MDL-001 (Exonal®)(Buccal Naloxone for Opioid Overdose): Exonal® has been demonstrated in pilot clinical trials to deliver effective levels of naloxone as rapidly as the reference listed intramuscular injection.
Drug overdose deaths are now the leading cause of injury death in the United States. They surpass deaths from motor vehicle crashes and result mostly from prescription drug overdose. Mucodel believes that Co-Gel buccal naloxone (Exonal®) will have significant advantages over existing treatment options including the nasal spray.
Exonal® advantages include:
• more reliable efficacy than naloxone nasal spray
• improved ease of administration - dosing placement can be taught and seen
• lower manufacturing than other competing products that require sterile manufacture
• equally rapid onset to intramuscular (IM) injection despite the non-invasive oromucosal route
• equal extent of absorption compared to the intranasal spray
MDL-002 (Buccal NSAID) (Indication Undisclosed): MDL-002 has been demonstrated in pilot clinical trials to deliver peak concentration on the undisclosed NSAID within thirty minutes; substantially faster than the reference listed intramuscular therapy.
MDL-003 (Buccal Diazepam) (Breakthrough Seizure Control): MDL-003 has been demonstrated in pilot clinical trials to deliver peak concentration of diazepam in less than one hour, substantially faster than the reference listed diazepam rectal gel (not accounting for quicker speed to administer the buccal formulation as compared with the RLD).
MDL-004 (Buccal Undisclosed) (Indication Undisclosed): MDL-004 is a buccal version of a drug that is currently available solely in parenteral form.