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Products

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.

Management

Madhu Hariharan Company name
Madhu Hariharan founded Mucodel LLC in 2014 with the vision of developing technologies for enhancing drug delivery via mucosal routes of administration.

He has worked in the area of complex drug delivery systems for the majority of his 18+ years in the pharmaceutical industry.

He has diverse work experience in product development, regulatory filing and commercial launch of Rx, generic and OTC pharmaceuticals and nutraceuticals.

He has served in a variety of technical leadership positions at Specialty Pharma/Drug Delivery companies as well as Large Pharma and Generics Companies.

His most recent employed affiliation was at Banner Life Sciences where he served as head of North American R&D and Regulatory Affairs.

In 2012 he founded Solvekta Associates, a CMC consulting firm of 6 professionals dedicated to assisting small and mid-size pharmaceutical companies in pre-formulation, formulation, process development, regulatory filing and strategy for pharmaceutical thin films, implants and other complex dosage forms.

He is the author of several scientific publications and is inventor on a number of patents in the area of drug delivery.

Madhu Hariharan has Bachelor's degree in Pharmacy and a Ph.D in Pharmaceutics.
Joseph Fuisz Company name
Joseph Fuisz is an attorney and has worked in the pharmaceutical industry for sixteen years.

He is a named inventor on over thirty issued US patents, principally related to drug delivery systems.

Mr. Fuisz helped to co-found MonSol Rx, LLC, a thin film drug delivery company, and served as its Senior Vice President for Business Development.

At MonoSol Rx, Mr. Fuisz led multiple strategic transactions with leading pharma companies for ethical and OTC drugs, including the development and supply of Suboxone® thin film.

Mr. Fuisz co-founded Fuisz Tobacco based on a novel oral tobacco delivery system employing an extruded sheet format, and successfully sold Fuisz Tobacco to a leading global tobacco company.

Mr. Fuisz served as president of vaginal drug delivery company Femina Pharma, whose assets were acquired by Teva.

At Fuisz Pharma, Mr. Fuisz has been active in the design of new, patented tablet designs for improved esophageal transit.

Joseph Fuisz has a Bachelor’s degree in Economics from Yale University and a JD from the Columbia University School of Law.

He is a member of bar in the State of New York and the District of Columbia.

Our Pipeline


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