and efficacy of its lead product candidate, MELT‑300, a non-IV, non-opioid tablet for procedural sedation during cataract surgery. Based on a Special Protocol Assessment agreement reached with the U.S. Food and Drug Administration (“FDA”) earlier this year, this study design and these positive results support the necessary objectives required for a regulatory submission.

Melt Pharmaceuticals, Inc. (“Melt”), a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced that the first patient has been dosed in its Phase 3 program evaluating the safety and efficacy of its lead product candidate, MELT-300, a non‑IV, non-opioid tablet that combines fixed doses of midazolam (3mg) and ketamine (50mg). MELT-300 is administered sublingually using Catalent Inc.’s proprietary fast‑dissolving Zydis® delivery technology to rapidly dissolve the tablet for absorption across the sublingual mucosa.

Melt Pharmaceuticals, Inc. (“Melt”), a clinical‑stage pharmaceutical company developing novel approaches for procedural sedation, today announced the completion of its Series B Preferred Stock financing of approximately $24 million from new and existing investors at a pre‑money valuation that increased nearly 150% from the pre-money valuation for Melt’s Series A Preferred Stock financing in 2019. The capital raised will primarily support the further development of MELT-300, including the MELT-300 Phase 3 program. MELT-300, a non-IV, non‑opioid tablet that combines fixed doses of midazolam (3mg) and ketamine (50mg), is administered sublingually using Catalent Inc.’s proprietary fast‑dissolving Zydis® delivery technology to rapidly dissolve the tablet for absorption across the very thin sublingual mucosa. The MELT-300 Phase 3 program commenced in the first quarter of 2024, with first patient dosing expected in the second quarter of 2024 and a topline readout expected in the fourth quarter of 2024.

Melt Pharmaceuticals, Inc. (“Melt”), a clinical‑stage pharmaceutical company developing novel approaches for procedural sedation, today provided a corporate update. The Company previously announced that MELT-300 achieved the primary sedation endpoint in its Phase 2 Pivotal Efficacy and Safety Study in subjects undergoing cataract surgery. MELT‑300, a non-IV, non-opioid tablet that combines fixed doses of midazolam (3mg) and ketamine (50mg), is administered sublingually using Catalent Inc.’s proprietary fast‑dissolving Zydis® delivery technology to rapidly dissolve the tablet for absorption across the very thin sublingual mucosa.

Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced it recently entered into an exclusive development and license agreement with Catalent, the global leader in enabling the development and supply of better treatments across multiple modalities.

Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced top-line results of its Phase 2 pivotal efficacy and safety study for its lead product candidate, MELT-300, a sublingual, needle- and opioid-free patented formulation for procedural sedation during cataract surgery. Based on the outcome of the MELT-300 data, the company intends to request a meeting with the U.S. Food and Drug Administration (FDA) to discuss the results of this study and the continued clinical development of MELT-300.

Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel approaches for procedural sedation and analgesia, today announced the dosing of the last patient in its Phase 2 pivotal efficacy and safety study for its lead product candidate, MELT-300, a sublingual, needle- and opioid-free patented formulation for procedural sedation and analgesia during cataract surgery. Top-line results from this study are expected before the end of the year.

Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel approaches for procedural sedation and analgesia, today announced top-line results of its phase 1 pharmacokinetics (PK) study of MELT-210. MELT-210 is a fixed dose of 3 mg of midazolam formulated in a proprietary rapidly dissolving sublingual tablet technology for procedural sedation.

Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing first‑in‑class medicines for sedation and analgesia, today announced the filing of two investigational new drug applications (INDs) with the U.S. Food and Drug Administration (FDA) for two sublingual, IV-free, non‑opioid formulations – MELT-210 (midazolam) for procedural sedation and MELT-400 (ketamine) for pain. Both formulations have been developed in an exclusive partnership with Catalent (NYSECTLT) using its proprietary Zydis® orally disintegrating tablet (ODT) technology, which is currently used in 35 products.