Purdue Pharma conducting OxyContin clinical trial in kids
Although the main motive behind the initiation of clinical trial of Purdue’s painkiller medication Oxycontin is not properly understood, but the company claims that the aim behind this is to ensure safety of the drug in kids as it used extensively to relieve pain in kids as its off-label use.
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17 August 2012, USA, California(Realpharmacyrx.co): With the aim of conducting clinical trials pertaining to check the effectiveness of the drug OxyContin, Purdue pharmaceutical is planning to increase its market shares as well as enhance its monopoly by asking a six month trial period from the regulatory body, FDA.
The main reason for the clinical trial conducted by Purdue is the fact that the FDA has provided an extension of 6 months on its patent. The FDA is providing such kind of extensions as an inducement to the drug makers for performing clinical trials in kids, which was formerly a neglected area of clinical investigative study.
The company has enrolled around 150 children in the age group of 6 – 16 years to carry out the clinical intervention and test the effectiveness of this powerful and potent painkiller medication in kids. OxyContin has been used to relieve pain in children by many health care professionals as its off-label use since many years.
Sandy Walsh, a spokesperson of the FDA agency said that the providing the same range of research information pertaining to any drug to parents as well as pediatricians with regards to the drug use in children is one of the main priorities of the FDA.
The reason for a hush-hush over the Purdue trial with regards to its drug OxyContin in children is because this painkiller medication has been found to act as an addictive drug, which can be abused if used routinely. Also, the clinical trial of this drug has encouraged criticism in the pharma market.
Several health care professionals are worried about the approval of the drug for daily use, as this will result in an increased risk of children getting addicted to the drug. The drug is being tested in children experiencing excruciating pain as a result of their health complication that include post-operative pain, injuries, cancer, sickle-cell anemia or severe burns.
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