Millions of people suffer from neuropathic pain worldwide. Symptoms of neuropathy include loss of sensation, paradox hypersensitivity and spontaneous pain and are most commonly related to the damage of the nervous system. Neuropathy is typically caused by damaged nerve endings in the limbs, diabetes or circulatory failures resulting from contagious diseases with complications. To understand the severity of this problem, it is enough to consider that 800,000 persons suffer from diabetes in Hungary, half of whom develop polyneuropathy. This type of pain cannot be treated by ordinary painkillers because such medicines have only partial effects in only a small percentage of patients, often with unpleasant or dose-restrictive side-effects.
International research tends to confirm the headway of combination therapies, but new original medicines often fail to bring the desired results. The Lamotrigin/Sertralin agent combination developed by Meditop Kft. has got a good chance to achieve a breakthrough, since the components of the original fix combination medicine, which is based on the interaction of two (antidepressant and antiepileptic) medicines, have already been used separately for treating similar pains. The efficacy of the new medicine seems to be confirmed by clinical tests – international, randomized, multicentric, double-blind, placebo-controlled tests conducted on 182 persons – where the reactions of patients with chronic waist pain were monitored and compared to those of a control group.
The following sub-processes were completed within the project:
- development and validation of laboratory and semi-plant manufacturing technology for quick-release film-coated tablets for the purpose of clinical tests (30 mg Lamotrigin, 15 mg Sertralin, and other versions with different analysis of agents for further clinical tests)
- stability test of the medicine against the ICH international standard, development of methodology for analytical test, validation of cleaning of manufacturing equipment
- production of clinical test sample in pills with and without active agents (placebo), in a double-blind packaging system
- preparation of the licensing documentation and examination protocol of the clinical test, and contracting with the selected test centres after the completion of the licensing process
- test completed in the test centres before the scheduled deadline, with the involvement of a number of patients prescribed by the protocol
- evaluation of test results and preparation of an expert report
The series of tests covered symptoms with both nerve-root (i.e. where the nerve leaves the spinal cord) and non-nerve-root related causes. Patients treated with the tested substance showed more improvement in both groups in respect of all efficacy indicators than those in the control group where the substance was not used, though the statistical validation of this result needs to be performed later. Nevertheless, the test clearly proved that the condition of patients not exhibiting nerve-root related symptoms can be improved more than the condition of those with such symptoms: 30% less of the patients required rescue medication in the former group than in the placebo group. All this suggests that the combination medicine developed by Meditop Kft may be efficient to patients with no nerve-root related symptoms, however further clinical tests need to be performed to confirm this hypothesis on a statistical basis to the National Institute of Pharmacy and Nutrition as a registration authority. Another important outcome is that the patients tolerated the medication well: the side-effects possibly attributed to the treatment were not significantly different from those of the placebo group.
As the new original combination seems to be efficient with an improved side-effect profile, the results can bring a breakthrough in the field of a disease affecting many people, which has been in the focus of medical experiments worldwide. The successful continuation of the project is a great opportunity not only for Meditop Kft but also for the entire Hungarian pharmaceutical sector, since the product is already patented for this specific indication within the EU, the Commonwealth of Independent States, India, Australia, New Zealand and South Africa.
Funded project: KMR_12-1-2012-0102
Development of an efficient combination medicine for treating neuropathic pain by Meditop Kft.