CIDEM-255 “Development of an innovative fixed-dose drug combination for the treatment of mixed cancer pain

Proyecto de Negocio

Therapeutic Area :

Chronic Pain

Project Description:

Cancer pain can be caused by the disease itself or by surgery, chemotherapy and other associated treatments. There are several drugs indicated for the treatment of cancer pain. The drugs used for this purpose depend on the severity of the pain; for example, strong opioids are preferentially used for severe pain, while non-opioids such as paracetamol and NSAIDs are preferred for treating mild to moderate cancer pain.

The growth of the global market for drugs prescribed for oncologic pain is mainly driven by the increasing prevalence of cancer, the increase in the geriatric population, the rise in healthcare spending and the increased investment in R&D activities by various healthcare companies.

Within the research lines of CIDEM, different therapeutic candidates, new and/or known, are evaluated with significant results that allow the industrial introduction of drugs that can be used in the treatment of pain. In this sense, CIDEM-255, a fixed-dose combination of amitriptyline + paracetamol, was evaluated by means of an experimental methodology for the development of isobolographic preclinical studies, which demonstrated the absence of pharmacological interactions between the active ingredients studied and their safety for use in the multimodal treatment of chronic pain. Currently, this project is initiating technological development.

Main Results in Preclinical Studies:

The preclinical studies, conducted in two animal models, demonstrated the synergy of the proposed combination, supporting the results in pharmacological interaction and safety studies for the reduction of persistent pain, proportions, safety and neuroprotective capacity, aimed primarily at the treatment of mixed cancer pain that can be incorporated as another option in the WHO staircase strategy in its level 1 for the treatment of mild pain.

This synergy leads to a reduction in dosage and adverse effects, thus leading to a greater efficacy-safety balance in this type of patient, particularly for paracetamol known for its hepatic and renal toxicities, which in the composition is reduced by more than ¼ of its usual daily dose.

In studies on the toxicological potential of CIDEM-255, no toxic symptoms or mortality were observed in treated animals, which supports the use of an antidepressant in combination with another drug for the treatment of pain.

It is also known that pharmacological synergy following the joint administration of two molecules means that the resulting effect exceeds the sum of the effect of the two drugs administered separately. The administration of drugs at fixed doses leads to rationalization of treatments and simplification of the dosage regimen, improving therapeutic treatments with very good patient acceptance.

Intellectual Property :

“Fixed dose composition of paracetamol: amitriptyline and method for the treatment of mixed cancer pain”. PCT/CU2019/050002; WO/2019/210889

GRANTED		IN PROCEDURES
Country	Concession No.	Country	Patent Application No.
Cuba	24555	Brazil	11 2020 019985 0
USA	11590091	Eurasian	202092145

Competitive Advantages :

The advantages of fixed-dose combinations of drugs are perfectly described, the most significant of which are the use of lower doses and the improvement in tolerance compared to the increase in the doses of the drugs that make up the combination if they were used in isolation. The reduction in dosage leads to marked benefits in terms of reduction of adverse effects, offering a better efficacy-safety balance in pharmacological treatment, facilitating prescription and adherence to treatment by reducing the amount of drugs that patients must consume. These benefits were demonstrated for CIDEM-255, as a result of the studies performed, which demonstrated its safety for more efficient and safe extrapolation to humans.

Business Proposal :

Corporate alliances are required to develop collaboration and/or business modalities, such as:

Licensing and/or co-development agreements.
International Economic Partnership: Start-up Joint Ventures or Special Purpose Companies.

Main publications :

Contact Details :

Name: PhD. Alejandro Saúl Padrón Yaquis
Position: General Director
E-mail address: alejandro.padron@cidem.cu
Phone numbers: +53 7215-2192 / +53 7881-0818
Address: Ave 26 No. 1605 e / Calzada de Boyeros y Calzada de Puentes Grandes, Plaza de la Revolución. Habana-Cuba.
Web site: www.cidem.cu

Proyecto de Negocio