Mucodel 8646 W. Market St. Suite 111 Greensboro, NC 27409 1.336.355.8085 email@example.com
©2020 Mucodel. All rights reserved.
Who We Are
Mucodel Pharma enables drug delivery of rescue therapeutics across mucosal tissues using pH-optimized, transient supersaturation. Mucodel’s Co-Gel technology represents inspired leveraging of ‘highly unstable formulations’ of drug molecules to greatly improve their flux through mucosal barriers.
Our Mission Statement
Opioid overdose and misuse is a major public health problem in the United States and other countries, with devastating costs.
Our mission is to develop improved, mucosally administered therapies to mitigate the dangers of opioid use. Mucodel’s proprietary Co-Gel technology allows for the mucosal administration of existing drugs not otherwise amenable to mucosal delivery. Our pipeline candidates include Nasobain™ nalbuphine nasal gel for opioid pain relief, Exonal™ naloxone buccal gel for opioid overdose reversal and Exolac™ ketorolac nasal gel as an NSAID analgesic.
Chief Executive Officer
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 an 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.
Chief Commercial Officer and General Counsel
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 the bar in the State of New York and the District of Columbia.
Chief Technology Officer
Garry Myers is a chemist and pharmaceutical scientist and has worked in the drug delivery field for over 25 years.
He is a named inventor on over 250 international patents and patent applications with 90% related to drug delivery systems. Garry Myers helped co-found MonSol Rx, LLC, a thin film drug delivery company and served as its Senior Director for Formulation Development. At MonoSol Rx, Mr. Myers led multiple product development projects with leading pharma companies for ethical and OTC drugs, including the development and supply of Suboxone® thin film. Mr. Myers co-founded Kosmos Pharma and help develop the IP and technology for thin film drug delivery. Kosmos was later acquired by Monosol. Mr. Myers was the VP of R&D for Fuisz Technology an early stage pharmaceutical drug delivery start-up and was responsible for IP and product development. Fuisz Technologies later went public via IPO. Garry Myers was a Senior Chemist at Eastman and started Eastman Chemicals’ first laboratory for consumer product development. Garry Myers holds an ACS Bachelor’s degree in Chemistry from East Tn State University.
The Board of Directors
Ph.D. - Chairman
What We Do
Inspired drug delivery concept for rapid onset
Enabling non-invasive routes of administration for parenteral therapies
Mucodel’s products are based on its core technology platform, Co-Gel. Mucodel Pharma specializes in mucosal drug delivery using pH-optimized gels. Mucodel’s Co-Gel technology represents inspired leveraging of highly unstable formulations of drug molecules to greatly improve their flux through mucosal barriers.
Mucodel’s pipeline candidates utilize proprietary Co-Gel technology.
Go-Gel technology involves the extemporaneous mixing of two distinct liquids/gels within a device to produce a mucoadhesive gel which is then applied to the site of mucosal administration (e.g. buccal or intranasal). This enables Co-Gel to deliver a combined gel at optimal pH for absorption wherein the drug is in a state of supersaturation long enough to affect the intended absorption across the mucosal surface.
Urgent Unmet Needs
Drug overdose deaths are now the leading cause of injury death in the United States. Mucodel’s contribution to addressing the opioid scourge is to provide safer drugs for the treatment of pain that reduce or eliminate the potential for addiction and overdose deaths.
Tackling the opioid crisis is now widely accepted to involve multiple approaches:
1. Prevention of Opioid Misuse/Reduced Usage and Addiction
2. Reduce Overdose Deaths and Other Harmful Consequences
3. Improve Treatment Options for Opioid Use Disorder
Mucodel recognizes that opioid drugs are indispensable tools in the pharmaceutical armamentarium for the treatment of pain. Mucodel’s lead candidate Nasobain is a safer kappa opioid with much lower potential for strong drug-seeking behavior while also avoiding overdose risks. These unique characteristics retain physician access to a strong analgesic for short-term pain treatment while remaining confident in a reduced probability of patients migrating to more powerful street opioids and also mitigating the possibility of accidental overdose deaths.
Mucodel’s development candidates utilize its core technology platform, Co-Gel. Go-Gel technology involves the mixture of two distinct liquids/gels (Gel-A & Gel-B) at the site of mucosal administration (e.g. buccal or intranasal). This enables Co-Gel to deliver a combined gel at optimal pH for absorption wherein the drug is in a state of supersaturation long enough to affect the intended absorption across the mucosal surface. Multiple pilot human clinical studies have validated the efficacy of the Co-Gel approach. Our patented Co-Gel technology allows us to reach absorption results that are comparable to intramuscular injection.
The product is delivered via a compact, unit-dose device. The device has two chambers to house the two gels and also has a single nozzle such that when the plunger is depressed, Gel-A and Gel-B are ejected together through a screw-threaded static mixer nozzle to form an intimately mixed Co-Gel prior to use.
The Co-Gel formulation is designed for rapid absorption of drugs at the mucosal surface:
The gels flow readily prior to mixing and while at room temperature allowing facile expulsion of the individual gels from the syringe.
Crystallization inhibitors ensure that un-ionized drug remains in supersaturated solution for several minutes in the high pH/low solubility environment.
The Co-Gel has increased viscosity upon reaching body temperature limiting rapid drainage away from the administration site.
The pH of combined gel is close to the pH of maximum absorption.
The Co-Gel hydrogel presents dissolved drug at the mucosa.
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 costs compared to competing products requiring sterile manufacture
Similar rapid onset on par with intramuscular (IM) injection despite the non-invasive oromucosal route
Equal extent of absorption compared to intranasal spray
MDL-004 (Nasobain®) - Intranasal Nalbuphine for Analgesia
Exonal® has been demonstrated in Nasobain™: Most clinically useful opioids achieve their analgesic effect through binding and activation of mu-opioid receptors. This comes with attendant side effects of euphoria, physical dependence, respiratory depression, constipation, and pruritis. What is less appreciated is that significant analgesia can be obtained through activation of the kappa-opioid receptor alone. Nalbuphine is a mixed agonist-antagonist opioid drug – the drug is an agonist at the kappa-opioid receptor and an antagonist at the mu-opioid receptor. The drug is notably less euphorogenic and very likely to precipitate withdrawal in mu-opioid dependent subjects. Nalbuphine was approved as a parenteral solution for IM, IV and SC use in 1978 and is regularly used to achieve analgesia in the hospital or clinical settings. It is the only opioid drug de-scheduled by the US DEA upon the recommendation of the HHS. However, it is typically used only in a hospital or inpatient setting because poor oral bioavailability limits it to the injectable route of administration. There is no approved oral product. On a mg basis, the drug is about equianalgesic to morphine without the abuse liability while also exhibiting a ceiling effect that minimizes the potential for fatal respiratory depression.
MDL-004 has been demonstrated in pilot clinical trials to deliver peak concentration within ten minutes; This is comparable to the reference listed intramuscular therapy.
MDL-003 (Exopam – Buccal Diazepam) - Seizure
Exonal® has been demonstrated in pilot clinical trials to deliver effective levels of naloxone as rapidly as the reference listed intramuscular. MDL-003 has been demonstrated in pilot clinical trials to deliver higher peak concentration of diazepam than the reference rectal gel product at comparable doses.
MDL-002 (Exolac – Buccal Ketorolac) - Analgesia
MDL-002 has been demonstrated in pilot clinical trials to deliver faster and deliver higher peak concentration of ketorolac than the marketed intramuscular formulation and a peak concentration more than twice as high as the approved nasal spray.
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