Greensboro, NC, Dec. 11, 2017 (GLOBE NEWSWIRE) --

Mucodel Pharma LLC (“Mucodel”) today announced the successful completion of a pilot clinical study involving intranasal naloxone, a Mucodel product under development for the reversal of opioid overdose.

The tested intranasal formulation employs Mucodel’s Co-Gel platform for the mucosal delivery of pharmaceutically active agents.  The Co-Gel platform is particularly well suited for rescue therapeutics requiring rapid absorption.

The study met its objectives and demonstrated that the Mucodel formulation rapidly delivered the targeted naloxone dose, with a substantial speed advantage over published results for both the approved, reference naloxone nasal spray, as well as intramuscular injection.   The Mucodel intranasal formulation achieved Tmax at the five minute time point, with a substantial improvement in peak plasma concentration compared with the reference naloxone nasal spray.

Founder and CEO, Dr. Madhu Hariharan, stated: “We are extremely pleased with the pilot clinical results for our Co-Gel intranasal naloxone.  It is clear from the ongoing opioid crisis that faster ways of delivering naloxone are desperately needed.  Speed to efficacious blood levels is crucial for patients in respiratory distress.   Moreover, higher peak plasma naloxone concentrations are needed to combat overdose associated with particularly powerful opioids.”

Joseph Fuisz, head of business development for Mucodel, stated: “We are proud to share these positive results.  We have demonstrated the functionality of the Co-Gel technology platform for both oral and nasal mucosal surfaces.  We look forward to announcing the results of our other Co-Gel clinical programs to address unmet medical needs.”
Naloxone is a Food and Drug Administration (FDA) approved agent that treats the effects of opioid overdose caused by the use or misuse of prescription and illicit opioids. US deaths from opioid overdose currently exceed 8 per 100,000, are increasing further and are on track to eclipse automobile fatalities (10.25 per 100,000). The majority of deaths occur at home.

About Mucodel Pharma:
The mission of Mucodel is to develop improved rescue therapies that are mucosally administered.  Mucodel’s Co-Gel platform enables the improved mucosal delivery of drugs, and in some cases allows for the mucosal delivery of drugs that are otherwise not able to be delivered mucosally.  We develop more convenient products that offer well defined therapeutic benefits for patients.
Mucodel is a private company based in Greensboro, North Carolina.

Madhu Hariharan:

Joseph Fuisz: