Sciele Pharma, Addrenex Submit sNDA To FDA For Clonicel
For the treatment of attention deficit hyperactivity disorder
Sciele Pharma and Addrenex Pharmaceuticals have announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the FDA for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder (ADHD).
In multi-center, placebo-controlled, double-blind, randomised phase III clinical trials, Clonicel showed statistical significance when used to treat ADHD.
Ed Schutter, president and chief operating officer of Sciele Pharma, said: “We are pleased that Addrenex has filed the sNDA with the FDA. Clonicel is an important product in our pediatric pipeline, and we are excited about the potential benefit that Clonicel may provide to children and adolescents who have ADHD.”
Moise Khayrallah, chief executive officer of Addrenex Pharmaceuticals, said: “Clonicel was designed to normalise excess adrenergic hormones that may cause symptoms of ADHD. In phase III clinical trials, Clonicel demonstrated an improvement in an aggregate of 18 ADHD symptoms recognised by the American Psychiatric Association and used by doctors to diagnose and classify ADHD in children and adolescents.”
In July 2007, Sciele signed an exclusive licensing agreement with Addrenex to market its modified-release formulation of clonidine hydrochloride for the treatment of ADHD and hypertension in the US, Mexico and Canada.
Related Insight
Suppliers Directory
Drug Research Drug Delivery Drug Discovery & Development
Contract Research & Services Clinical Trials Contract Research Contract Services
Automation IT & Software Laboratory Instrumentation
Inward Investment Packaging Regulatory Affairs
Intelligence
GBI Research, the leading business intelligence provider, has released its latest report, “Nanotechnology in Drug Delivery - Technological Improvements and Novel Approaches to Fulfill High Potential” that provides key data, information and analysis of the major trends and issues affecting the global nano-enabled drug delivery market. The report provides a comprehensive insight into the current and future application of nanotechnology in the drug delivery systems. It also provides an insight into the key drivers and barriers for the market growth. The report also provides a detailed analysis of the trends and its effects on the nano-enabled drug delivery market. The report also talks about the key regulations that affect the nanotechnology research and development and issues related to its use in pharmaceutical market. The report also details some case study of the latest technology being exploited in pharmaceutical industry. The report also provides detailed analysis of major deals that have happened in the nano-enabled drug delivery market landscape. At the end, the report looks into the future players. This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research’s team of industry experts. The nano-enabled drug delivery market has been a high growth market and expected to grow at a faster rate in the near future. According to a study conducted by Willi Paul, and Chandra P. Sharma, the nano-enabled drug delivery market was $1.7 billion in 2009 and expected to reach over $4.8 billion in 2012. The market will witness increased competition, high investment from venture capitalist and government. The M&A and Licensing landscape will see significant changes in the coming future. This is because market is expected to become more lucrative in coming future. The major drivers for the market growth are Increasing acceptance of nano-enabled drugs, and a strong pipeline portfolio. The increasing governmental funding and R&D interest will strengthen the market in future. However, lack of consistent policy on technology transfer, poor R&D facility, and tight audit control and lack of centralized system will restrain the market growth. The nano-enabled drug delivery market has strong pipeline. The pipeline is primarily dominated by molecules in early stage of development. This suggests that the there is high level of R&D investment. This will support the future market and will fuel the licensing activity. Reports Buy online from $3500
Comments may be moderated for spam, obscenities or defamation.