A dilemma for big pharma companies : CNS Drugs
The central nervous system (CNS) is the most complicated area of clinical research. And currently the big pharma companies are keen to invest in this therapeutic area. But the R&D spends have not yet got rewarded with the desired results. R&D in this area is risky and chances of approving the drugs by the regulatory board are very slim. Hence big pharma companies are at the risk of major losses.
The budget of clinical research for developing a CNS drug versus a cardiovascular drug is 30 percent higher and the chances of a CNS drug reaching a great status in the market is about 50 percent lower.
Research and development by big pharma companies in area of diseases like depression, anxiety, schizophrenia, Alzheimer’s, Parkinson’s and stroke have invited the risks of heavy investments but very less guarantee of success.
The big companies concluded that the risks associated with CNS drug development are very high—so are they justified?
Challenges Facing CNS Drug Development
External pressures have created trouble for the pharma industry’s efforts to address CNS disorders like the active “anti-psychiatry” movement made up of organisations, politicians, religious groups and layman who does not believe the importance of psychiatric treatment.
Moreover there are also the internal pressures. For instance only 8.2% of CNS drug candidates become available for clinical use, compared with 15% of other drugs. Phase II and III of clinical trials and also the regulatory approval; all takes much longer for CNS drugs compared to other therapeutic drugs. Some CNS drugs might take 18 long years from preclinical work to marketing, and clinical research organizations rarely take the benefits of available regulatory tools like Priority Review and Fast Track designation.
Phase III failures
As per reports, most CNS R&D losses of recent years are due to the fact that the majority (4 out of 5) of CNS leads fail the most crucial and expensive phase III stage of clinical trials. And reasons are numerous that includes strict board regulations for CNS disorders to insufficient understanding of the facts underlying brain disease.
What Clinical Research Organizations (CROs) Can Do?
To mention, the figures say that CNS disorder – patients outnumber that cardiovascular disorders ones and with increase in population, the numbers with CNS disorders are increasing. To address this need, there are some ways to enhance the speed of CNS drug development like; implementing proof-of-concept studies, orchestrating studies with a singular drug development team rather than by handing off studies phase by phase, and embracing open, dose-ranging trials followed by moves to a small sample, randomized clinical trial before the move to Phase III. The idea to co-develop CNS drugs with publically sponsored research institutions can also lessen the known risks involved in the development process of CNS drug.
Effective CNS drugs can lessen patient suffering, prolong longevity, improve life-quality and address public health concerns—so it’s essential for all of involved in the drug development process of CNS to look for innovative approaches in bringing these drugs from lab to the market.
We conclude here.
The fact is that disorder associated with central nervous system need to be seriously considered and effective measures in their development process should be initiated.
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