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Novel Naloxone Formulations

Invention Number: 
501_1810
Buccal naloxone formulations for emergency opiate overdose reversal.

Introduction

Naloxone is a drug that is used to block the effects of opioids, particularly in overdose. It is typically administered to patients by intramuscular or subcutaneous injection. Whilst first responders may be familiar with this practice, family members and/or friends of the patient may find it difficult. The FDA has approved a hand-held automatic injector for non-medical settings, but it is expensive and doesn’t overcome the issue of the potential risk introduced by needles.

The present technology confers significant advantages over existing Naloxone formulations as it is needle-free, easily transportable and may be administered by non-medical professionals. In addition, it offers an improvement over other non-injectable formulations such as nasal sprays as lower doses are required (reduced risk of immediate reuse). It is also administrable to unconscious patients and individuals with damaged nasal membranes.

Commercial Opportunity

KCL is seeking a partner for the further development and validation of this opportunity. 

Key Benefits

  • Needle-free
  • Transportable
  • Easily administered

Results

The team have developed a novel buccal tablet for the rapid delivery of Naloxone in opioid overdose reversal. The tablets have been shown to be both chemically and physically stable for 9 months when stored at 25C. Under buccal conditions, full disintegration of the tablet was observed at between 5 and 20s, depending on temperature. The buccal tablet is currently being tested in a phase 1 clinical trial and is being compared with intravenous and intramuscular Naloxone in healthy subjects.

Patent Status

PCT application (PCT/GB2016/050682). 

KCL Principle Investigator: Sir Professor John Strang 

References

Amorphous Formulation and in Vitro Performance Testing of Instantly Disintegrating Buccal Tablets for the Emergency Delivery of Naloxone. Alqurshi et al. Mol. Pharmaceutics, 2016, 13 (5), pp 1688–1698.

Contact

Dr Jenny Worthington, IP & Licensing Executive
King’s College London
Email: jenny.worthington@kcl.ac.uk
Tel: + 44 (0) 207 848 8125