Orexigen Therapeutics Provides Statement on Termination of the Light Study and Updates on Contrave Collaboration with Takeda Pharmaceuticals
11 hours 12 minutes ago - DJNF
SAN DIEGO, May 12, 2015 /PRNewswire/ -- Orexigen Therapeutics, Inc. (Nasdaq: OREX) today issued the following statement regarding the termination of the Light Study a cardiovascular (CV) outcomes trial that compared the obesity drug Contrave(R) (naltrexone HCI and bupropion HCl extended-release tablets) to placebo, in addition to diet and exercise counselling, in 8,909 overweight and obese patients with certain CV risk factors, and an update on its Contrave collaboration with Takeda Pharmaceuticals Company.
This morning we and Takeda announced termination of the Light Study. We agreed with our partner, and together discussed our preferences with the U.S. Food and Drug Administration (FDA), that it was best to conclude the study in an orderly fashion, search for and gather all CV events and other safety data, have the CV events properly adjudicated, carefully analyze the final data and have these data presented and published in a scientific forum.
Since continuation of the Light Study was not a postmarketing requirement (PMR), and the majority of patients are no longer on blinded study drug, Orexigen had long advocated shutting down the study in December 2014, corresponding with the time of the 50% interim analysis, and focusing resources on new studies to further evaluate the therapeutic profile of Contrave.
We are pleased that the Light Study is now being terminated and want to thank the patients and all of those involved in the study. This trial has yielded important information about the safety profile for Contrave.
We have been informed that Takeda is on track to initiate a PMR cardiovascular outcomes trial (CVOT) later this year and recently achieved the first planned milestone with FDA acceptance of the study protocol in April.
Today some of the 50% interim analysis of the Light Study was disclosed by a third party. Because most of our management team remains blinded to the 50% data, we are unable to comment.
There have been a lot of challenges surrounding the use of interim data from ongoing studies for regulatory purposes. There are competing tensions for data confidentiality to preserve study integrity, transparency laws, and guidelines from regulatory bodies. With respect to the Light Study, Orexigen filed patent applications based on the unexpected result of the 25% interim analysis of LIGHT Study data. The first of those applications was granted and issued in March, and the full clinical study report that was submitted to FDA in the patent application was disclosed by the United States Patent and Trademark Office (USPTO).
A few articles on this topic have been published in the media today that include misleading statements about our company. Contrary to allegations cited today by a journalist, Orexigen has never misled patients. At the time of the patent issuance in March, we stated plainly and clearly that the effect of Contrave on CV morbidity and mortality has not been established and that a larger number of MACE are required to precisely determine the effect of Contrave on CV outcomes.
