Orexigen pleases shareholders, irks FDA
A Securities and Exchange Commission filing landed Orexigen Therapeutics in hot water because it revealed information the FDA wanted kept private until the cardiovascular safety trial of its weight-loss drug Contrave had been completed.
Forbes reported that this is not the first time results from the Light study have surfaced too early—the FDA previously told Orexigen it had been too quick to share information about Contrave with too many people in-house.
The Wall Street Journal noted that the most recent disclosure, which was part of a patent application, caused the company's share price to almost double because the information indicated that the drug may be associated with a reduction in cardiovascular risks.
The Journal explained that the FDA is concerned that the early results could encourage patients to leave the trial if they think they are receiving the placebo.
RBC Capital Markets analyst Simos Simeonidis told the Journal that Orexigen was in a bind of sorts. He said that although sharing the data irked the FDA, the data is also an essential part of its patent filing and that not filing the patent application could be construed as failing its stockholders.
The concern with this early reveal is similar to those concerns raised over the summer about clinical trial patients sharing their experiences on social media channels including Facebook and Twitter and how that impacts trial participation.
The Journal noted then, too, that researchers were worried that patients may drop out of clinical trials if online conversations convince them they are getting the placebo instead of the drug that is being tested.