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 Cataract Surgery
Melt Pharmaceuticals announced positive Phase 3 topline results for MELT-300, a non-IV, non-opioid sublingual tablet for procedural sedation during cataract surgery. The study, involving over 530 patients across 13 U.S. clinical sites, demonstrated MELT-300's statistical superiority over both sublingual midazolam (P=0.009) and placebo (P<0.001). The tablet combines midazolam (3mg) and ketamine (50mg), dissolving in 3 seconds using Catalent's Zydis® technology. Patients receiving midazolam alone required nearly twice the rescue sedation compared to MELT-300 (P=0.003), while MELT-300 showed a favorable safety profile comparable to placebo.
Melt Pharmaceuticals ha annunciato risultati positivi provvisori della Fase 3 per MELT-300, una compressa sublinguale non IV e non oppioide per la sedazione durante interventi chirurgici di cataratta. Lo studio, che ha coinvolto oltre 530 pazienti in 13 siti clinici negli Stati Uniti, ha dimostrato la superiorità statistica di MELT-300 sia rispetto al midazolam sublinguale (P=0.009) che al placebo (P<0.001). La compressa combina midazolam (3mg) e ketamina (50mg), sciogliendosi in 3 secondi utilizzando la tecnologia Zydis® di Catalent. I pazienti che ricevevano solo midazolam necessitavano di quasi il doppio della sedazione di soccorso rispetto a MELT-300 (P=0.003), mentre MELT-300 ha mostrato un profilo di sicurezza favorevole comparabile a quello del placebo.
Melt Pharmaceuticals anunció resultados positivos preliminares de la Fase 3 para MELT-300, una tableta sublingual no IV y no opioide para la sedación durante la cirugía de cataratas. El estudio, que involucró a más de 530 pacientes en 13 sitios clínicos en EE. UU., demostró la superioridad estadística de MELT-300 tanto sobre el midazolam sublingual (P=0.009) como sobre el placebo (P<0.001). La tableta combina midazolam (3mg) y ketamina (50mg), disolviéndose en 3 segundos utilizando la tecnología Zydis® de Catalent. Los pacientes que recibieron solo midazolam necesitaron casi el doble de sedación de rescate en comparación con MELT-300 (P=0.003), mientras que MELT-300 mostró un perfil de seguridad favorable comparable al del placebo.
Melt Pharmaceuticals는 백내장 수술 중 시술 진정을 위한 비정맥 주사, 비오피오이드 설하 정제인 MELT-300의 긍정적인 3상 초기 결과를 발표했습니다. 이 연구는 미국의 13개 임상 사이트에서 530명 이상의 환자를 포함했으며, MELT-300이 설하 미다졸람(P=0.009) 및 위약(P<0.001)보다 통계적으로 우수함을 보여주었습니다. 이 정제는 미다졸람(3mg)과 케타민(50mg)을 혼합하여, Catalent의 Zydis® 기술을 사용해 3초 만에 용해됩니다. 미다졸람만 투여받은 환자는 MELT-300에 비해 거의 두 배에 해당하는 구조적인 진정이 필요했으며(P=0.003), MELT-300은 위약과 비교해도 우수한 안전성 프로필을 보였습니다.
Melt Pharmaceuticals a annoncé des résultats préliminaires positifs de la Phase 3 pour MELT-300, un comprimé sublingual non IV et non opioïde pour la sédation procédurale lors de la chirurgie de la cataracte. L'étude, qui a impliqué plus de 530 patients dans 13 sites cliniques aux États-Unis, a démontré la supériorité statistique de MELT-300 par rapport à la midazolam sublinguale (P=0.009) et au placebo (P<0.001). Le comprimé combine du midazolam (3mg) et de la kétamine (50mg), se dissolvant en 3 secondes grâce à la technologie Zydis® de Catalent. Les patients recevant uniquement du midazolam nécessitaient presque deux fois plus de sédation de secours comparativement à MELT-300 (P=0.003), tandis que MELT-300 présentait un profil de sécurité favorable comparable à celui du placebo.
Melt Pharmaceuticals hat positive vorläufige Ergebnisse der Phase 3 für MELT-300 angekündigt, eine nicht-intravenöse, nicht-opioide sublinguale Tablette zur Procedural-Anästhesie während der Kataraktoperation. Die Studie, die über 530 Patienten an 13 klinischen Standorten in den USA umfasste, zeigte die statistische Überlegenheit von MELT-300 gegenüber sowohl sublingualem Midazolam (P=0.009) als auch Placebo (P<0.001). Die Tablette kombiniert Midazolam (3mg) und Ketamin (50mg), das sich in 3 Sekunden mit der Zydis®-Technologie von Catalent auflöst. Patienten, die nur Midazolam erhielten, benötigten fast doppelt so viel Rettungsanästhesie im Vergleich zu MELT-300 (P=0.003), während MELT-300 ein günstiges Sicherheitsprofil zeigte, das dem von Placebo vergleichbar war.
- Achieved statistical superiority over both midazolam and placebo in Phase 3 trial
- Demonstrated favorable safety profile comparable to placebo
- Reduced need for rescue sedation by approximately 50% compared to midazolam
- Potential market of over 5 million annual cataract surgeries in the U.S.
- Possible expansion to over 100 million annual procedures across various medical specialties
- Product still requires FDA approval
- Currently to cataract surgery applications
Insights
The Phase 3 trial results for MELT-300 represent a significant breakthrough in procedural sedation. The study demonstrated statistically superior efficacy compared to both sublingual midazolam (p=0.009) and placebo (p<0.001), with nearly 50% fewer patients requiring rescue sedation versus midazolam alone. This robust data from over 530 patients across 13 U.S. sites strongly positions MELT-300 for FDA approval.
The market opportunity is substantial, with over 5 million annual cataract surgeries expected in the U.S. alone. The potential expansion to other procedures could increase the addressable market to over 100 million procedures annually across various specialties. The non-IV, non-opioid nature of MELT-300, combined with its rapid dissolution time of 3 seconds using Catalent's Zydis® technology, offers a compelling alternative to current sedation protocols.
The Special Protocol Assessment (SPA) agreement with the FDA provides a strong regulatory foundation for MELT-300's approval pathway. The positive Phase 3 results meeting the predetermined endpoints significantly de-risks the regulatory submission process. The company's robust patent portfolio, both domestic and international, should be further strengthened by this clinical data, providing substantial intellectual property protection for future commercialization.
MELT-300 Demonstrates Statistically Superior Compared to Both Sublingual Midazolam (P=0.009) and Placebo (P<0.001) for Providing Successful Procedural Sedation
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
MELT-300 uniquely combines a fixed dose of midazolam (3mg) and ketamine (50mg) in one tablet that is administered sublingually using Catalent’s proprietary Zydis® delivery technology which dissolves in as little as 3 seconds allowing absorption of the active ingredients across the sublingual mucosa.
The MELT-300 Phase 3 clinical trial was 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 in patients undergoing cataract surgery. The study was conducted at 13 clinical sites in
In commenting on the topline results, Dr. Larry Dillaha, Chief Executive Officer of Melt, said, “We are extremely excited with this robust topline data from our pivotal Phase 3 study. These overwhelmingly positive results support our belief that MELT-300, if approved by the FDA, would be a safe and effective non-IV, non-opioid alternative to current IV-based cataract surgery sedation protocols, which generally involve the administration of opioids. With the number of cataract surgeries performed each year in the
MELT-300 co-inventor, Melt Pharmaceuticals board member, and board-certified ophthalmologist John Berdahl, M.D., commented, “A proprietary compounded combination of midazolam and ketamine, which was the inspiration for the development of the MELT-300 product candidate, has been used by hundreds of ophthalmologists, including myself – in hundreds of thousands of cataract surgeries. I am thrilled at the prospect of the FDA approving MELT-300, which I believe would greatly enhance the confidence of healthcare professionals in considering the adoption of this groundbreaking sedation method.”
George Magrath, M.D., a board-certified ophthalmologist and a MELT-300 Phase 3 study principal investigator, commented, “These Phase 3 data show the superiority of the combination of midazolam and ketamine compared with midazolam alone. If approved, I believe MELT-300 will be a safe and effective alternative to current sedation methods used for cataract surgery. As an ophthalmologist, I am excited about the prospect of using MELT-300 to enhance the overall experience for my cataract surgery patients.”
Dr. Dillaha continued, “In addition to supporting a regulatory submission, these MELT-300 Phase 3 data should further strengthen our already strong patent portfolio, both domestically and internationally. Further, with these data now confirming and complementing our robust Phase 2 efficacy and safety results, we believe we are well positioned to elevate the procedural sedation standard of care for cataract surgery and, through lifecycle management, eventually expand the potential use of MELT-300 to over 100 million annual procedures in various medical specialties, including dermatology, plastic surgery, dentistry, gastroenterology, and emergency care.
“Melt Pharmaceuticals is profoundly grateful to the Phase 3 MELT-300 study participants, whose involvement has been invaluable. This includes the ophthalmologists, optometrists, anesthesiologists, certified registered nurse anesthetists, staff, and patients at the 13 U.S. clinical sites.”
About Melt Pharmaceuticals
Melt Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing proprietary non-IV, non-opioid, sedation, and analgesia therapeutics for human medical procedures in the hospital, outpatient, and in-office settings. Melt intends to seek regulatory approval through the FDA’s 505(b)(2) regulatory pathway for its proprietary, patented small-molecule product candidates, where possible. Melt’s core intellectual property is the subject of multiple granted patents in
Forward-Looking Statements
This press release contains forward-looking statements, which are all statements other than those statements of historical facts. No representation or warranty is made as to such statements, all of which involve substantial risks and uncertainties. Actual results could vary materially.
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Investor Contact:
Larry Dillaha, M.D.
Chief Executive Officer
ldillaha@meltpharma.com
Media Contact:
Deb Holliday
Holliday Communications, Inc.
deb@hollidaycommunications.net
412-877-4519
Source: Melt Pharmaceuticals, Inc.
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