IN-VIVO SAFETY AND EFFICACY EVALUATION OF A NOVEL
POLYMERIC BASED LIDOCAINE FORMULATION FOR TOPICAL
ANALGESIA
ANDREI LUCA 1,9, COSMIN-TEODOR MIHAI 1, GABRIELA-DUMITRIȚA STANCIU 1, VERONICA BILD 1,2, ELENA COJOCARU 3, ROBERT ANCUCEANU 4, VALERIA HARABAGIU 5, CRISTIAN PEPTU 5, CATALINA ANIȘOARA PEPTU 6, MAGDALENA-MARIA LEONCONSTANTIN
1,7*, TEODORA ALEXA-STRATULAT 1,8
1CEMEX Laboratory, University of Medicine and Pharmacy „Gr. T. Popa”, 9-13 Mihail Kogălniceanu Street, Iași, Romania
2Pharmacodynamics and Clinical Pharmacy Department, University of Medicine and Pharmacy „Gr. T. Popa”, 16
Universității Str., 700115, Iași, Romania
3Morphofunctional Sciences Department, Discipline of Pathology, University of Medicine and Pharmacy „Gr. T. Popa”, 16
Universității Str., 700115, Iași, Romania
4A&B Pharm Corp., Roman, Romania
5“Petru Poni” Institute of Macromolecular Chemistry, Aleea Grigore Ghica Voda 41A, 700487 Iași, Romania
6Department of Natural and Synthetic Polymers, Faculty of Chemical Engineering and Environmental Protection,
„Gheorghe Asachi” Technical University of Iași, Dimitrie Mangeron Street, 73, 700050, Romania
7First Medical Department, Discipline of Medical Semiology, University of Medicine and Pharmacy „Gr. T. Popa”,16
Universității Str., 700115, Iași, Romania
8Medical Oncology-Radiotherapy Department, University of Medicine and Pharmacy „Gr. T. Popa”, 16 Universității Str.,
700115, Iași, Romania
9Pneumology Department, University of Medicine and Pharmacy „Gr. T. Popa”, 16 Universității Str., 700115, Iași, Romania
*corresponding author: leon.maria.magdalena@gmail.com
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Abstract:
Topical analgesics currently available still have efficacy, local tolerability and price issues. The aim of this study was to
assess the efficacy of a new lidocaine-based spray (CX001) on experimental pain.Safety was assessed by histology
examination of skin and liver tissue of CX001-treated mice. The effect of CX001 on nociceptive and inflammatory pain was
assessed by periodic evaluation of the rat’s response to thermal and mechanical stimuli and compared with EMLA©
(reference topical analgesic).CX001-treated mice had no significant skin or liver modification. CX001’s analgesic effect was
superior to EMLA© in terms of response to mechanical stimuli in both the nociceptive and inflammatory pain model. The two
drugs had similar effects in terms of thermal stimuli. Our lidocaine-based innovative formula represents a novel platform for
acquiring topical analgesia. CX001 is safe and more effective than the reference cream for mechanically-induced nociceptive and
inflammatory pain.

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