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

Rhea-AI Summary

Melt Pharmaceuticals has dosed the first patient in its Phase 3 clinical trial for MELT-300, a non-IV, non-opioid sedation tablet, targeting procedural sedation during cataract surgery. MELT-300 combines midazolam and ketamine in a sublingual, fast-dissolving format. The trial is a randomized, double-blind study involving 528 patients across 14 clinical sites, comparing MELT-300 to sublingual midazolam and a placebo. Previous Phase 2 trials showed MELT-300's superior efficacy. Topline results are expected in Q4 2024. CEO Dr. Larry Dillaha highlighted the innovation in sedation and potential expansion to over 100 million annual procedures in various medical fields.

Positive

• First patient dosed in Phase 3 trial for MELT-300, showing progress in clinical development.
• MELT-300 is a non-IV, non-opioid option, potentially reducing opioid use.
• Phase 3 trial involves 528 patients across 14 sites, indicating robust study design.
• Previous Phase 2 trial showed MELT-300's statistical superiority in sedation.
• Potential market expansion to over 100 million annual procedures in various medical fields.
• Topline results expected in Q4 2024, providing a clear timeline for data availability.

Negative

• Results from the Phase 3 trial won't be available until Q4 2024, leading to a long wait for investors.
• Uncertainty in market adoption due to competition with established IV-administered sedation methods.
• Clinical trial success doesn't guarantee regulatory approval or market success.

Insights

Medical Research Analyst

MELT-300 represents a significant advancement in procedural sedation, particularly for cataract surgeries. This is especially noteworthy given the ongoing challenges with opioid dependence and the need for non-invasive sedation methods. By leveraging sublingual delivery, MELT-300 could potentially offer a faster onset of sedation compared to traditional IV methods, while also eliminating the discomfort associated with needles. Moreover, the inclusion of midazolam and ketamine—a combination known for effective sedation—suggests a robust rationale behind this formulation.

Considering the $5 million annual U.S. cataract procedures, initial adoption in this market alone presents substantial opportunities. Further label expansion to additional procedures could exponentially increase its market potential, tapping into a larger unmet need in procedural sedation across various medical fields. Investors should monitor the Phase 3 trial results closely, as positive outcomes could drive significant market adoption and partnerships.

Market Research Analyst

The launch of MELT-300’s Phase 3 program marks a pivotal moment for Melt Pharmaceuticals. Their proprietary approach using Catalent Inc.'s Zydis® technology indicates a competitive edge in the fast-dissolving drug delivery market. Should the trial results align with those from Phase 2, MELT-300 could disrupt traditional sedation methods, particularly in outpatient settings.

Given the substantial market size, with cataract surgeries alone accounting for $5 million procedures annually in the U.S., the financial upside is considerable. The broader potential applications in dermatology, plastics, dental and emergency procedures could further amplify its market impact. Investors should weigh the associated regulatory and market risks, but the high unmet need in non-opioid sedation solutions positions MELT-300 as a potentially transformative product.

Financial Analyst

Melt Pharmaceuticals stands to benefit significantly from the positive progression of its Phase 3 trial for MELT-300. The financial implications are profound if the product reaches commercialization. The company's approach to non-opioid sedation aligns well with the current healthcare landscape's shift towards reducing opioid dependency. Additionally, the fast-dissolving sublingual delivery method may offer a cost-effective and patient-friendly alternative to traditional IV sedation, potentially leading to higher adoption rates and market penetration.

Investors should prepare for potential short-term volatility linked to trial results and regulatory milestones. However, the long-term outlook appears promising, particularly if MELT-300's efficacy and safety profile are validated. A diverse application range across multiple medical fields could further drive revenue growth and investor confidence.

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, www.meltpharma.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240606803052/en/

Investor Contact:

Larry Dillaha, M.D.

Chief Executive Officer

ldillaha@meltpharma.com

412-877-4519

Media Contact:

Deb Holliday

Holliday Communications, Inc.

deb@hollidaycommunications.net

Source: Melt Pharmaceuticals, Inc.

FAQ

What is MELT-300?

MELT-300 is a non-IV, non-opioid sedation tablet combining midazolam and ketamine, used for procedural sedation.

What phase is the MELT-300 clinical trial currently in?

The MELT-300 clinical trial is currently in Phase 3.

When are the topline results for the MELT-300 Phase 3 trial expected?

Topline results for the MELT-300 Phase 3 trial are expected in Q4 2024.

How many patients are involved in the MELT-300 Phase 3 trial?

The MELT-300 Phase 3 trial involves 528 patients.

What method of administration does MELT-300 use?

MELT-300 is administered sublingually using Catalent's Zydis fast-dissolving technology.

What were the results of the MELT-300 Phase 2 trial?

The Phase 2 trial showed MELT-300's statistical superiority in sedation compared to sublingual placebo, midazolam, and ketamine.

What is the potential market for MELT-300?

MELT-300 could potentially be used in over 100 million annual procedures in fields like dermatology, plastics, dental, gastrointestinal, and emergency rooms.