Melt Pharmaceuticals Announces First Patient Dosed in Pivotal Phase 3 Program of Its Lead Product Candidate, MELT-300, for Needle- and Opioid-Free Sedation in Patients Undergoing Cataract Surgery
Melt Pharmaceuticals Closes $24 Million Series B Preferred Stock Financing
Melt Pharmaceuticals Provides Corporate Update
Melt Pharmaceuticals Announces Exclusive Development and License Agreement with Catalent for Its Zydis® Fast-Dissolve Technology for Use in MELT-300 for Needle- and Opioid-Free Procedural Sedation
NASHVILLE, Tenn.--(BUSINESS WIRE)--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.
NASHVILLE, Tenn.--(BUSINESS WIRE)--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.
NASHVILLE, Tenn.--(BUSINESS WIRE)--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.
NASHVILLE, Tenn.--(BUSINESS WIRE)--Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing first?in?class medicines for sedation and analgesia, today announced the addition of Brad Osborne as Chief Financial Officer. Osborne brings 20 years of extensive finance and accounting experience.
NASHVILLE, Tenn.--(BUSINESS WIRE)--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 (NYSE: CTLT) using its proprietary Zydis® orally disintegrating tablet (ODT) technology, which is currently used in 35 products.
NASHVILLE, Tenn.--(BUSINESS WIRE)--Harrow Health, Inc. (Nasdaq: HROW), an ophthalmic-focused healthcare company, and Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing first-in-class medicines for sedation and analgesia, today announced that Harrow Health has provided a $13.5 million senior secured loan to Melt Pharmaceuticals.