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Press Release

Mucodel Pharma Announces Successful Completion of Buccal Naloxone Pilot Clinical Study

Posted on: 21 Sep 16

GREENSBORO, N.C., Sept. 21, 2016 (GLOBE NEWSWIRE) -- Mucodel Pharma LLC (“Mucodel”) today announced the successful completion of a pilot clinical study involving buccal naloxone (Exonal™), a Mucodel product under development for the reversal of opioid overdose.

Exonal™ employs Mucodel’s Co-Gel platform for oromucosal delivery of pharmaceutically active agents and is particularly suitable for rescue therapeutics requiring rapid absorption.

The pilot pharmacokinetic study compared Exonal™ buccal naloxone with an approved intramuscular injectable naloxone.

The study met its objectives and demonstrated that Exonal™ rapidly delivered the targeted naloxone dose, with comparable Cmax and Tmax to the approved intramuscular injectable reference product.

Founder and CEO, Dr. Madhu Hariharan, stated: “We are pleased with the pilot clinical results for Exonal™ buccal naloxone. The remarkably rapid transit of naloxone through the buccal mucosal barrier for this critical rescue therapy speaks very well for our Co-Gel platform technology.”

Joseph Fuisz, head of business development, stated: “Exonal™ buccal naloxone offers a series of substantial value added features as compared with existing treatment options including improved reliability and ease of administration. Dosing placement can be readily taught and seen.”

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.

Currently, there is no approved naloxone rescue product with an oromucusol route of administration. FDA approved formulations of rescue naloxone include injectable products and a nasal spray.

About Mucodel Pharma:

The mission of Mucodel is to develop improved rescue therapies that are oromucosally administered.  Mucodel’s proprietary Co-Gel technology allows for oromucosal administration of existing drugs that would not otherwise be amenable to oromucosal delivery. Mucodel’s Co-Gel platform enables more convenient products and offers tangible therapeutic benefits to patients.

Mucodel is a private company based in Greensboro, North Carolina.  


Last updated on: 22/09/2016

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