2017-03-006 - CLIFE-1 GEL - Topical analgesic gel for anorectal pain relief
Contacts
Acronim & Gínjol codes
CLIFE-1 GEL
2017-03-006
Main technology offer
Anorectal pain relief is managed in a comprehensive manner by the combination of a local anesthetic and a nonsteroidal anti-inflammatoryThe gel is composed by two known active substances in a safe, effective, stable and quality formula.
Ownership
L'Hospitalet de Llobregat, Spain
2004
Institut d'Investigació Biomèdica de Bellvitge (IDIBELL)
Public Partners
Readiness Level
3-4 Experimental PoC /
5 Prototype /
6-7 MVP /
8 Industrialization /
9 Commercialization
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Impact: ESG & SDG Goals
Health and Safety: effective gel for pain treatment which will lead to patient satisfaction, lower medical costs and shorter hospital stays.
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Market Data
Problem: Anorectal disorders are widespread condition affecting the general population with a prevalence of 40% in adults and 100% occasionally in elder people over 65 years old. Rectal surgery includes hemorrhoids, anal fistula and anal fissure, having hemorrhoids a prevalence rate of 4.4% among all population. Hemorrhoids are an extremely common condition, affecting approximately 10 million persons per year. One study estimated that more than 50% of the US population over age 50 years has experienced hemorrhoids. Postoperative pain is handled in such many different ways that none of them is purely effective. There is no topical alternative for the treatment of postoperative pain in anorectal benign surgery due to medical contraindications of existing products. Current pain solutions proposed require use of burdensome devices and are uncomfortable for the patients.
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IDIBELL has a company partner (Procare Health) to further develop the technology through a licensing agreement.
Anorectal disorders are commonly encountered in general surgical practice and as a chronic disease. These disorders are common, worldwide and their prevalence in the general population is probably much higher than that seen in clinical practice as most patients do not seek medical attention. Patients with diseases of the anus and rectum are usually in pain, often anxious and frequently embarrassed by the examination. 3.25 million units of antihemorroïdals were sold in the last 12 months (period from October 12 - to September 13) only in the Spanish market, with a value of 17.2 M € (in PVL value). The topical treatment proposed for anorectal pain is new, unique and directed to a necessary field of application with strong market demand.
This topical gel can be used in pre and post anorectal surgery (such as hemorrhoids, anal fistula and anal fissure, among others) patients to relief local pain. It can also be used to treat pain in anorectal persisting disorders.
Funding
Commercializing the gel as an OTC product.
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Obtain EMA's approval.
Technology Status
This is a new semi-solid pharmaceutical drug for topical rectal administration in the treatment of pre and post-operative period in benign anorectal surgery. Most existing topical formulations contain corticoid, contraindicated in surgical wounds. With this innovation, pain is managed in a comprehensive manner, thanks to the combination of a local anesthetic and a nonsteroidal anti-inflammatory. The use of topical gel allows putting aside analgesic current technologies that are more complex and iatrogenic such as analgesia administration by epidural PCA pumps, that prolong hospital stay, or subcutaneously elastomeric pumps at home, unpleasant for the patient and requiring training for its use. It is composed by two known active substances, but never combined before for this indication, in a safe, effective, stable and quality formula.
Obtain EMA's approval for commercializing the gel as an OTC product.
1. Scouting of companies that could help in the regulatory process. 2. Estimate the budgets and select one of the companies. Procare will be responsible for covering the costs of the contracted company. 3. The selected company will be responsible for managing and carrying out the necessary procedures to obtain OTC product approval. 4. Start commercialization and receive royalties.
European Patent: EP16750740.9 Spanish Patent: ES2774484 Patents: WO2017021481A1 ; PCT/EP2016/068618 - Feb 9th, 2017 - Status: Granted - URL: https://patents.google.com/patent/WO2017021481A1/en
Additional information
The technology will lead to patient satisfaction, lower medical costs and shorter hospital stays