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INNPACTO Program

Project IOTRA: “Development of a new combination of AINES”. The Ministry of Economy and Competitiveness through INNPACTO Subprogram of the National Public-Private Cooperation within the joint line and internationalization Instrumentation System, part of the National Plan for Scientific Research, Development and Technological Innovation 2008-2011, supports Farmalider, S.A projects Through grant aid including a partially deposit refundable under funding FEDER.

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CDTI: Projects funded by the Center for Industrial Technological Development

DOLOMENS15 is an individual R & D project that aims to develop a new medicine for the menstrual cramps treatment based on an ibuprofen and paracetamol combination, with 951.894 euros global budget and a work plan which covers the period between the October 16th, 2016 until June 15th, 2018.

The main objectives of the project are the following: i) drug bioavailability study with its active comparators through a 2×2 phase I cross-over trial. ii) Analgesic efficacy and safety evaluation of the paracetamol and ibuprofen fixed-dose combination for oral administration, compared to its active comparators and placebo in dysmenorrhea with moderate or severe pain patients.

The main objectives of the project are the following: i) drug bioavailability study with its active comparators through a 2×2 phase I cross-over trial. ii) Analgesic efficacy and safety evaluation of the paracetamol and ibuprofen fixed-dose combination for oral administration, compared to its active comparators and placebo in dysmenorrhea with moderate or severe pain patients.

This project has been co-financed by the CDTI with European Union FEDER funds, through the Smart Growth Pluriregional Operative Program, 2014-2020.

DATA SHEET

• Call: R&D individual CDTI Project
• Reference: IDI-20160004
• Project Title: “New medication development against menstrual cramps”
• Acronym: DOLOMENS15
• Leader: FARMALIDER, S.A.
• Budget: 951.894,00 €
• FEDER funds financing: 809,109.90 €
• Co-financing percentage: 72.96%
• Start date: 10/16/2016
• End date: 06/15/2018

ministerio-de-economia-y-competitividad


ARSIDOS-020

ARSIDOS-020 is an R&D project, coordinated and led by FARMALÍDER, which aims to develop a new oral medication for the treatment of erosive hand osteoarthritis.

To achieve this, FARMALÍDER has the collaboration of 20 hospitals throughout Spain, of which the Hospital del Mar de Barcelona will act as a reference centre. SERMES is also participating in the project as a contract research organisation (CRO) of the clinical trial.

Erosive hand osteoarthritis is a chronic pathology that occurs in middle-aged people causing severe pain and significant functional limitations. Although there are multiple treatments none of them are satisfactory as their long-term use causes unacceptable adverse effects. Further to observing how a drug used for another pathology provided considerable relief in this disease it was decided to launch a programme of “repositioning” which is precisely the ARSIDOS-020 project. This includes a new pharmaceutical form, a new dosage and a pivotal clinical trial versus placebo to demonstrate its efficacy and safety.

The project has been financed by the Center for Industrial Technological Development (CDTI) of the Department of Science and Innovation, and has an estimated duration of 33 months, from February 2020 to October 2022.

• Call: Research and Development Project (CDTI).
• Reference: IDI-20200563
• Project title: “Development of a new drug for the treatment of erosive hand osteoarthritis”
• Acronym: ARSIDOS-020
• Objective: Development of a new fast-acting, safe, effective and easy-to-administer drug (oral) for the treatment of erosive hand osteoarthritis
• Sponsor: FARMALÍDER, S.A.
• Collaborating entities: Sermes (CRO of the clinical trial) and Hospital del Mar de Barcelona (study co-ordinating centres for 19 more hospitals).
• Financial aid of the CDTI: 1.386.702,95€
• Start date: 01/02/2020
• End date: 31/10/2022


ARSIDOS-020