A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)

The goal of this clinical trial is to learn if MELT-300 works on procedural sedation in adult participants undergoing cataract extraction with lens replacement (CELR). It will also learn about the safety of MELT-300. Researchers will compare MELT-300 to a placebo (a look-alike substance that contains no drug) to see if MELT-300 works on procedural sedation in adult participants undergoing CELR. Researchers will also include a comparator SL midazolam to confirm the benefit of inclusion of ketamine in the combined drug product.
The main questions it aims to answer are:
1. Does MELT-300 is effective in comparison to placebo on procedural sedation for cataract surgery?
2. To determine the effectiveness of MELT-300 compared with midazolam on procedural sedation (to determine the contribution of ketamine component and inform the risk of ketamine in MELT-300)
3. To determine the time to achieve preoperative target sedation level with MELT-300
4. What medical problems do participants have when taking MELT-300 vs placebo
Eligible participants will admitted to the study unit on Day 1. Participants will be randomized prior to surgery 4:1:1 to
1. MELT-300 (i.e. 1 MELT-300 sublingual tablet which contains 3 mg midazolam and 50 mg of ketamine)
2. Midazolam (i.e. 1 matching midazolam sublingual tablet which contains 3 mg midazolam)
3. Placebo (i.e. 1 matching placebo sublingual tablet)
Participants will receive study medication 30 (± 5) minutes, without food or water, before planned surgery start (defined as instillation of topical ocular anesthetic gel [i.e.. 3 drops of chloroprocaine hydrochloride ophthalmic gel)].
The effectiveness of MELT-300 will be performed after study medication is administered before surgery, in the course of surgery, and postoperative on Day 1 (end of surgery defined as just prior to drape removal). The safety of MELT-300 will be performed at baseline, in the course of surgery, postoperatively on Day 1, and on Day 3 ± 1 day post dose of study medication.

开始日期2024-05-01

申办/合作机构

Melt Pharmaceuticals, Inc.初创企业

[+4]

CTRI/2024/01/061815 / Completed临床2/3期IIT

Comparative Evaluation of IntranasalDexmedetomidine-Ketamine, Ketamine-Midazolam and Nitrous oxide-Oxygen inhalation forconscious sedation of 5-10 year old Anxious Children Undergoing Dental Treatment:A Randomised Clinical Trial - NIL

开始日期2024-01-29

申办/合作机构-

NCT06122948 / Recruiting临床3期IIT

Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication in Children Undergoing Tonsillectomy and Adenoidectomy on the Occurrence of Postoperative Respiratory Adverse Events: a Double-blind, Randomized Controlled Trial

The aim of this study is to investigate the effect of addition of intranasal ketamine to midazolam compared to midazolam alone as a premedication on the occurrence of PRAEs

开始日期2023-09-10

申办/合作机构

Qasr El Eyni Hospital

100 项与咪达唑仑/盐酸氯胺酮相关的临床结果

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100 项与咪达唑仑/盐酸氯胺酮相关的转化医学

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100 项与咪达唑仑/盐酸氯胺酮相关的专利（医药）

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项与咪达唑仑/盐酸氯胺酮相关的文献（医药）

2019-06-01·Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology1区 · 医学

Impact of midazolam vs. saline on effect size estimates in controlled trials of ketamine as a rapid-acting antidepressant

1区 · 医学

Article

作者: Sos, Peter ; Ballard, Elizabeth D ; Farmer, Cristan ; Wilkinson, Samuel T ; Gueorguieva, Ralitza ; Zarate, Carlos A ; Wang, Gang ; Mathew, Sanjay J ; Murrough, James W ; Grunebaum, Michael F

The goal of this study was to infer the effectiveness of midazolam as a comparator in preserving the blind in ketamine studies for mood disorders through patient-level analyses of efficacy trial outcomes. In this integrative data analysis (k = 9, N = 367 patients with mood disorders), clinical outcomes were compared across four groups: ketamine (midazolam-controlled), ketamine (saline-controlled), midazolam, and saline. Ketamine doses ranged from 0.5 to 0.54 mg/kg and midazolam doses ranged from 0.02 to 0.045 mg/kg. The baseline-to-Day 1 effect size was d = 0.7 (95% CI: 0.4-0.9) for ketamine (midazolam) versus midazolam and d = 1.8 (95% CI: 1.4-2.2) for ketamine (saline) versus saline. The effect of ketamine relative to control was larger in saline-controlled studies than in midazolam-controlled studies (t(276) = 2.32, p = 0.02). This was driven by a comparatively larger effect under midazolam than saline (t(111) = 5.40, p < 0.0001), whereas there was no difference between ketamine (midazolam) versus ketamine (saline) (t(177) = 0.65, p = 0.51). Model-estimated rates of response (with 95% CI) yielded similar results: ketamine (midazolam), 45% (34-56%); ketamine (saline), 46% (34-58%); midazolam, 18% (6-30%); saline, 1% (0-11%). The response rate for ketamine was higher than the control condition for both saline (t(353) = 7.41, p < 0.0001) and midazolam (t(353) = 4.59, p < 0.0001). Studies that used midazolam as a comparator yielded smaller effects of ketamine than those which used saline, which was accounted for by greater improvement following midazolam compared to saline.

项与咪达唑仑/盐酸氯胺酮相关的新闻（医药）

2024-06-06

·BioSpace

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

Topline Readout Expected in Q4 2024 NASHVILLE, Tenn.--(BUSINESS WIRE)-- Melt Pharmaceuticals, Inc. (“Melt”), a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced that the first patient has been dosed in its Phase 3 program evaluating the safety and efficacy of its lead product candidate, MELT-300, a non‑IV, non-opioid tablet that combines fixed doses of midazolam (3mg) and ketamine (50mg). MELT-300 is administered sublingually using Catalent Inc.’s proprietary fast‑dissolving Zydis® delivery technology to rapidly dissolve the tablet for absorption across the sublingual mucosa. 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 for procedural sedation in 528 patients undergoing cataract surgery at 14 participating clinical sites. The topline readout is expected in the fourth quarter of 2024. Melt previously announced the results from its MELT-300 Phase 2 clinical trial in patients undergoing cataract surgery. The Phase 2 clinical trial compared MELT-300 against (i) sublingual placebo alone, (ii) sublingual midazolam, and (iii) sublingual ketamine in over 300 patients. MELT-300 was statistically superior for procedural sedation compared to all individual comparator arms: (i) sublingual placebo (P <0.0001), (ii) sublingual midazolam (P=0.0129) and (iii) sublingual ketamine (P=0.0096). In commenting on the announcement, Dr. Larry Dillaha, Chief Executive Officer of Melt, said, “We are very excited to announce the first dosing in our pivotal Phase 3 program. Over the past 20 years, a lack of innovation in outpatient procedural sedation has created a significant unmet need, with IV‑administered medications being a procedural mainstay and contributing to an increase in opioid usage. We believe that MELT-300 could revolutionize procedural sedation while enhancing the patient’s experience in all sites of care by offering greater comfort without a needle stick and by reducing exposure to opioids.” Dr. Dillaha added, “While we are initially targeting sedation during cataract surgery for MELT-300, estimated to be over 5 million annual procedures in the U.S. in the coming years, we believe with further development and label expansion, MELT-300 could be utilized in over 100 million annual procedures in areas such as dermatology, plastics, dental, gastrointestinal, and emergency rooms.” About Melt Pharmaceuticals Melt Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing proprietary non-opioid, non-IV, 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 North America, Europe, Asia, and the Middle East. Melt Pharmaceuticals, Inc. is a former subsidiary of Harrow, Inc. (Nasdaq: HROW) and was carved out as a separately managed business in 2019. To learn more about Melt, please visit their website, .

临床3期临床2期临床结果

2024-04-02

·BioSpace

Melt Pharmaceuticals Closes $24 Million Series B Preferred Stock Financing

MELT-300 Pivotal Phase 3 Program Topline Readout Expected in Q4 2024 NASHVILLE, Tenn.--(BUSINESS WIRE)-- Melt Pharmaceuticals, Inc. (“Melt”), a clinical‑stage pharmaceutical company developing novel approaches for procedural sedation, today announced the completion of its Series B Preferred Stock financing of approximately $24 million from new and existing investors at a pre‑money valuation that increased nearly 150% from the pre-money valuation for Melt’s Series A Preferred Stock financing in 2019. The capital raised will primarily support the further development of MELT-300, including the MELT-300 Phase 3 program. MELT-300, a non-IV, non‑opioid tablet that combines fixed doses of midazolam (3mg) and ketamine (50mg), is administered sublingually using Catalent Inc.’s proprietary fast‑dissolving Zydis® delivery technology to rapidly dissolve the tablet for absorption across the very thin sublingual mucosa. The MELT-300 Phase 3 program commenced in the first quarter of 2024, with first patient dosing expected in the second quarter of 2024 and a topline readout expected in the fourth quarter of 2024. “Melt is seeking to drive a paradigm shift in procedural sedation, fulfilling an unmet need to provide a needle- and opioid-free alternative for procedural sedation, especially in cataract surgeries, which are estimated at over 4.5 million procedures in the U.S. As we continue to develop our patented technologies, we believe we can also impact the more than 100 million short-duration medical procedures nationwide,” said Dr. Larry Dillaha, Chief Executive Officer of Melt. “If approved, we expect MELT-300 will enhance the patient’s experience in all sites of care by offering greater comfort without a needle stick and by reducing exposure to opioids. “With this round of financing, we’ve obtained the funding to further the development of MELT-300, including conducting our recently commenced Phase 3 program. We are grateful for the ongoing support from our current investors and are pleased to welcome new investors to our company. Their shared belief in the vision of MELT-300 and their confidence in its potential to revolutionize short-duration procedural sedation is incredibly valuable to us.” Newbridge Securities Corporation acted as the exclusive placement agent for the Series B Preferred Stock Offering. About Melt Pharmaceuticals Melt Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing proprietary non-opioid, non-IV, 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 North America, Europe, Asia, and the Middle East. Melt Pharmaceuticals, Inc. is a former subsidiary of Harrow, Inc. (Nasdaq: HROW) and was carved out as a separately managed business in 2019. To learn more about Melt, please visit their website, .

临床3期

2024-01-03

·Business Wire

Melt Pharmaceuticals Provides Corporate Update

NASHVILLE, Tenn.--( BUSINESS WIRE )--Melt Pharmaceuticals, Inc. (“Melt”), a clinical‑stage pharmaceutical company developing novel approaches for procedural sedation, today provided a corporate update. The Company previously announced that MELT-300 achieved the primary sedation endpoint in its Phase 2 Pivotal Efficacy and Safety Study in subjects undergoing cataract surgery. MELT‑300, a non-IV, non-opioid tablet that combines fixed doses of midazolam (3mg) and ketamine (50mg), is administered sublingually using Catalent Inc.’s proprietary fast‑dissolving Zydis® delivery technology to rapidly dissolve the tablet for absorption across the very thin sublingual mucosa. Melt Pharmaceuticals recently received a written response from the U.S. Food and Drug Administration (FDA) regarding its planned MELT-300 Phase 3 program. Based on the FDA’s response, Melt Pharmaceuticals expects to begin Phase 3 program activities, which will consist of a single pivotal study comparing MELT-300 to sublingual midazolam and placebo in subjects undergoing cataract surgery, in the first quarter of 2024. Additionally, Melt has now reached an agreement with and paid in full all the outstanding principal and accrued and unpaid interest under its loan facility with Harrow , Inc. (Nasdaq: HROW), Melt’s largest shareholder, through the issuance of shares of Melt’s Series B and Series B-1 Preferred Stock. Following this transaction, in addition to certain royalty rights, Harrow’s equity ownership percentage of Melt is approximately 47%. “ We are very pleased to have received a response from the FDA that supports the investment we are making in our proposed MELT‑300 Phase 3 program,” said Dr. Dillaha. “ This was the last step needed to finalize our program design, paving the way for the commencement of Phase 3 program activities in early 2024. Following the debt settlement with Harrow and our successful efforts to date to secure sufficient funding to commence the Phase 3 program, we can now focus on the advancement of our non-IV, non‑opioid MELT-300 product candidate, which we believe has the potential to revolutionize short‑duration procedural sedation for more than 100 million U.S. medical procedures, enhancing the surgical patient experience by providing greater comfort and reducing reliance on opioids.” About Melt Pharmaceuticals Melt Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing proprietary non-opioid, non-IV, 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 North America, Europe, Asia, and the Middle East. Melt Pharmaceuticals, Inc. is a former subsidiary of Harrow, Inc. (Nasdaq: HROW) and was carved out as a separately managed business in 2019. To learn more about Melt, please visit their website, www.meltpharma.com .

临床3期临床2期临床结果

100 项与咪达唑仑/盐酸氯胺酮相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
白内障	临床3期	美国	Melt Pharmaceuticals, Inc.初创企业	2024-05-01
药物不良反应	临床3期	埃及	Qasr El Eyni Hospital	2023-09-10
镇静	临床2期	美国	Melt Pharmaceuticals, Inc.初创企业	2021-07-20

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Biospace 人工标引	临床2期	白内障	-	MELT‑300	艱製糧餘觸夢網廠範遞(製夢醖醖艱鹽願鹹鏇繭) = MELT-300 achieved the primary sedation endpoint in its Phase 2 Pivotal Efficacy and Safety Study in subjects undergoing cataract surgery. 願製憲餘鏇糧糧夢壓獵 (顧襯獵網窪遞簾醖網鬱 )	积极	2024-01-03
NCT03054103 (CTgov)	临床4期	白内障	105	Midazolam + Normal saline (Midazolam Alone)	築夢築蓋蓋餘壓壓廠夢(願製獵膚膚窪餘觸鬱膚) = 憲窪選觸選襯遞獵壓願製製網選築繭鏇膚憲構 (範遞顧鹹壓鏇廠窪選鏇, 構廠蓋觸鹹夢鬱獵醖糧 ~ 鏇鑰築簾夢齋構選觸淵) 更多	-	2018-01-19
NCT03054103 (CTgov)	临床4期	白内障	105	Midazolam + Ketamine 10 MG/ML: 0.5 ML (Midazolam + Ketamine 5 mg)	築夢築蓋蓋餘壓壓廠夢(願製獵膚膚窪餘觸鬱膚) = 鬱蓋構廠鑰醖襯醖築淵製製網選築繭鏇膚憲構 (範遞顧鹹壓鏇廠窪選鏇, 憲鑰淵繭製構築齋觸膚 ~ 廠鹽艱範範願築構積鹽) 更多	-	2018-01-19