Mucodel Pharma LLC recently announced it has received a notice of allowance from the United States Patent and Trademark Office for its utility patent application titled Chemically Stable and Oromucosally Absorbable Gel Compositions of a Pharmaceutical Active Agent in a Multi-Chambered Delivery System (US Application No. 14/820,081).
The allowed claims cover Mucodel’s buccal naloxone candidate, Exonal. Mucodel previously announced its successful completion of a pilot clinical study involving Exonal. This pilot pharmacokinetic study compared Exonal buccal naloxone with an approved intramuscular (IM) naloxone. The study met its objectives and demonstrated that Exonal rapidly delivered the targeted naloxone dose, with comparable Cmax and Tmax to the approved IM reference product.
Naloxone is an 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).
Currently, there is no approved naloxone rescue product with an oromucosal route of administration. FDA approved formulations of rescue naloxone are limited to injectable products and a nasal spray.
Mucodel previously filed a Citizen Petition requesting the FDA to consider whether new intranasal (IN) naloxone applications adequately address the potential efficacy disparity between IN naloxone and IM naloxone in actual field use.
Mucodel CEO and inventor, Madhu Hariharan, commented “We are gratified by the first patent allowance for our Co-Gel platform. Exonal represents a substantial milestone for Mucodel and our Co-Gel platform, as naloxone has heretofore not been understood to be deliverable via the oromucosal route. We are actively building on our Co-Gel platform with other product candidates, including buccal diazepam for panic disorder, and a buccal analgesic for short- term treatment of pain indications, and an additional undisclosed candidate. Pilot bioavailability studies in man have shown very rapid absorption of buccal diazepam and the buccal analgesic further affirming our novel approach to make drugs oromucosally deliverable.”
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. For more information, visit www.mucodel.com.