Melt Pharmaceuticals, a subsidiary of Imprimis Pharmaceuticals, announced that following the presentation of clinical data on the MKO Melt (midazolam/ketamine/ondansetron) from a 611-patient IRB approved prospective, controlled, randomized, three arm comparator study at the American Academy of Ophthalmology meeting this month, additional studies on Melt’s drug candidates will soon begin. Both new studies, along with an upcoming pre-IND meeting with FDA, which is scheduled for this coming January, will inform the clinical development programs Melt expects to begin during 2019.
Pharmacokinetics and Pharmacodynamics of the MK Melt (Sublingual Midazolam and Ketamine)
The objective of this study is to establish the pharmacokinetics and pharmacodynamics of midazolam and ketamine following administration of the patented MK Melt in up to 25 healthy volunteers under an IRB approved protocol with informed consent. These measurements will identify the time course of effects of the MK Melt in relation to the concentrations of its component drugs in the body.
The study will define a window of sedation for the MK Melt in the volunteers, which will provide vital information for physicians and anesthesiologists related to the duration and quality of sedation. Included in the study will be monitoring of vital signs, blood levels, evaluation of the level of volunteers’ sedation over time, and satisfaction questionnaires completed by volunteers and study personnel both during and at the conclusion of the study, which will provide vigorous assessments of the sedation achieved with the MK Melt. By establishing the time course of its anesthesia effects, this study should provide data that will allow anesthesiologists to optimize the timing of administration and dosing of the MK Melt for different sedation procedures.
This study is expected to be completed during the fourth quarter of 2018.
Pharmacodynamics of the MKO Melt (Sublingual Midazolam, Ketamine, and Ondansetron) During Oral Surgery & Dental Procedures
This multicenter clinical study is designed to evaluate the safety and efficacy of the MKO Melt for conscious sedation during dental surgery. There are eight participating sites with investigators that include leading oral maxillofacial surgeons, internationally acclaimed pioneers in dental procedures, and faculty members in dental medicine education from leading teaching institutions. This study anticipates at least 100 participants to be recruited and that the inclusion criteria will provide for a wide range of population groups at each participating center.
In this study, the MKO Melt for conscious/moderate sedation will be assessed across a breadth of medical dentistry indications including oral and maxillofacial surgery, dental specialties such as periodontics and endodontics, as well as general dentistry. The participating investigators plan to administer the MKO Melt to patients under an IRB approved protocol with informed consent during the patients’ scheduled dental procedures.
The objective of this study is to evaluate the MKO Melt for management of pain/discomfort and anxiety during dental procedures and surgery. We anticipate that the multiple measures of sedation and satisfaction in this protocol provide a robust study design and will allow for definitive conclusions to be drawn.
This study is expected to be completed in the second or third quarter of 2019.