SCN’s Cough and Cold Product May Reach OTC Status in USA and EU within two years
Building on support from two independent evaluations, Scandinavian Clinical Nutrition AB (SCN) is optimistic about getting its patented substance troxerutin registered as an over-the-counter (OTC) drug in USA and EU within two years. According to international expertise, the project should be possible to carry out with relatively small investments.
“The response from the independent experts at the external contract research organizations (CROs) we have used for the evaluations, of which one is the Norwegian Link Medical Research, is very positive. We are very optimistic about managing to register our troxerutin preparation as an OTC drug against cold symptoms in USA and EU within the next two years”, says Ulf Söderberg, CEO of SCN.
The conclusions in the CRO reports are supported by one of the world’s most renowned experts on registration processes, Professor Bernd Kümmel from Germany. After evaluating the troxerutin case, Professor Kümmel concludes: “I see little reason to doubt that a successful OTC registration process for the product could be carried out with very moderate investments”.
The substance troxerutin has been registered as an OTC drug in both USA and EU for more than 30 years for the indication “leakage in the veins”. Due to this fact, SCN does not have to make heavy investments in pre-clinical studies and research, which saves both time and money in the development process. Previous studies have shown that troxerutin relieves critical symptoms of the common cold within 24 hours. SCN has a world-wide patent for cough and cold symptoms related to troxerutin. The patent covers all effects of troxerutin in the upper respiratory tract, which means that SCN will have world-wide exclusivity for use of troxerutin in cough and cold products.
“The fact that SCN now aims to take the active ingredient in the dietary supplement Coldizin* to OTC status is a good illustration of our strategy to develop products on all levels in the value chain for nutraceuticals, from dietary supplements to OTC drugs, by using solid science. It is also a clear indication of the importance and value of our 10-year R&D agreement with Karolinska Institutet”, says Dan Edwall, VP R&D of SCN.
The market for cold products is large and growing. In 2006, the US market alone amounted to USD 5.9 billion, and the growth rate is significant. Colds are also a problem for the public health care: according to a recent study by the University of Michigan Health System, the cost of common colds to the U.S. economy is USD 40 billion a year. There are also signs of increasing consolidation, for example the recent USD 2.2 billion Reckitt Benckiser acquisition of Adams Respiratory Therapeutics Inc. and their OTC registered cold product Mucinex.
“SCN sees the ongoing consolidation of the OTC market for cold products as a clear indication of confidence in the market, and this supports us in our ambition to make a leading OTC drug against cold symptoms in USA and EU”, says Ulf Söderberg.