Melt Pharmaceuticals Reports Positive Phase 3 Topline Efficacy Results for MELT-300, Its Lead Product Candidate for Opioid-Free, Sublingual Procedural Sedation in Patients Undergoing Catar...
Catalent, Inc. (CTLT)
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Source: Yahoo! Finance
Proportion of Patients Requiring Rescue Sedation Was Nearly Two-Fold Higher for Sublingual Midazolam Compared with MELT-300 (P=0.003) MELT-300 Had a Favorable Safety Profile That Was Generally Comparable to Placebo NASHVILLE, Tenn., November 20, 2024 BUSINESS WIRE )--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-300 uniquely combines a fixed dose of midazolam (3mg) and ketamine (50mg) in one tablet that is administered sublingually u
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CTLT
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- 8/29/24 - Miss
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- 12/18/24 - Form 4
- 12/18/24 - Form 4
- 12/18/24 - Form 4
- CTLT's page on the SEC website