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Also known as MELT-300 sublingual tablet
MELT-300 · 2 trials · 1 indication
Successful procedural sedation is defined as achieving target sedation level (Ramsay Sedation Scale \[RSS\] level 2 or 3) by the start of surgery without need for rescue sedation medication, no requirement for intraoperative sedation medication, and able to complete the surgery (i.e. procedural sedation responder). The Ramsay Sedation Scale (RSS) was the first scale to be defined for the sedated participants and was designed as a test of arousability. The Ramsay Scale provides three levels of 'awake' states (score 1-3) and three levels of 'asleep' states (score 4-6). A score of 2 (participant is cooperative, orientated, and tranquil) best fits an optimum sedation level based on the criteria of calm, comfortable, communicative, and cooperative participants.
The Ramsay Sedation Scale (RSS) was the first scale to be defined for the sedated participants and was designed as a test of arousability. The Ramsay Scale provides three levels of 'awake' states (score 1-3) and three levels of 'asleep' states (score 4-6). A score of 2 (participant is cooperative, orientated, and tranquil) best fits an optimum sedation level based on the criteria of calm, comfortable, communicative, and cooperative participants. Ramsay Sedation Scale 1. =Participant is anxious and agitated or restless, or both 2. =Participant is cooperative, oriented, and tranquil 3. =Participant responds to commands only 4. =Participant exhibits brisk response to a light glabellar tap or loud auditory stimulus 5. =Participant exhibits a sluggish response to a light glabellar tap or loud auditory stimulus 6. =Participants exhibits no response RSS score will be assessed pre-operatively, intra-operatively, and post-operatively on Day 1
The Numeric Pain Rating Scale (NPRS) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
| Arm | Type | Description |
|---|---|---|
| MELT-300 sublingual tablet | EXPERIMENTAL | Participants will receive a single dose of MELT-300 sublingual, tablet containing 3 mg of midazolam and 50 mg of ketamine. |
| Midalozam sublingual tablet | ACTIVE_COMPARATOR | Participants will receive a single dose of midazolam 3 mg sublingual tablet. |
| Placebo sublingual tablet | PLACEBO_COMPARATOR | Participants will receive a single dose of a matching placebo sublingual tablet. |
| MELT-300 | ACTIVE_COMPARATOR | Participants will receive a single dose of MELT-300 sublingual, rapidly dissolving tablet containing 3 mg of midazolam and 50 mg of ketamine. |
| Midazolam alone | ACTIVE_COMPARATOR | Participants will receive a single dose of midazolam 3 mg sublingual tablet. |
| Ketamine alone | ACTIVE_COMPARATOR | Participants will receive a single dose of ketamine 50 mg sublingual tablet. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of a matching placebo sublingual tablet. |
| Name | Type | Description |
|---|---|---|
| MELT-300 sublingual tablet | DRUG | Each dose of MELT-300 will be provided as a single sublingual tablet, containing 3 mg midazolam and 50 mg ketamine. Participants will receive 1 sublingual tablet of study medication 30 (± 5) minutes prior to planned surgery start, without food or water. |
| Midalozam sublingual tablet | DRUG | Each dose of midazolam will be provided as a single sublingual tablet, containing 3 mg midazolam. Participants will receive 1 sublingual tablet of study medication 30 (± 5) minutes prior to planned surgery start, without food or water. |
| Placebo sublingual tablet | DRUG | Each dose of placebo will be provided as a matching sublingual tablet, containing placebo. Participants will receive 1 sublingual tablet of study medication 30 (± 5) minutes prior to planned surgery start, without food or water. |
| MELT-300 | DRUG | Sublingual tablet |
| Midazolam alone | DRUG | Sublingual tablet |
| Ketamine alone | DRUG | Sublingual tablet |
| Placebo | DRUG | Sublingual tablet |
Inclusion Criteria: Participants must meet all of the following in order to be enrolled into the study: 1. Males and females ≥ 18 years of age 2. Are to undergo unilateral primary CELR under topical anesthesia, with a phacoemulsification device and insertion of an intraocular lens (no restrictions...
MELT-300 is an investigational sublingual tablet being developed for sedation and intraocular ocular analgesia in patients undergoing cataract extraction with lens replacement (CELR). It is a small molecule being studied in the ophthalmology therapeutic area for cataract procedures.
MELT-300 is a combination sublingual tablet containing midazolam and ketamine. Midazolam is a benzodiazepine that acts on GABA-A receptors to produce sedation, while ketamine is an NMDA receptor antagonist that provides analgesia and dissociative sedation.
MELT-300 is being developed by Harrow, Inc., a pharmaceutical company traded on the NASDAQ under the ticker symbol HROW. The company is advancing the drug through clinical development for use in cataract surgery procedures.
MELT-300 is currently in Phase 3 clinical development. A Phase 2 study has been completed, and a Phase 3 trial is actively recruiting participants to evaluate the drug's efficacy and safety for procedural sedation in cataract extraction with lens replacement.
MELT-300 has two clinical trials. NCT05133518 is a completed Phase 2 study with 338 participants, and NCT06383273 is an actively recruiting Phase 3 study with a target enrollment of 528 participants. Both trials are randomized, double-blind, placebo-controlled studies conducted in the United States.
Yes, MELT-300 is also known as MELT-300 sublingual tablet. The drug is administered as a sublingual tablet formulation, which is designed to dissolve under the tongue for rapid absorption during cataract surgery procedures.