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...
Harrow, Inc. (HROW)
Last harrow, inc. earnings: 11/13 04:21 pm
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Source: Business Wire
MELT-300 Demonstrates Statistically Superior Compared to Both Sublingual Midazolam (P=0.009) and Placebo (PProportion 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.--(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 mi
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HROW
Earnings
- 11/13/24 - Miss
HROW
Sec Filings
- 11/14/24 - Form 10-Q
- 11/14/24 - Form 8-K
- 10/28/24 - Form 8-K
- HROW's page on the SEC website