Orexigen Therapeutics terminated the clinical trial of its obesity drug, Contrave.
Amid allegations of releasing unreliable data at the completion of only one quarter of the trial, the pharmaceutical company drew the reprobation of Cleveland Clinic’s lead research Dr. Steven Nissen, as well that of marketing partner Japanese Takeda. The United States Food And Drug Administration also announced its disapproval of practices utilized by Orexigen.
The Light Study as the clinical trial done by Cleveland Clinic was titled aimed to meet the FDA’s requirement that Orexigen needed to assess Contrave in view of cardiovascular safety for overweight and obese patients. This categories present high risks of cardiovascular complications due to diabetes or other factors.
Orexigen filed for FDA approval of Contrave after approximately 25 percent of the Light Study was completed. The prerequisites were that the results at the time took out the possibility of doubling the cardiovascular risk for patients administered Contrave. The conclusions of the partial analysis, which were intended to remain confidential, demonstrated that Contrave met FDA prerequisites.
The approval of Contrave followed on September 10, 2014. At almost the same time, the FDA signaled that Orexigen Therapeutics had violated the terms of the agreement by releasing the 25 percent interim results.
Consequently, in March, Orexigen Therapeutics claimed a patent implying that Contrave, the weight-loss drug has beneficial effects for countering cardiovascular conditions. The release of the data supporting this claim came after only one quarter of the clinical trial had been completed. Under these circumstances, misleading statements is the least the company could be charged for.
Initially, it was suggested that the 60 percent of patients who had been administered placebo drugs were more prone to developing cardiovascular problems. According to Cleveland Clinic, the figure stands more at around 12 percent, pointing out that the unofficial release of Orexigen compromised the clinical trial’s integrity.
The executive committee led by Cleveland Clinic decided to put a halt to the upcoming phases. Pharmaceutical companies simply cannot release partial and unreliable data. The Japanese pharma giant Takeda, former partner of Orexigen Therapeutics is asking for the cost of the new cardiovascular safety trial which is set to start further in the year, among other demands.
The shares of Orexigen took a plunge of 12 percent on release of the news.
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