Melt Pharmaceuticals Announces Dosing of Last Patient in Pivotal Phase 3 Study of Its Lead Product Candidate, MELT-300, for Needle- and Opioid-Free Sedation in Patients Undergoing Cataract...
Harrow, Inc. (HROW)
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Source: Business Wire
Topline Readout Expected in Q4 2024FDA Agrees to a MELT-300 Phase 3 Special Protocol Assessment NASHVILLE, Tenn.--(BUSINESS WIRE)--Melt Pharmaceuticals, Inc. (“Melt”), a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced the dosing of the last patient in 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.MELT-300 combines fixed doses of midazolam (3mg) and ketamine (50mg) in one tablet that is administered sublingually using Catalent’s proprietary Zydis® delivery technology to dissolve and absorb the active ingredients across the sublingual mucosa rapidly. The MELT-300 Phase 3 clinical trial is a randomized, double-blind, three-arm study comparing, at a 4:1:1 ratio, MELT-300, sublingual midazolam, and sublingual placebo, respectively, for procedural sedation. The study was conducted at 13 clinical site
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- 11/13/24 - Miss
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- 10/28/24 - Form 8-K
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