Washington Post Publisher Will Lewis Steps Down After Layoffs 
SpaceX Prioritizes Moon Mission Before Mars as Starship Development Accelerates 
Prudential Financial Reports Higher Q4 Profit on Strong Underwriting and Investment Gains 
TSMC Eyes 3nm Chip Production in Japan with $17 Billion Kumamoto Investment 
American Airlines CEO to Meet Pilots Union Amid Storm Response and Financial Concerns 
Uber Ordered to Pay $8.5 Million in Bellwether Sexual Assault Lawsuit 
Baidu Approves $5 Billion Share Buyback and Plans First-Ever Dividend in 2026 
Instagram Outage Disrupts Thousands of U.S. Users 
SoftBank Shares Slide After Arm Earnings Miss Fuels Tech Stock Sell-Off 
Sony Q3 Profit Jumps on Gaming and Image Sensors, Full-Year Outlook Raised 
CK Hutchison Launches Arbitration After Panama Court Revokes Canal Port Licences 
Trump Backs Nexstar–Tegna Merger Amid Shifting U.S. Media Landscape 
Alphabet’s Massive AI Spending Surge Signals Confidence in Google’s Growth Engine 
OpenAI Expands Enterprise AI Strategy With Major Hiring Push Ahead of New Business Offering 
Ford and Geely Explore Strategic Manufacturing Partnership in Europe 
FDA Targets Hims & Hers Over $49 Weight-Loss Pill, Raising Legal and Safety Concerns 
Amazon Stock Rebounds After Earnings as $200B Capex Plan Sparks AI Spending Debate 
GREENSBORO, N.C., Sept. 21, 2016 -- 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. www.mucodel.com
Media Contact: Madhu Hariharan [email protected] Business Development Contact: Joseph Fuisz [email protected]
